FDA Approves New Cholesterol Drug

The Food and Drug Administration has approved the first of a new class of cholesterol drugs aimed at helping people with a hard-to-treat, inherited form of high cholesterol.

The drug, called Praluent, must be injected, so it won't be as easy to take as a pill. Because it's in a class of biotech drugs called monoclonal antibodies, it will be pricey — $14,000 a year.

It's in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. It targets PCSK9, a protein that affects the liver's ability to take LDL or "bad" cholesterol out of the blood.

FDA Approves Onyx Cancer Drug

New drugs for breast cancer and multiple myeloma won approval from the Food and Drug Administration on Friday, expanding options for patients in advanced stages of those diseases.

The breast cancer drug, Afinitor from Novartis, seems to expand the time that endocrine therapy can keep the disease in check. The multiple myeloma drug, Kyprolis from Onyx Pharmaceuticals, was approved for use when at least two other drugs have failed.

Afinitor was approved for use by a large segment of breast cancer patients — postmenopausal women with hormone receptor-positive disease. These women are often treated with drugs called aromatase inhibitors, which deprive the tumors of the hormone estrogen, which can fuel their growth.

But tumors can become resistant to those drugs. The addition of Afinitor appears to restore their effectiveness.

“It’s exciting,” said Dr. Melody Cobleigh, director of the breast cancer program at Rush University Medical Center in Chicago. “We have figured out a way that tumor cells become resistant to existing therapies and a way to reverse that resistance.”

The clinical trial that led to approval involved 724 women with advanced breast cancer that was no longer being controlled by either Femara or Arimidex, two aromatase inhibitors.

All the women were given a slightly different aromatase inhibitor called Aromasin, also known as exemestane. Some, chosen at random, also received Afinitor while the others got a placebo.

Cancer began to worsen in a median of only 3.2 months for the women who got exemestane plus the placebo. That is not surprising because the tumors were already resistant to aromatase inhibitors. But the patients who also received Afinitor went a median of 7.8 months before their disease began progressing.

Still, Dr. Harold J. Burstein, a breast cancer specialist at the Dana-Farber Cancer Institute in Boston, said the gains were modest, especially given that Afinitor can cause serious side effects like mouth sores and lung inflammation. “I don’t know that it’s one that is going to radically change the near-term face of advanced breast cancer,” he said.

Afinitor, known generically as everolimus, works by inhibiting a protein in the body called mTOR, which is involved in cell growth and other processes.

Afinitor is already on the market as treatment for kidney cancer and some rarer tumors. The approval for the much more common breast cancer could sharply increase sales of the drug, which were $318 million in the first half of this year.

“We feel very confident taking our sales forecast well above $1 billion in breast cancer,” David Epstein, the head of pharmaceuticals for Novartis, said on the company’s earnings conference call on Thursday.

Afinitor, a tablet, has a wholesale cost of about $7,500 for a 28-day supply, the company said. American depositary receipts of Novartis, which is based in Switzerland, fell 27 cents, to $57.09 on the New York Stock Exchange on Friday.

Kyprolis, the new drug for multiple myeloma, received accelerated approval, under which drugs for life-threatening diseases can be approved with less than the usually required evidence, subject to further study.

In a clinical trial with no control group, the drug significantly shrank tumors in 23 percent of patients who had relapsed after receiving at least two previous therapies.

Multiple myeloma is a cancer of the bone marrow. An estimated 21,700 people will get the cancer this year and 10,700 will die from it, according to the American Cancer Society.

source: nytimes

Low estrogen levels causes bone weakness

Low Estrogen Levels May Hit Bones Strength

Once a women hits menopause around the age of fifty and estrogen levels are not checked, some symptoms may get even worse. When estrogen levels drop, they have an negative effect on another hormone- the stress hormone cortisol. (Paradoxically, too much cortisol can lower your estrogen levels).

The combination of low estrogen and constantly elevated cortisol may lead to a condition called crashing fatigue. Crashing fatigue is a common and disturbing symptom of menopause. It makes women feel deeply exhausted even though they haven’t made any physical effort. Similar to chronic fatigue, crashing fatigue can be debilitating as overall stamina declines and is worsened by physical or mental activity. It’s an endless feeling of tiredness, all because natural levels of estrogens have declined. Bye-bye energy.

Because the symptoms can be so varied, it may be beneficial to keep a symptom long to determine whether low estrogen levels are the contributor to a lack of energy. Some signs to look for include panic attacks, migraines, and palpitations that occur for one to two days around ovulation or around menstruation. For those with chronic fatigue of fibromyalgia, be on the alert: If symptoms are worse the week before a period – or if there is decreased vaginal lubrication – low estrogen is most likely the culprit.

ESTROGEN DOMINANCE
On the other side of the coin are the problems with elevated estrogen. When estrogen levels are too high, you’re looking at anxiety, weight gain, water retention, headaches, poor quality sleep, and fatigue. Certainly nothing likely to boost your energy.

How can you wind up with too much estrogen? It’s not hard. We’re accustomed to thinking of declining levels of estrogen as an accompaniment of aging. It seems counter-intuitive that estrogen levels might rise as we age. But in fact, this somewhat weird paradox probably happens more often than you might think.

How can this be? It’s certainly not because women are producing more estrogen internally. Rather, it’s because our environment is now chock-full of weird chemicals and compounds that actually act like estrogen. There’s even a term for them – estrogenic mimics. These estrogenic compounds, sometimes also called hormone disruptioners, are all over the place (one recently discovered source is plastics). And they can be fiendishly difficult to get rid of. Many women (and men!) have a difficult time eliminating these exogenous (outside the body) estrogens because of damaged metabolisms and sluggish livers. Nutritionists and researchers call this condition estrogen dominance.

THE YIN AND YANG OF ESTROGEN
One of the results of estrogen dominance is fatigue. Here’s how it works: Estrogen is what’s known as a pro-growth hormone because it stimulates activity. But like everything in the body, it has a counterbalancing force, which in this case is another hormone, progesterone.

Progesterone works antagonistically with estrogen to maintain homeostasis, or balance. (Remember the Goldilocks mantra: not too hot, not too cold). When estrogen increases during the menstrual cycle, progesterone decreases. When estrogen decreases, progesterone increases, in a lovely hormonal version of a seesaw. They work in perfect harmony throughout each month, or at least they do theoretically. (I have some friends with server PMS who might argue differently, as would their husbands and boyfriends).

Everything moves along pretty swimmingly until around age thirty-five or so. Somewhere around this point or later, at the start of what’s called permenopause, estrogen and progesterone both begin to decline. In an ideal world, they would decline at the same levels, to maintain that optimal ratio, but like most situations that start out with the preface “in an ideal world”, this rarely happens. In fact, while estrogen levels will decline about 35 percent through menopause, progesterone levels will take a virtual nosedive, declining a whopping 75 percent. That peaceful seesaw starts to look like one side has a two-year-old on it and the other side has an elephant.

Per menopause can last anywhere from two to ten years, and although most women may notice some symptoms, they are often told by their oh-so-helpful doctors that there is really nothing that can be done about them. “It’s just the way it is” is a common refrain. The less sensitive have been known to mumble under their breaths, “Oh, just live with it!.

To make matters worse, many doctors only check blood levels of estrogen (if they check blood levels at all, something they unfortunately don’t always do). Assuming symptoms are simply caused by declining estrogen, many will recommend birth control pills as a way of raising estrogen levels. This may provide some temporary and much-needed relief from symptoms but can further upset a rapidly devolving delicate balance. Over time, synthetic drugs such as birth control pills may further deplete women of necessary nutrients and can ultimately create even more hormonal imbalances.

By menopause, the total amount of progesterone made is extremely low, while estrogen is still present in the body at about half its premenopausal level. Estrogen dominance is the result, and the effects are rarely pretty.

HEAVE THE HORMONE DISRUPTERS
It gets worse. Remember those estrogen mimics we talked about? Commercially raised cattle and poultry are loaded with them. They’re in the very food eaten by the livestock that aren’t pasture fed and organic, meaning they make their way into the meat we eat as well (yet another in the hundred or so reasons I keep urging anyone who will listen to try to eat only grass-fed meat. I know it’s more expensive – just eat less of it!).

Pesticide residues have chemical structures that are similar to those of estrogen, making them estrogen mimics; we sometimes refer to them as xenoestrogens (xeno meaning “foreign”). Produce known to contain the highest levels of pesticides are strawberries, peppers, apples, spinach, and celery. And xenoestrogens are all over the place, not just in our food: they’re also found in plastics, nail polish, cosmetics, glues, and adhesives, as well as dioxin-containing foods such as the aforementioned meat, milk, eggs, and fish.

Both caffeine and alcohol can raise estrogen levels. Ovarian cysts or tumors can and do make extra estrogen. Stress will ultimately reduce progesterone levels.* (Stress overall can do much damage to many hormonal systems that are regulated through the adrenal glands). Too much stress and a reduction in progesterone will further upset the delicate estrogen/progesterone balance. When this happens, we expeince insomnia, anxiety, and an even greater depletion of energy.

*According to Robert Sapolsky, Ph.D., too much stress can also reduce estrogen.

BALANCE YOUR ESTROGEN, BALANCE YOUR LIFE
Even a cursory reading of the above material makes it clear that balancing hormones in a healthy way can be a real challenge. But it’s absolutely essential to having a ton of energy. No kidding. And there are lots of lifestyle guidelines that women can follow to minimize the onslaught of some of the unhealthy estrogens.

Fill up on fiber. A plant-based, unprocessed, whole-food diet is the best diet for a healthy metabolism and healthy hormonal balance. Try to include at least 20 grams of fiber each day, through flaxseeds, fresh fruits and vegetables, and even fiber supplements. The fiber will help you metabolize excess estrogens. If you eat animal products, including dairy, make sure they are organic and free of hormones as well as pesticides.

Drink plenty of filtered water to help you body eliminate excess toxins and environmental estrogens. Avoid high-glycemic foods such as refined sugar, and alcohol or drugs that can damage the liver, which will lead to an increase in estrogen due to the lack of estrogen breakdown.

Choose lots of cruciferous veggies such as Brussels sprouts, broccoli, cauliflower, cabbage, kale, and soy. These foods, all of which (except for soy) are in the brassica family, are vegetable royalty. They contain phytoestrogens, compounds that are similar in structure to estrogen but much, much weaker in potency. Which is a good thing. Phytoestrogens occupy the “parking spots” reserved for estrogen (called estrogen receptors), but with much less bioactivity. By occupying the estrogen receptor sites on cell membranes, they essentially block the stronger, natural estrogen from occupying the space. Those who have estrogen dominance may therefore experience relief of symptoms and renewed sense of energy.

These foods pack a double whammy. All members of the cabbage family contain plant chemicals called indoles, which actually act as estrogen traffic cops, helping to direct estrogen metabolism down the pathways to the less harmful metabolites – such as the innocuous 2-hydroxy-estrone- rather than the much more potent 16-hydroxy-estrone, an estrogen metabolite that can be a real problem, especially in hormone-dependent cancers.


How To Prevent Osteoporosis and Osteopenia

Fatigue supplements are actually misbranded drugs: FDA

A commercial website for people suffering from symptoms of chronic fatigue syndrome and fibromyalgia is rife with numerous illegal and misleading treatment claims, according to a recent warning letter sent to Dr. Jacob Teitelbaum by the U.S. Food and Drug Administration.

Teitelbaum, the medical director of the national Fibromyalgia and Fatigue Centers and author of several books on the topic, including “From Fatigued to Fantastic!” also unlawfully used his Facebook account to promote his products for disease treatment and prevention, the FDA said in the three-page letter.

More than a dozen of products on the Teitelbaum’s website endfatigue.com are marketed with therapeutic claims – meaning they can prevent, cure or treat disease -- which classifies them as drugs, the FDA said. But the supplements have not been approved as drugs by the FDA and do not have Generally Recognized As Safe or GRAS status.

The products are also promoted for treating conditions shouldn’t be self diagnosed or treated by non-medical practitioners, the FDA said. As a result, they don’t have adequate directions for use and are considered “misbranded.”

The FDA found the section on Teitelbaum’s website titled “Cures A-Z,” especially problematic because it listed a number of medical conditions with information on how to treat these conditions – along with products offered for sale through the website.

For example, it recommended “Eskimo 3 Fish Oil” as a treatment for Alzheimer’s Disease and claimed the product could “help treat any hidden depression which may be present.”

On the web page titled, “Breast Cancer,” under the heading, “TREATMENT,” it recommended Coenzyme Q10 and claimed that “[E]arly experience showed these nutrients may decrease breast cancer growth.” The Website also recommended specific supplements to treat colds and flu, hypertension, Parkinson’s Disease, heart disease and reduce cholesterol.

And in one example of a Facebook post, Teitelbaum wrote that he looked at a new study “showing that an herbal can beat the pants off a pain medication when managing arthritis,” according to the warning letter. In that post, he included a link titled, “Herbal Beats Pain Medication in New Arthritis Study,” which links to his website, endfatigue.com. “The webpage accessible through that link includes the claim described above for your Healthy Knees and Joints product,” the FDA said.

The FDA’s surveillance of false or misleading claims on Facebook is of great interest to the supplement industry. One important lesson for manufacturers is “the continued tendency for the FDA to consider social media as a source for illegal claims, when linked to products for sale,” wrote the Natural Products Insider. “There is no safe haven in Facebook or Twitter.”

In a statement, Teitelbaum characterized himself as a “patient advocate reporting on thousands of scientific studies.” His goal is to “help people become aware of the pros and cons of new research on both natural health products and prescription treatment options.”

Teitelbaum said he recognized the need for the regulations but was “surprised” by FDA’s letter. The “Cures A-Z” section is no longer on the site; Teitelbaum said he is working with the agency to address concerns.

“Current FDA regulations do not allow disease-related claims to be made for natural products, unless the product has gone through the FDA drug approval process, which can cost upward of $500 million, making this impossible for most non-patentable natural options,” he said.

“This often creates a difficult line between what is considered simply reporting on a research study result versus what is considered making a promotional product claim to treat a disease, even if the report is based on solid research.”

Teitelbaum vowed to keep advocating “for consumer access to truthful, reliable, information about the thousands of studies demonstrating the health benefits of natural dietary supplements and herbal products, while ensuring the language on the web site complies with FDA regulations.”

Still, after reading the warning letter, you could almost hear a collective sigh by agency staff. “The unlawful disease treatment and prevention claims made on your website were too numerous to list in this letter,” wrote Evelyn Bonnin, District Director of the FDA’s Baltimore District Office.

The FDA listed the following dietary supplements as being marketed as unapproved drugs but also noted the list was only a fraction of the violations.

Corvalen (D-Ribose)
Coenzyme Q10
Jigsaw Magnesium w/ SRT
BMR Complex (Thyroid Glandular)
Energy Revitalization System
Acetyl-L-Carnitine
Chol-less
Thymic Protein
Alpha Lipoic acid
Black Cohosh
Healthy Knees and Joints
Eskimo 3 Fish Oil

FDA approves Pfizer drug Inlyta for advanced kidney cancer

Renal cell carcinoma is a kind of kidney cancer that begins in the lining of extremely small tubes in the kidney. More recently, the US Food and Drug Administration (FDA) has approved the drug namely Inlyta for the treatment of patients suffering from advanced kidney cancer who are non-responsive to other medications for this cancer.

To test the working and safety of the drug, a randomized trial constituting nearly 723 patients whose condition had advanced and were exposed to 1 prior systematic therapy, was conducted. The team wished to examine if the drug helped in progression free survival, which is the period when the disease does not progress and the patient is alive.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005. Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options,” commented Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

While a standard treatment using a sorafenib resulted in 4.7 months progression free survival, Inlyta apparently showed 6.7 months progression-free survival. The common side-effects seen were high blood pressure, loss of voice, poor appetite, hand-foot syndrome, diarrhea, weakness, nausea, vomiting, weight loss, tiredness and constipation.

As a word of caution, the team has urged patients to control high blood pressure prior to consuming Inlyta. Notably, patients with gastrointestinal bleeding and untreated brain tumors should not consume this drug. Some of the individuals who took the medication also seemed to encounter bleeding problems that turned fatal in some cases.

Inlyta is a tablet that is supposed to be taken 2 times in a day. It is marketed by Pfizer.

source: healthjockey

FDA approves non-invasive heart valve

Federal health officials have approved a first-of-a-kind artificial heart valve that can be implanted without major surgery, offering a new treatment option for patients who are too old or frail for the chest-cracking procedure currently used.

The Food and Drug Administration said late Wednesday it approved Edwards Lifesciences' Sapien heart valve, which can be threaded into place through a major artery that runs from the leg up to the heart. Cardiologists say the highly anticipated new approach will help old, sickly patients who cannot undergo the more invasive open heart surgery, which has been used to replace valves for decades.

Other companies have won approval for less-invasive heart valves before, but Edwards' implant is the first replacement for the aortic valve, the heart's main doorway.

About 300,000 U.S. patients suffer from deterioration of the valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA.

Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Mayo Clinic's Dr. David Holmes said the Sapien valve is a "game changer" for those inoperable patients, many of whom are in their 80s with medical conditions like diabetes, emphysema and liver disease.

"We don't have very good therapy for them at this time — some of them receive palliative care and some receive medication," said Holmes, who is president of the American College of Cardiology. "But this is really a mechanical problem, and for mechanical problems medications don't work very well."

Edwards' transcatheter valve is threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

FDA based its approval on a 365-patient study that compared outcomes for patients with the valve and those who received basic comfort care and other non-surgical treatment. After one year, 70 percent of patients with the valve were still alive, compared with only 50 percent of those who received alternatives. However, the device was associated with serious complications, including stroke and internal bleeding. Under the conditions of FDA approval, Edwards will track the medical history of all patients who receive the valve.

The device is only approved for patients who cannot undergo open-heart surgery.

About 20,000 new U.S. patients will be eligible to receive a heart valve each year based on Wednesday's approval, according to Morgan Keegan analyst Jan Wald.

The larger opportunity for the new valve is in patients who are healthy enough to undergo surgery, but are considered high-risk and could benefit from a less invasive procedure. The FDA is expected to clear the device for those patients next year, and analysts estimate that group could eventually number between 50,000 and 80,000 annually as the U.S. population ages.

Edwards is expected to charge about $30,000 for the valve, though hospital fees could bring the total cost of surgery closer to $70,000. Standard heart valve replacement costs upward of $50,000, mostly from surgical and hospitalization fees.

The approval represents a dramatic business opportunity for Irvine, Calif.-based Edwards Lifesciences Corp., which had total sales of $1.5 billion last year. Analysts estimate that sales of the Sapien valve could help double the company's revenue to $3 billion within a decade. Company shares rose $3.11, or 4.2 percent, to $77.48 in after-hours trading.

The company expects to train surgeons at 150 to 250 sites across the U.S. to implant the Sapien in the coming year.

The valve has already been approved for four years in 40 countries around the world, including most of Europe. In most of those countries Edwards already sells a next-generation version of the device.

source: msnbc

FDA: Cancer drug shortages getting worse

Since 2010, the number of drugs either in short supply or not available at all has risen dramatically, according to the U.S. Food and Drug Administration.

Most of these are generic drugs given by injection and used in hospitals to treat serious conditions such as breast and testicular cancer. These shortages are putting patients at risk and compromising their care, experts say.

"FDA has been monitoring shortages for the last six years, and in 2010 we saw a large spike in shortages, which was a large jump from the year before," said Valerie Jensen, associate director of the Drug Shortage Program in FDA's Center for Drug Evaluation and Research. "That's what we are continuing to see in 2011. We are still seeing these large numbers of injectable drug shortages."

Dr. Richard Schilsky, past president of the American Society of Clinical Oncology, said "this is very serious, particularly the shortage of cancer drugs."

"Patients are being called everyday by their oncologist being told that they have to delay their treatment because the drug isn't available," Schilsky noted. "We have had to set priority lists of which patients are going to get treatment, because we don't always have an adequate drug supply. And it varies week-to-week; sometimes day-to-day."

There are several reasons for these ongoing shortages, Jensen said. Most are due to problems in manufacturing, ranging from contamination to late delivery of raw materials. Other problems include misprints in the drug's label or packaging and increased demand, she said.

Some people believe the FDA is causing part of the problem by not quickly inspecting plants to allow them to start producing the drug again, but Jensen challenged that notion.

"If the company is having a quality issue, the company doesn't have to wait for an FDA inspection to restart the manufacture," Jensen explained. The agency attempts to work with the companies to get drugs back into the market or tries to locate other sources for these drugs, she added.

However, Jensen noted that since most of these drugs are generic, companies don't make much money on them and may, in some cases, opt to discontinue them.

Joseph M. Hill, director of federal legislative affairs at the American Society of Health-System Pharmacists, said that, "from our members' perspective, it is kind of a crisis."

"We are seeing a shortage of critical drugs in the areas of cancer therapy, pain medications, including anesthetics, and some nutritional products. Some of these are products that people cannot do without," he said.

Another reason for the shortages, may be that companies are using them to increase prices, Dr. Otis Brawley, chief medical officer at the American Cancer Society, said.

"There is a pattern here. The drugs for which there is a shortage are the generic drugs, where the ability to make money is not as great," he said. "If the drug is off the market, they can reprice it."

While many of these delays are due to real manufacturing problems, "there are instances where I am certain that manufacture was stopped because they wanted to raise the price," Brawley said.

However, David Belian, a spokesman for the Generic Pharmaceutical Association, said that companies are not taking drugs off the market to raise prices.

"Shortages have been caused by everything from an insufficient supply of available raw materials to meet demand, to inadequate and delayed communications about shortages, both within the supply chain and also within and among the FDA's enforcement and drug shortages personnel," he said.

"FDA enforcement actions that delay or deter the production of certain products have also had an impact, as have changes in clinical practices that have altered volume production and use, as well as wholesaler stockpiling of critical medications," Belian said.

There are about a dozen commonly used cancer drugs that have been in and out of short supply for a year, Schilsky said. These include Doxil (doxorubicin), which is made exclusively by Janssen Products LP and used off-label to treat breast cancer.

"For some drugs there may be alternatives, but for some diseases there are not good substitutes," Schilsky said. "Some of these drugs are lifesaving drugs for patients. There is the potential that this could result in bad outcomes."

Another example of a drug that is in short supply is the leukemia drug cytarabine, where three makers of the drug are all experiencing delays.

"This is one of the bedrock treatments for acute leukemia and there is no suitable substitute for that," Schilsky said. "Patients with leukemia are patients who can't wait, they need treatment and they need it now."

Another chemotherapy drug, cisplatin, which is essential in the treatment of testicular cancer, is also in short supply. While the drug can be substituted in some disease, for testicular cancer it is the "curative therapy and the best possible therapy," Schilsky said. "Patients' lives are on the line here."

source: yourlife.usatoday

US FDA Issues Draft Regulatory Guidelines For Mobile Medical Apps

With the increasing number of medical and health care related apps making their way on smart phones and other portable devices (tablets, media players etc), the US Food and Drug Administration has issued Draft Guidances for bringing certain Mobile Medical Apps into the regulatory regime, seeking feedback from the medical industry and the FDA Staff.

This is a sign of things to come – with an increased focus on mobile health related services in India, undoubtedly, mobile initiatives in India will also come under regulatory scrutiny. Regulators in the country are waking up to the impact of digitization: for example, the insurance regulator IRDA issued draft guidelines regarding web aggregators of insurance services earlier this year. The guidelines from the US FDA for medical mobile apps should be seen as a pointer for something that might happen in India, perhaps a couple of years from today (if not sooner):

What The US FDA Is Seeking To Regulate

The guidelines cover only select apps that are critical to or impact the performance or functionality of currently regulated medical devices, and app developers whose apps qualify as a medical app as per the FDA’s definition, would be under close watch of the authority. App distribution platforms such as app stores are expected to cooperate with app developers in conducting corrections and removals. Although the draft guidance does not establish legally enforceable responsibilities, it does require the manufacturers i.e developers to annually register their establishments with the FDA and provide a list of devices/apps they market, so that it is informed about them.

The FDA believes that this subset of mobile apps poses the same or similar potential risk to the public health as currently regulated devices, if they fail to function as intended.

More Information

FDA warns of risk of anemia drugs

Medications given to treat anemia in kidney and cancer patients greatly increase the risk of cardiovascular problems and need to be used more conservatively, the Food and Drug Administration has said.

The medicines, known as Erythropoiesis-Stimulating Agents (ESA) are approved to treat anemia resulting from Chronic Kidney Disease, chemotherapy and other conditions. But clinical trials have showed an increased risk of heart attacks, thrombosis and strokes when the drugs are given at high enough levels to get a normal blood hemoglobin level. Additionally, ESAs also do not improve quality of life, fatigue or patient well-being, the FDA stated Friday.

“Healthcare practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risks,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. “The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”

In addition to the side effects, critics charge that these medicines were the single biggest drug expense in the federal Medicare program, costing the federal government more than $60 billion since they debuted in 1989, The New York Times reported. “Sixty billion dollars have gone out the window on these drugs, and what do we have to show for it?” Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit health policy research institute in Bethesda, MD, asked rhetorically in The Times.

FDA Warns Chantix May Trigger Heart Diseases

The Food and Drug Administration has announced that the risk of heart disease and other heart-related conditions may increase if an individual is smoking cigarettes; preventing and quitting such habit will most probably lessen the risk. But the agency noted that if you are using Chantix, a drug that helps smokers to quit the routine, it could be linked to a small risk of having heart-related diseases.

For the evaluation, experts looked at data from a population of 700 patients who have been identified with heart disease. This group of people was divided into two; one was assigned to take Chantix for a period of 12 weeks and the other took only placebo. The findings showed that those who took Chantix were more likely to go through heart-related conditions after one year compared to those who had placebo. On a lighter note, heart attack risks are significantly small – 3 patients out of 350 who had placebo while 7 who had Chantix.

Moreover, the FDA recommends patients who took the drug to visit their doctors. This is to verify if the patient has a worsening or new indication of heart disease, including chest pain, pain when walking or difficulty in breathing.

In addition, Chantrix was also notified to be connected in the increased risk of suicidal behaviors, not just heart diseases.

Diabetes Drug Might Raise Cancer Risk - FDA

The U.S. Food and Drug Administration is warning consumers that the popular diabetes drug Actos (pioglitazone) may increase the risk of bladder cancer when used for more than a year.

The agency's warning comes five days after Germany and France pulled Actos from the market, citing similar concerns. Actos is in a class of drugs called thiazolidinediones, the only other member of which, Avandia (rosiglitazone), was taken off U.S. pharmacy shelves in May because it was linked to an increased risk of heart attacks.

The new cancer warning will appear on the labeling, the FDA said.

However, although Actos does have some side effects, "the beneficial effects of Actos, I think, outweigh any possible risk of cancer," said Dr. Joseph Giangola, medical director of diabetes at Hackensack University Medical Center in Hackensack, N.J.

Actos is used to control blood sugar and is sold alone or in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). In 2010, more than 2 million patients were taking these drugs, according to the FDA.

The new warning is based on FDA's review of data from an ongoing study, which found that Actos increased the risk of bladder cancer among patients taking the drug over a long period at the highest doses.

In one study involving more than 193,000 patients with diabetes, patients taking Actos were on the drug for an average of two years, the FDA said. "Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer]," the agency said.

In addition, the agency says it is aware of the French study that caused France to pull the drug. That study showed a dose-response effect, where risks for bladder cancer rose as time spent taking Actos lengthened past one year.

Right now, the FDA is advising doctors not to use Actos in patients with bladder cancer and to use it with caution in patients who have had bladder cancer. In addition, the agency says that "the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence."

The agency said diabetes patients should also tell their doctor if they are having symptoms of bladder cancer such as blood or red color in urine, an urgent need to urinate or pain while urinating and pain in back or lower abdomen.

In addition, patients should talk to their doctor about any concerns they have about Actos, the FDA noted.

For his part, Giangola said he is cautious when prescribing Actos. "We try to select the most insulin-resistant people to give Actos to," he said. "Those people do well with Actos."

But if Actos was taken off the market, there would be nothing to replace it, Giangola said. With Avandia essentially gone, "there is no medicine that directly influences insulin resistance the way Actos does," he said.

Giangola added that patients should not be overly concerned right now. "To jump now when we have only one medication in this class would be rash," he said. "They really ought to wait until there is more definitive evidence."

"What's worse -- the theoretical risk [of cancer] or the well-known risk of letting your blood sugar remain high? I say it's clearly [the risk of] letting your blood sugar run higher," Giangola said.

In a statement, Takeda Pharmaceuticals North America Inc., the maker of Actos, said it remains positive about the drug.

The company said in a statement that it is "confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. The company remains committed to Actos and Actos-containing medications, and to the millions of people living with the disease."

source: news.yahoo

FDA declares new labeling norms for sunscreen

Avoiding painful sunburn and deadly skin cancer should get easier next summer.

The U.S. Food and Drug Administration announced new requirements Tuesday for sunscreen labels that officials hope will provide simpler but more thorough information on how to avoid sunburn, skin cancer, and the wrinkles of aging.

By next summer, the FDA suggests, be wary of any product that has an SPF number above 50. And regardless of the label, wear a hat.

"I think this is great," said Thomas Jefferson University Hospital's Steven Greenbaum, a third-generation dermatologist. "You had companies going wild and trying to outdo each other with SPFs of 80 or 100. There's never been any evidence to show that above a certain level it offers more protection."

SPF stands for Sun Protection Factor, which will still be used. But many people guessed - wrongly - that a sunscreen with SPF 30 was twice as protective as one with SPF 15. There is only an incremental difference. The new limit will be 50, though the FDA set up a plan to allow manufacturers to do clinical studies to prove that a mixture could warrant a higher figure on the label.

The FDA will now test for protection against ultraviolet A (UVA) and ultraviolet B (UVB) rays, with those passing both tests being labeled "broad spectrum." Both types of rays contribute to sunburn, skin cancer, and premature skin aging. Sunburn is mainly caused by UVB rays.

Products with SPF values between 2 and 14 may be labeled as broad spectrum if they pass the required test, but only products that are labeled "broad spectrum" and have SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. Those products not meeting both standards will need a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

An estimated 3.5 million new cases of skin cancer are diagnosed each year.

"My entire practice is devoted to removing skin cancer and reconstructing afterward," said Joseph Sobanko, an assistant professor and dermatologic surgeon at the Hospital of the University of Pennsylvania. "Every week, a number of patients say, 'I wish that I knew years ago how the sun would damage my skin.' "

Staying out of the sun at the hottest times (10 a.m. to 2 p.m.) and wearing hats and more clothes still matter in helping to avoid sunburn and cancer.

The sunscreen industry reacted to the proposed new requirements and labeling.

"Coppertone welcomes the FDA's new sunscreen-labeling rules and supports efforts that make it easier for people to choose sun protection for themselves and their families," Merck & Co. Inc., the maker of Coppertone, said in a statement.

Johnson & Johnson markets the Neutrogena and Aveeno sunscreen products, but the company differed with the FDA on the value of sunscreens beyond SPF 50.

"While we support the FDA's efforts, we continue to believe that SPF products over 50 provide additional sun protection for consumers and we have submitted data in support of our position," Johnson & Johnson said in a statement. "We believe that limiting labeling for SPF values higher than 50 may deter consumers from receiving the highest levels of sun protection."

Highlights of the FDA's New Rules

SPF: Sun Protection Factor. Without proof, the new limit will be 50.

SPF math: A product with an SPF of 15 gives a person 15 times more protection from ultraviolet B rays than someone wearing nothing. A higher number will give longer protection but not necessarily more protection.

Broad spectrum: Labels can use the term if the product also meets FDA testing rules for ultraviolet A light rays, which contribute to cancer and aging wrinkles.

Waterproof? Sunscreens on the market are NOT waterproof or sweat proof. New labels will say how water resistant the product is.

Advice: Read the label, apply early and often. Stay out of the sun between 10 a.m. and 2 p.m.

source: philly

FDA approves new test for intestinal superbug

A new test is available that can rapidly detect Clostridium difficile and the presence of toxin B gene, a strain of bacteria that causes diarrhea, colitis and in some cases, severe intestinal conditions that can result in death.

Cepheid Xpert C. difficile/Epi assay can help clinicians determine if C. difficile is present in a patient's stool, but also if the bacteria is of the epidemic 027/NAP1/BI strain, known for its increased prevalence and hypervirulence.

“Health care professionals in the infectious disease community who have seen various outbreaks of C. difficile-associated infections with aggressive strains in recent years now have a new testing tool to detect this disease,” Alberto Gutierrez, PhD, the director of the Office of In Vitro Diagnostics Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health, said in a press release.

Those at highest risk of developing C. difficile infection include the elderly, patients in hospitals or those that live in a nursing home and people who are taking an antibiotic for another infection.

FDA encourages clinicians to monitor the number of C. difficile infections at their health care facility, particularly if the rate of disease increases or patient outcomes worsen.

source: clinicaladvisor

Melanoma skin cancer treatment approved by FDA

Yervoy (ipilimumab) which is marketed by New York City-based Bristol-Myers Squibb gained the US Food and Drug (FDA) approval for treatment of late-stage metastatic melanoma skin cancer. Melanoma is the deadliest form of skin cancer according to the National Cancer Institute. In 2010, there were around 8,700 people that died from melanoma skin cancer.

Yervoy is the first therapy treatment to show that it has extended the life of people diagnosed with last-stage melanoma and to be approved by the FDA. The Yervoy drug treatment is given intravenously.

The trial study found that melanoma patients taking Yervoy along with an experimental tumor vaccine gp100 had lived an average of 10 months, while the group that received only the experimental tumor vaccine lived an average of 6.5 months.

Side effects of Yervoy reported were fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). There were patients that suffered severe to fatal autoimmune reactions in 12.0 percent who received Yervoy. The treatments were stopped for those melanoma patients during the study. It took several weeks for the patients that did respond to the Yervoy treatment to see improvements.

BY: N Wilson

FDA Panel Urges Caution on Genetic Test Kits

Advisory Panel Is Wary of Genetic Testing That Is Sold Directly to Consumers

An FDA advisory panel has urged federal regulators to go slowly in allowing companies to sell genetic testing kits directly to consumers, amid worries that test results could be easily misinterpreted.

The panel recommended that the FDA require sign-off from medical professionals either for ordering most tests or for interpreting the results. That would mean that tests for many diseases or conditions -- and delivery of results -- would not be available without what amounts to a prescription.

The FDA doesn’t have to follow the recommendations of its advisory panels, but often does.

The vast majority of genetic tests are available only through doctors or genetic testing centers, while results are generally interpreted by doctors and a relatively new industry of genetic counselors.

But a cottage industry of direct-to-consumer testing companies sprang up in recent years. The industry recently caught the eye of regulators, who essentially warned several companies that their tests were not able to predict health conditions as reliably as advertised.

The FDA has since decided to more closely police the industry and is deciding what kinds of tests deserve closer control and which ones could still be available direct-to-consumer (DTC).

“A lot of us feel that these tests are not going to be safe enough to be in DTC,” says George Netto, MD, an associate professor and prostate cancer researcher at the Johns Hopkins University School of Medicine and a member of the panel.

Genetic Role in Disease

It is rare for a genetic mutation to cause a condition directly, as it does in Huntington’s disease. In most cases the link between mutations and disease depend on complex interactions between many mutations, environmental factors like diet, and interactions with other health conditions.

For example, several gene mutations are known to increase the risk for hypertension. But having the mutation does not necessarily lead to hypertension, and factors including exercise, smoking, fatty food, and stress also play important roles. At the same time, having hypertension is a risk factor for cardiovascular disease but is itself intertwined with other causes.

How can a consumer determine whether a positive test actually increases their risk of dying from a heart attack?

At the heart of the FDA’s dilemma is how to balance patients’ rights to information about their risks for disease with the need to have professionals involved in the interpretation of results that can cause consumers to worry or to seek out medical care.

“Medical students don’t understand it and practicing docs don’t understand it,” says David Rahsohoff, MD, an epidemiologist from Yale University and a member of the panel. “We certainly can’t expect consumers to do that.”

But companies warned that aggressive regulation would stifle patients’ ability to improve their health by dealing with known health risks. Just because the connections between many gene mutations and disease are poorly understood doesn’t mean patients should not have access to tests, says Mary K. Pendergast, a board member of the drug company AesRx.

We can’t live our lives where we can’t know anything until everything is known,” said Pendergast, a lawyer and industry consultant who served for seven years as FDA’s deputy commissioner.

Last year, FDA scrutiny prompted Walgreens to pull back on a decision to sell genetic testing kits from a company called Pathway Genomics.

Ed MacBean, the company’s vice president of product management, acknowledged his company had “treaded into” an uncertain business situation, given the FDA’s move.

Other companies, like 23andMe, offer consumers genetic testing kits directly to consumers over the Internet. The company’s web site promises consumers insight into traits from baldness to muscle performance and the chance to “discover risk factors for 95 diseases” for $199.

The company was founded by Anne Wojcicki, wife of Google co-founder Sergey Brin.

Alberto Guttierez, PhD, director of the FDA’s office of in vitro diagnostics, says the agency would look at tests on a case-by-case basis to decide if they should be available directly to consumers.

Tests for genes that affect prescription drug metabolism are likely to remain restricted since the drugs themselves can only be obtained under a doctor’s care. But other tests helping predict metabolism of certain foods would probably have fewer safety implications and may enjoy easier sales for companies.

“It’s going to depend on the test and what they want to claim and how it’s offered,” he told reporters.

The agency will look at the quality of scientific data connecting a test to the disease it’s supposed to predict and at “whether people can understand it and do something with it or not,” Guttierez says.

source: webmd

FDA approves in-home use of ventilation assistance technology

A new tool has received clearance from the U.S. Food and Drug Administration to be used in patients' homes, where it is meant to aid disease management efforts for those with respiratory conditions. The device, called the Breathe Technologies BT-V2S ventilator, aims to assist individuals who have illnesses such as chronic obstructive pulmonary disease (COPD).

"This marks an important milestone for the future of COPD disease management and patient quality of life," said the manufacturer's president and CEO, Larry Mastrovich. "Patients with advanced COPD frequently suffer a loss of mobility, which may accelerate their respiratory disease progression and lead to decreased functional abilities."

He added that this type of healthcare management technology can help patients at home because it has the potential to improve their ability to perform daily tasks.

According to chairman John Miclot, the company is focusing on getting the device out onto the market so that patients who require ventilation assistance can benefit as soon as possible.

Such technology is becoming more commonly used in the field of healthcare, where it has been shown to not only improve disease management, but also to improve patient outcomes, reduce diagnostic errors, cut costs and save time.

source: medecision

About Breathe Technologies

Breathe Technologies, Inc., located in San Ramon, California, is a developer and manufacturer of innovative medical technologies for treating lung diseases and sleep-disordered breathing. The company was founded in January 2005, and their ventilator, featuring the company's proprietary, open-airway platform, is cleared for use in both the institutional and homecare settings.

CONTACT: Rebecca Mabry of Breathe Technologies, +1-925-359-1506, beckym@breathetechnologies.com

Precautions to take when using eye cosmetics: FDA Advice

What precautions should you take when using eye cosmetics?

If you use eye cosmetics, FDA urges you to follow these safety tips:

* If any eye cosmetic causes irritation, stop using it immediately. If irritation persists, see a doctor.

* Avoid using eye cosmetics if you have an eye infection or the skin around the eye is inflamed. Wait until the area is healed. Discard any eye cosmetics you were using when you got the infection.

* Be aware that there are bacteria on your hands that, if placed in the eye, could cause infections. Wash your hands before applying eye cosmetics.

* Make sure that any instrument you place in the eye area is clean.

* Don't share your cosmetics. Another person's bacteria may be hazardous to you.

* Don't allow cosmetics to become covered with dust or contaminated with dirt or soil. Keep containers clean.

* Don't use old containers of eye cosmetics. Discard mascara three months after purchase.

* Discard dried-up mascara. Don't add saliva or water to moisten it. The bacteria from your mouth may grow in the mascara and cause infection. Adding water may introduce bacteria and will dilute the preservative that is intended to protect against microbial growth.

* Don't store cosmetics at temperatures above 85 degrees F. Cosmetics held for long periods in hot cars, for example, are more susceptible to deterioration of the preservative.

* When applying or removing eye cosmetics, be careful not to scratch the eyeball or other sensitive area. Never apply or remove eye cosmetics in a moving vehicle.

* Don't use any cosmetics near your eyes unless they are intended specifically for that use. For instance, don't use a lip liner as an eye liner. You may be exposing your eyes to contamination from your mouth, or to color additives that are not approved for use in the area of the eye.

* Avoid color additives that are not approved for use in the area of the eye, such as "permanent" eyelash tints and kohl. Be especially careful to keep kohl away from children, since reports have linked it to lead poisoning.

source: FDA

FDA Comes Down on Chelation as Untested Autism Treatment

Chelation is a legitimate medical treatment for heavy metal poisoning, but there's no evidence that it treats autism, heart disease, Alzheimer's, and other serious conditions. Despite that, chelation is heavily marketed on the Internet and by "alternative" physicians and pharmacists as a cure. The U.S. Food and Drug Administration just slapped the hands of eight companies for marketing chelation as a medical treatment for autism, saying that the treatments could be dangerous, and could also keep people from using therapies that are safe and effective.
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"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a press release. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief."

Chelation chemicals are approved for treating poisoning with lead and other heavy metals; they bind to the metals in the body, and are then excreted in urine. But chelation chemicals also can cause serious harm, including kidney failure and death. In 2005, a 5-year-old boy died of a heart attack while being treated with chelation for autism by a Pennsylvania physician. The physician was sued by the child's parents, and his medical license was suspended for three years.

And there's no evidence that chelation even works for autism; the treatment is based on the unproven theory that children with autism have heavy-metal poisoning. A 2008 study that evaluated the quality of research on various autism treatments gave chelation the lowest possible grade, saying there are no controlled trials on the safety and effectiveness of chelation as an autism treatment. (Behavioral therapies like applied behavior analysis are considered the best-researched option for treating autism.) That same year, the National Institutes of Health canceled plans to run a clinical trial on chelation for the treatment of autism in children, saying the risks outweighed any potential benefit.

There are many "success" stories about treating autism with chelation on the Internet. They are heartwarming, but don't provide reliable evidence because they are reported either by parents eager to see improvement in a beloved child, or by practitioners selling the treatments.

The NIH is continuing with a $30 million trial of chelation as a treatment for coronary artery disease in adults, a large study with 1,600 participants. (Clinical trials for adults are held to less stringent safety standards than are those for children.) Proponents of chelation for heart disease say the chemical binds to calcium in arterial plaque, sweeping away the plaque and opening vessels. But there's no evidence that happens. Results of that trial are expected in 2012. That study won't provide much-needed evidence on the safety and effectiveness of chelation for autism, but it may help parents make better-informed decisions on their children's care.

source: health.usnews

FDA cracks down on experimental autism therapy

Federal health officials are cracking down on a controversial therapy that has been promoted as an alternative for a variety of conditions, including autism, Alzheimer's disease and Parkinson's disease.

The Food and Drug Administration warned eight companies Thursday that their over-the-counter products used for a procedure known as "chelation" are "unapproved drugs and devices" and so are in "violation of federal law."

"The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson's disease, Alzheimer's disease, macular degeneration and other serious conditions," the agency said. "Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy."

The drugs involved have not been evaluated by the FDA for treatment of these diseases, and therefore violate the Federal Food, Drug and Cosmetic Act, the FDA said.

"Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care," the FDA said.

The drug can have serious safety risks, the agency said, because the agents can "alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death," the FDA said.

"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," said Deborah Autor, director of the FDA's office of compliance in center for drug Evaluation and research. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief."

The agency advised consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available only by prescription and approved for use in specific indications such as lead poisoning and iron overload.

The FDA took the action after noticing "an increase in 'chelation therapy' products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease," the FDA said. "The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths."

"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness," said Dara A. Corrigan, associate commissioner for regulatory affairs.

The companies that received the warning letters are:

-- World Health Products, LLC
-- Hormonal Health, LLC and World Health Products, LLC
-- Evenbetternow, LLC
-- Maxam Nutraceutics/Maxam Laboratories
-- Cardio Renew, Inc.
-- Artery Health Institute, LLC
-- Dr. Rhonda Henry

The 2007 National Health Interview Survey, conducted by the Centers for Disease Control and Prevention, found that 111,000 adults 18 and older used chelation therapy in the previous 12 months.

The National Institutes of Health is sponsoring a large study to test whether the chelation agent EDTA is safe and effective for people 50 and over with heart disease. EDTA stands for ethylene diamine tetra-acetic acid, which is a synthetic amino acid that is delivered intravenously. The treatment is not approved for heart disease, but some doctors are using it. The results are expected in 2012.

The theory is that EDTA chelation might work by directly removing calcium found in fatty plaques that block arteries, causing the plaques to break up, that the process may stimulate the release of a hormone that in turn causes calcium to be removed from the plaques or causes a lowering of cholesterol levels. Another theory is it may reduce the damaging effects of oxygen ions (oxidative stress) on the walls of the blood vessels. Reducing oxidative stress could reduce inflammation in the arteries and improve blood vessel function. None of these theories has been well tested in scientific studies.

source: voices.washingtonpost

FDA Warning: 600,000 Avandia Users in the US Risk Heart Attacks, Stroke or Heart Failure

About 600,000 users of the controversial diabetes drug Avandia (rosiglitazone) are exposing themselves to possible heart attacks, strokes or heart failures. The US Food and Drug Administration (US FDA) has issued severe restrictions on the use of the drug manufactured by GlaxoSmithKline (GSK) because of the heart health risks.

Rosiglitazone is currently being taken by patients with Type 2 diabetes. Avandia is taken as a stand-alone medication or in combination with metformin (Avandamet) or with glimepiride (Avandaryl). It was the research of Cleveland cardiologist Dr. Steven Nissen which established a strong linkage between heart ailments and the use of the drug.

The US FDA’s restrictions on Avandia are as follows:

* GlaxoSmithKline (NYSE:GSK), the drug’s manufacturer, is restricted from promoting the drug. Individuals currently taking the drug will be advised to transfer to another similar medication
* Doctors cannot prescribe the diabetes drug to new patients without giving them detailed explanation on the risks involved.

GlaxoSmithKline (GSK) was also advised by the US FDA to to convene an independent group of scientists to re-check data on the drug’s clinical trials, USA Today reported earlier.

While Avandia is still available in the US, the European Union’s European Medicines Agency has altogether banned the sale of the GSK diabetes drug because of its record in clinical trials.

It is estimated that in the US more than 47,000 Avandia users suffered from a heart attack, stroke or heart failure during the period 1999 to 2009. Dr. Nissen said the FDA’s decision brought an end to “one of the worst drug safety tragedies in our lifetime.” He added that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”

Avandia was once the best selling diabetes drug in the market. In 2009 its sales went down to $1.2 billion from $3.2 billion in 2006 because of its risks to heart attacks and other heart ailments.

source: all247news