FDA will reveal on Friday the data it is reviewing ahead of an advisory panel meeting about the safety of the popular diabetes drug.

The meeting, scheduled for July 13 and 14, comes on the heels of two new studies suggesting that Avandia may cause serious or even life-threatening heart problems — and a third study that seems to show just the opposite.

In type 2 diabetes, the body loses the capacity to metabolize glucose — sugar — in the blood. High blood sugar can lead to severe complications. Avandia was approved in 1999 after trials by GlaxoSmithKline (then known as SmithKline Beecham) showed that it could lower blood sugar, by improving the body’s own ability to process glucose.

The tide turned in June 2007, when Dr. Steven Nissen, a respected heart expert at the Cleveland Clinic, published a meta-analysis — a paper looking at all the available research on Avandia — and concluded that the drug not only failed to prevent heart disease in diabetics, but actually raised the risk of heart failure and increased the risk of heart attacks by 43 percent.

Confusion and controversy ensued, along with scrambling on the part of Glaxo. In a series of meetings, e-mails and public statements — detailed in a Senate report released in February — GlaxoSmithKline fought to clear the name of its popular drug. There were allegations of pressure, both public and private, on researchers. And there was the expedited publication of a major clinical trial known as the RECORD study, which compared Avandia with two older diabetes drugs — metformin and sulfonylurea — and found no link to heart problems. A more complete version of theresults was made public last year.

RECORD, however, did not include enough patients — or find enough heart problems — to reach a definite conclusion. Critics, unmollified, accused Glaxo of putting business goals ahead of good science. The Senate report cited internal company documents and dismissed the RECORD study as a marketing tool “to limit competition from Actos,” a competitor’s drug.

A spokeswoman for GlaxoSmithKline says the company welcomes a full airing of the evidence. Dr. Murray Stewart, vice president of clinical development, said in a phone interview that the FDA will need to consider the “totality” of evidence, not just the meta-analyses. According to Stewart, “All the clinical trials show no increase in mortality” when Avandia is compared with other drugs.

A closer look reveals that concerns similar to those raised by Nissen date back to the 1990s. In 2000, the advocacy group Public Citizen successfully petitioned the FDA for a stronger warning label, based on studies in animals before the drug was approved.

Nissen said the FDA should have acted long ago. “There are no unique benefits for this drug that are not provided by other diabetes medications,” he said in a phone interview last week. “I want the FDA to order the company to withdraw the drug. The evidence is there, and it’s been there a long time. It’s a matter of having the political will to do it.”

The FDA would not comment prior to its document release, but such sweeping statements anger Dr. Alan Garber, a diabetes specialist at the Baylor College of Medicine in Houston. Garber has been an investigator on two major clinical trials of Avandia, with funding from GlaxoSmithKline, as well as from the National Institutes of Health and other sources. He says neither study found an increase in heart attacks, although he agrees that patients with heart failure should not take Avandia. Garber says those trials, along with the RECORD study, offer good evidence that Avandia is effective as well as safe for most patients.

“This drug offers the most durable glucose control of anything,” he said. “The more you reduce glucose, the more you reduce the eye disease, the kidney disease and the neuropathic complications.”

In clinical trials, patients on Avandia show a smaller rise in fasting glucose levels — a standard measuring stick for diabetes — than patients taking other drugs. In theory, as Garber points out, this should be good news for patients on Avandia. Critics, though, say there is no evidence of better long-term outcomes — lower mortality or fewer complications.

Garber sits on the board of the American Association of Clinical Endocrinologists. He says the clinical trials — which closely followed several thousand patients, under careful monitoring — constitute a gold standard of evidence for the FDA, compared with broad but less detailed data used in studies such as Nissen’s.

“If there is a [negative] effect, it’s a small effect,” says Garber. “Let’s treat our patients instead of sensationalizing half-truths and conclusions that are not yet formed. Otherwise what happens is that patients stop taking their medicines. I’ve seen data, and a fair number of patients just stop taking medicine, and as a result their blood sugar rises. That convincingly demonstrates harm, whereas all these other things are all unproven.”

hree studies made public in late June will add fuel to what was already shaping up as a potentially fiery debate at the FDA. In the Archives of Internal Medicine, Nissen and colleagues published an update of their 2007 paper, including additional studies, and reported a similar increased risk of heart attacks and heart failure. The Journal of the American Medical Association published an analysis by Dr. David Graham, the FDA scientist who first flagged deadly side effects of the painkiller Vioxx. Graham compared Avandia with Actos, and found patients on Avandia are more likely to suffer stroke, heart failure or premature death. At the same time, doctors who support Avandia got ammunition from a presentation at the scientific meeting of the American Diabetes Association. There, Dr. Richard Bach of Washington University presented data from the BARI-2D study, and said it shows patients on Avandia actually have a lower risk of heart attack or stroke.

Practicing physicians find themselves in a quandary. Since 2006, sales of Avandia have fallen by about two-thirds, with many physicians taking the tack of Dr. Barbara Onumah, a diabetes specialist at Washington Hospital Center in the nation’s capital. After the first reports of trouble, she says, patients began coming into the office with news clippings and anxious questions. Since then she has switched all but one of her diabetes patients to different medications.

Onumah says she just wants some clarity. “I’m looking for a strong statement [from the FDA]. Because right now, there’s a lot of information. But none of it is clear.”

After Nissen’s bombshell, the FDA pushed GlaxoSmithKline to launch a major effort to try to settle the safety issue once and for all. Known as the TIDE study, it’s designed to recruit more than 15,000 patients and be completed by 2015. However, barely a thousand patients have been willing to sign up — a shortfall that seems likely to continue in the wake of ongoing doubt and negative reports. An FDA spokeswoman says the fate of the TIDE study will be on the agenda of next week’s meeting.

Source: CNN

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Correctly interpreted, the study actually supports critics’ contentions that Avandia may cause heart attacks, said the reviewer, Dr. Thomas Marciniak, in a posting on the F.D.A.’s Web site.

The company’s misreadings of the study, known as the Record trial, were so profound, he concluded, that they “suggest serious flaws with trial conduct.”

“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks.

The review is part of a broad reassessment of Avandia’s safety by F.D.A. medical officers to educate a panel of experts who will gather next week in Gaithersburg, Md., to advise the agency whether Avandia should be withdrawn from the market — after millions of prescriptions, billions of dollars in sales and 11 years of wide use.

The panel’s decision will have broad repercussions not only for GlaxoSmithKline — which recorded $1.2 billion in Avandia sales last year and could face significant liability if the drug is withdrawn — but also for the F.D.A. The agency has been riven for years by fierce internal disagreements about Avandia’s uncertain risks. It was the F.D.A.’s delay in issuing stronger warnings about Avandia that led Congress in 2007 to give the agency greater powers over drug makers.

GlaxoSmithKline said in a statement that Avandia was safe.

“Since 2007, we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia, and together they show that this medicine does not increase the overall risk of heart attack, stroke, or death,” said Dr. Murray Stewart, the company’s vice president for clinical development.

Avandia helps patients get better control of blood sugar levels, but its known risks are substantial: it can increase the risks of bone fractures and can cause swelling that can leads to heart failure and eye problems. And a number of studies, including some by GlaxoSmithKline, suggest that it could increase the risks of heart attacks, stroke and death.

Within the F.D.A., some officials insist that the evidence is mixed and others say it is strong enough to merit the drug’s withdrawal. An advisory meeting in 2007 concluded that Avandia did increase the risks of heart attack but that it should remain on the market.

In response, Avandia’s sales fell sharply, to $1.2 billion last year from a peak of $3.2 billion in 2006. But while endocrinologists have advised against its use, Avandia remains popular — with nearly two million prescriptions last year.

During that 2007 advisory meeting, the Record trial — specifically designed to assess Avandia’s heart risks — was a significant source of reassurance for Avandia’s supporters. GlaxoSmithKline insisted that the trial had proven that the drug was safe. In a news conference on Thursday, Dr. Janet Woodcock, director of the F.D.A.’s drug center, called the Record trial one of the “most germane because it’s a study of cardiovascular outcomes.”

Avandia’s critics have long asserted that the Record study was both weakly designed and too short to prove anything. And an investigation by the Senate Finance Committee found that GlaxoSmithKline may have improperly influenced the independent experts in charge of the study.

Now, Dr. Marciniak has found that even the study’s underlying data were misinterpreted. Instead of little risk to the heart, the Record study actually hints at substantial risks, Dr. Marciniak concluded.

Along with a host of observational studies concluding that Avandia is riskier than a similar drug — Actos, made by Takeda — the review by Dr. Marciniak could prove crucial, since it seems to kick away one of the final pillars supporting Avandia’s use.

Another issue the expert committee will be asked to resolve is whether a GlaxoSmithKline study being done at the F.D.A.’s request, comparing the safety of Avandia and Actos, is ethical. Some F.D.A. officials argue that the trial must be stopped, because observational studies — which use health records to measure how patients fared while taking a particular drug — have already proved that Avandia is dangerous.

Others within the F.D.A. say that observational studies are not good enough and that a well-controlled “prospective” study, like the one being conducted by GlaxoSmithKline, is the only sure way to answer whether Avandia is truly dangerous.

In a report released Friday, the Institute of Medicine, the nation’s leading medical advisory group, seemed to side with those who have argued that observational studies are adequate. Indeed, the group seemed to describe almost exactly a study of 227,571 Medicare patients conducted by an F.D.A. reviewer and published June 28 in The Journal of the American Medical Association concluding that Avandia increased the risks of stroke, heart failure and death compared to Actos.

The institute concluded that such studies “can sometimes provide higher-quality safety evidence than randomized controlled trials.”

Still, no matter how the experts vote next week, a final decision about Avandia is the responsibility of the F.D.A. commissioner, Dr. Margaret Hamburg, a public health expert who has shown clear signs that she is more concerned about drug risks than her predecessors in the Bush administration. Her decision could reshuffle the balance of power within the agency and is almost certain to influence hundreds of smaller decisions by staff members on scores of other products for years to come.

“F.D.A. is going to make a decision on behalf of the public,” said Dr. Joshua M. Sharfstein, the agency’s principal deputy commissioner, at a news conference on Thursday.

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The drugs in question are called angiotensin-receptor blockers or ARBs,  AT1-receptor antagonists or sartans, are a group of pharmaceuticals which modulate the renin-angiotensin-aldosterone system. Their main use is in hypertension (high blood pressure), diabetic nephropathy (kidney damage due to diabetes) and congestive heart failure.

Researchers at The University Hospitals Case Medical Center in Cleveland, Ohio, reviewed nine existing studies involving ARBs. “We were able to compile data of more than 60,000 patients,” says lead study author Dr. Ilke Sipahi.

Dr. Ilke Sipahi, a heart failure expert,  and a few colleagues decided to analyze the published data about this class of drugs because several studies from  the past few years suggested an increased cancer risk, and millions of people in the United States and around the world are taking these drugs.

He says their analysis found a 1.2 percent increased cancer risk for patients taking these drugs over four years. Dr. Sipahi says the current data suggest an “overall 10 percent increase in the risk of cancer diagnosis in patients on ARBs compared to placebo.” The study also concludes that the risk for lung cancer was the highest. However, the study authors could not explain why these drugs might be causing cancer.

In an accompanying editorial, Dr. Steven Nissen,  chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, suggests the results of this analysis require urgent regulatory review.

Dr. Nicholas Vogelzang, an expert on several cancers and spokesman for the American Society of Clinical Oncology disagrees. He says he’s fairly skeptical about the study conclusion because the only statistically significant rise was in lung cancer and “there’s no direct mechanism to lung cancer should go up, but breast cancer went down.  He adds that most cancers take 40 years to develop. “ARBs were not even on the market before 1995,” says Vogelzang. “This gives me some pause.”

The American Cancer Society’s Dr. Michael Thun raises the same concern. “If the drugs caused this, then the increased cancer risk appeared much more quickly than is usually the case for solid tumors.”

The American Heart Association’s President Dr. Clyde Yancy actually takes ARBs to control his high blood pressure. He tells CNN in a statement, “These data raise a question, and a question only, regarding ARBs and the risk of cancer. Only non-small cell lung cancer was statistically increased and the extent of the increase was quite modest. We usually describe these kinds of findings as a ’signal’ but given the modest result, perhaps this is more of a ‘hint.’”

Dr. Yancy says the results of this study do not change anything for him – he will continue to take his blood-pressure lowering ARB. Study author Dr. Sipahi says he will continue to prescribe ARBs because for many patients the risk of dying from heart failure outweighs the possible risk of cancer development.

Below is a list of ARBs drugs:

The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores.

How to Recognize the Counterfeit Alli

The counterfeit Alli looks similar to the authentic product, with a few notable differences (see photos). The counterfeit Alli has

• a missing LOT code on the outer cardboard packaging
• an expiration date that includes a MONTH, DAY, and YEAR—the expiration date of the real Alli only contains a MONTH and a YEAR
• a plain foil for the inner safety seal without any words on it—the safety seal of the real Alli has the words “SEALED FOR YOUR PROTECTION” prominently printed on it.
• large capsules with white powder, as opposed to small white pellets found in the real Alli
• a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli

Dangers of Counterfeit Alli

Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version of Alli does not contain orlistat; instead it is made with varying amounts of sibutramine, a stimulant drug.

Although sibutramine is the active ingredient in another FDA-approved prescription weight-loss drug, it is only to be used in specific doses and under the supervision of a physician.

FDA first warned consumers about the counterfeit product on Jan. 18, 2010, based on preliminary laboratory tests that revealed the counterfeit version contained sibutramine and not orlistat. Since that time, FDA lab tests on the counterfeit product show that people may be taking three times the usual daily dose (and twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli.

This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease and can lead to

• elevated blood pressure
• stroke
• heart attack

Even healthy people who take this much sibutramine can experience

• anxiety
• nausea
• heart palpitations
• a racing heart
• insomnia
• small increases in blood pressure

FDA Recommendations

Check to make sure you are not taking counterfeit Alli. If you think you might have the counterfeit product:

• stop taking the drug
• contact your health care professional if you are experiencing more than mild side effects, especially if you have a history of cardiovascular disease
• call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or by visiting the OCI Web site; you may also contact Alli’s maker, GlaxoSmithKline at 800-671-2554

FDA encourages people to report any unexpected side effects that may be related to the use of the counterfeit product to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.

• Online
• Fax: 1-800-FDA-0178

The Justice Department also contends that the company violated the federal anti-kickback statute by making illegal payments to physicians. They were allegedly recruited by AstraZeneca to present themselves as authors of articles the company had written about the drug.

The civil settlement was the latest step in an Obama administration crackdown on health-care fraud. “We will not let such actions stand,” Attorney General Eric H. Holder Jr. said at a news conference. “This administration is committed to recovering taxpayer money lost to health-care fraud.”

Glenn Engelmann, the company’s U.S. general counsel, said AstraZeneca denies the allegations but “takes its obligations very seriously under its agreements with the government. . . . It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines.”

Source: WP

The senate report by the Senate Finance Committee also criticized the FDA, saying that the agency overlooked or overrode safety concerns found by its staff.

“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them,” said U.S. Senator Max Baucus, a Democrat and committee chairman. “Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust.”

GlaxoSmithKline rejected any assertions Saturday that the drug is not safe. ”We disagree with the conclusions in the report,” company spokeswoman Nancy Pekarek told CNN. “The FDA had reviewed the data and concluded that the drug should be on the market.”

Seven clinical trials on the drug prove that it is not linked to heart attacks, Pekarek said. ”None of that data shows a statistically significant correlation between Avandia and myocardial ischemia or myocardial infarction [heart attack],” she said.

Ischemia is a condition in which blood flow and oxygen are blocked from going to certain parts of the body.

The Senate report was developed over the past two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA and several research institutes. Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers.

“GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report says.

As an example, committee investigators say they found that GlaxoSmithKline experts verified an outside study showing the cardiac problem, but the company publicly attacked the findings as incorrect.

• Two FDA safety officials sounded a clear alarm in October 2008 writing, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [rival drug on market].” They concluded and trials comparing the two would be “unethical and exploitive.” Yet, the trial is still under way, the senators say.

The Senate report does not address the issue of whether Avandia should be removed from the market.

The FDA is taking steps to curb use of some long-acting asthma drugs taken by millions, issuing safety restrictions to lower an uncommon but potentially life-threatening risk that asthma could worsen suddenly.

Nor should LABA-containing drugs ever be used without simultaneous use of a different asthma-controlling medication, such as an inhaled corticosteroid — a move that specifically targets two of the drugs, Foradil and Serevent, the FDA said.

These four drugs contain an ingredient that relaxes muscles around stressed airways, called a long-acting beta agonist or LABA. While they’re very helpful at preventing day-to-day symptoms for some patients, the way LABA-containing drugs work also sometimes masks that inflammation is building in the airways. That means patients may not realize a serious asthma attack is brewing until they’re gasping for air.

The FDA cited studies that showed an increased risk of hospitalization and even some deaths, particularly among children. One study found three extra adverse events — mostly hospitalizations — for every thousand patients who took a LABA-containing drug compared to another asthma medication, said FDA’s Dr. Gerald Dal Pan.

FDA’s advice that patients quit the LABA-containing drugs as soon as their asthma is under control and go back to standard medications such as inhaled corticosteroids for day-to-day maintenance.

People with other lung diseases, such as chronic obstructive pulmonary disease or COPD, use the drugs without the asthma risk, and just saying they shouldn’t be used for asthma would have little practical effect, said Dr. John Jenkins, FDA’s director of new drugs. So FDA labeled LABA-containing medications as contraindicated without simultaneous use of a different asthma-controlling medication — a legal term with more enforcement muscle to limit prescription. FDA will monitor that, to see if doctors follow the rules.

Advair and Serevent are marketed by GlaxoSmithKline, Foradil by Novartis AG and Symbicort by AstraZeneca.

It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008.Federal regulators criticized the company, saying it didn’t respond to the complaints quickly enough, wasn’t thorough in how it handled the problem and didn’t inform the Food and Drug Administration quickly.

The recall includes some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin.

The FDA and Johnson & Johnson’s McNeil Consumer Healthcare Products said they did not know the number of bottles recalled. It included caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji.

Consumers should check the full list at http://www.mcneilproductrecall.com/page.jhtml?id=/include/prd_tylenol.inc to identify the recalled batches.

The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it.

The smell is caused by small amounts of a chemical associated with the treatment of wooden pallets, Johnson & Johnson said. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.

The New Brunswick, N.J., company said it is investigating the issue and will stop shipping products with the same materials on wooden pallets. It has asked suppliers to do so as well.

The FDA said McNeil knew of the problem in early 2008 but made only a limited investigation.

“McNeil should have acted faster,” said Deborah Autor, the director of the FDA’s Office of Compliance of the Center for Drug Evaluation and Research. “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.”

The FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way, Autor said.

Johnson & Johnson has 15 days to respond. The FDA says it wants an explanation as to why the problem was not made public sooner.

In November, McNeil recalled some Tylenol Arthritis Caplets due to the smell. Almost three weeks ago, the company expanded its recall to include more batches of Tylenol Arthritis Caplets.

There have been no reports of nausea related to the most recent recall, the company said. McNeil, however, said the expanded recall includes product lots that could be affected by the same problems of nausea.

The company said it is working with the FDA.

Also on Friday, federal prosecutors in Boston said Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug.

The government’s complaint states that J&J gave special rebates to Omnicare Inc., the country’s biggest dispenser of prescription drugs to nursing homes, in return for recommendations from its pharmacists that patients be given Risperdal, in many cases when it was inappropriate.

J&J said in a statement it “will address the government’s lawsuit in court” and believes its rebates were “lawful and appropriate.”

The FTC entered a final consent agreement with Constellation Brands concerning the FTC’s charges that ads for Wide Eye Schnapps caffeinated drinks were deceptive. Wide Eye Schnapps was a product containing 30 percent alcohol by volume.  Ad claims included “Wake Up @WideEye.com,” “I am your wake up call,” and “When you party with the world’s first caffeinated schnapps it’ll seem like the rest of the world is sleepwalking through life.”  According to the FTC, these claims expressly or by implication promised that consumers will remain alert while consuming Wide Eye.  A number of state attorneys general had also called on the FTC to crack down on Wide Eye, arguing that it, like other popular energy drinks, appealed to youth and underage drinkers.  Prior to product launch, Constellation had obtained all required U.S. Alcohol & Tobacco Tax & Trade Bureau (TTB) approvals for Wide Eye and the product’s brand name and tagline were subsequently found to be in accordance with the voluntary DISCUS Code of Responsible Marketing Practices.

The consent agreement, which does not constitute an admission of a violation of law, prohibits Constellation from representing “expressly or by implication, including through the use of a product name or endorsement, that such product…will counteract the effects of alcohol consumption” unless the advertiser has “competent and reliable scientific evidence” supporting that representation.  The FTC order pertains not just to Wide Eye, but also to any other alcohol product containing caffeine, ginseng, taurine, guarana, or any stimulant.  The Order puts any such Constellation products under the FTC’s close eye until the order expires in 2029.

National Alliance to Prevent Underage Drinking letter to FTC
FTC Complaint
FTC Decision and Order

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In the letter, the FDA said that it reviewed two Sotradecol web pages located on the Bioniche Pharma website (www.sotradecolusa.com or “Bioniche web page”) and the AngioDynamics, Inc. website (www.angiodynamics.com/pages/products/Sotradecol.asp or “AngioDynamics web page”) as part of its routine monitoring and surveillance program.  The agency found that these two web pages were misleading because they (1) presented efficacy claims for Sotradecol but failed to communicate any information about the risks associated with the brand, (2) broadened Sotradecol’s approved use, and (3) overstated Sotradecol’s efficacy.

Specifically, the FDA said that the Bioniche and Angiodynamics web pages “entirely omit risk information for Sotradecol.”  The letter also states that these web pages made claims that “entirely avoid mention of the actual indication, which is for the treatment of a very limited subset of varicose veins, and misleadingly suggest that Sotradecol is appropriate for use in all sclerotherapy patients and procedures.  The Contraindications and Precautions sections of the product label lists numerous conditions in which Sotradecol is either inappropriate or should be used with extreme caution, and these two web pages failed to present such material limitations and thus broadened Sotradecol’s FDA-approved indication.  Third, the FDA said that a graphic contained in one of the web pages “overstates the efficacy of Sotradecol” and “fails to provide any information regarding the ranges of the results patients may achieve depending on [several] variables.”

The FDA also expressed concern over Bioniche’s “continued violative promotion of this product,” because this is not the first time the agency sent Bioniche a letter like this.

In an earlier letter dated April 14, 2006, the FDA told Bioniche Pharma to immediately cease the dissemination of violative promotional materials for Sotradecol and to respond to the agency within four days.

In the 2006 letter, the FDA said that it reviewed a product brochure for Sotradecol that was submitted by Bioniche Pharma Group and made available on the product website.  The agency found it to be misleading because it presented numerous claims about how safe and effective Sotradecol, but failed to reveal material facts, minimized the risks associated with Sotradecol treatment, broadened the indication, included unsubstantiated claims, and presented misleading graphics.

If you have been treated with Sotradecol on or before September 14, 2009, you may be entitled to compensation.

This notice applies to all residents of Arkansas, California, Connecticut, Florida, Kansas, Missouri, New Jersey, New Mexico, New York, Ohio, South Carolina, Vermont, Washington, and Wisconsin.  If you live in one of these states, you may be eligible for compensation if you were prescribed and purchased Sotradecol on or before September 14, 2009.

The law firm of Bailey Perrin Bailey is actively reviewing potential Sotradecol cases of deceptive advertising against Bioniche Pharma USA, LLC and Angiodynamics, Inc.  Please click here to contact an attorney.