FDA Panel to Consider the Future of Avandia, other Diabetes Treatments

Avandia lawyers at Pintas & Mullins Law Firm affirm that June 7, 2013 marked the start of an FDA advisory committee meeting to reconsider the safety and use of Avandia. Three years ago the agency voted to sharply curtail the diabetes drugs’ use.

A former blockbuster, Avandia was once the top-selling diabetes pill in the world. Now, after reports of its potential cardiac side effects, it is prescribed to only a few thousand Americans, and has been completely pulled from markets in Europe along with several other regions.

As a direct result of the increased risk of heart attack, the FDA substantially overhauled the way it regulates diabetes medications in general, including the exceedingly popular Janumet, Januvia, Byetta, and Victoza. This is due, in no small part, to the overwhelming abundance of diabetes in the United States: nearly 26 million Americans have diabetes in the U.S., which is more than 8% of the population. That number, as troubling as it is, could triple by 2050.

Diabetes is now a leading cause of death in the U.S., accounting for about $170 billion in health care costs. Needless to say, diabetes drug development is a hot market, one every major drug manufacturer wants to be a part of.

GlaxoSmithKline, Johnson & Johnson, and Merck, among several others, all have their hands in the diabetes game, however, many of the drugs are proving to be less than stellar, with such complications as bladder cancer (Actos), thyroid cancer (Victoza), and pancreatitis (Janument, Januvia, Byetta). Other diabetes-focused manufacturers, such as Sanofi, Eli Lilly, and Novo Norkisk, will undoubtedly be eagerly awaiting the FDA’s most recent decision on Avandia, as it could have far-reaching implications for the future of their most profitable drugs.

A major question is why the FDA chose to re-evaluate Avandia in the first place – the issue seemed pretty cut and dry: Avandia caused heart attacks in a demographic already predisposed to cardiac events, so it was restricted and pulled from many markets. The agency did commit, however, to evaluating Avandia whenever new documents and data became available. So now, it is.

At the first FDA meeting regarding Avandia, a specific study conducted by GlaxoSmithKline, called RECORD, was referenced several times. The study was initially submitted to prove the safety and efficacy of Avandia to the FDA, however, it turned out to be significantly flawed and biased, leading the agency to almost completely disregard the trial. The FDA advisory panel is comprised of 27 members, 14 of whom were members of the panel three years ago during the first Avandia evaluation.

Meanwhile, a study recently concluded that the risk for acute pancreatitis doubled in patients prescribed to Januvia. The leader of the study, Dr. Peter C. Butler of the University of California, was invited by the manufacturer of Januvia, Merck, to test the drug on diabetic lab rats.

Dr. Butler found worrisome changes in the rats, particularly in their pancreases. The changes suggested the presence and future development of pancreatic cancer – a major side effect already suspected by regulatory and patient advocate agencies. Both the FDA and the European Medicines Agency took notice of Butler’s study, and are now conducting their own investigation into the drug.

Patients taking Januvia are encouraged to keep note of information and data on the drug, which are expected to be released in the summer of 2013. The National Institutes of Health will also be meeting in July 2013 to study the association between diabetes, diabetic drugs, and pancreatic cancers.

Diabetes drug lawyers at Pintas & Mullins Law Firm will continue to report on any relevant developments concerning these drugs and their side effects. If you or a loved one became seriously ill from use of a diabetic drug, you have important legal rights, and may be entitled to significant compensation for any medical bills, lost wages, and pain and suffering.


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