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FDA Dysfunction Leaves Avandia-Taking Patients to Watch Out for Their Own Safety

By July 21, 2010July 17th, 2019Dangerous Drugs

Doctors and patients are worried about whether the diabetes drug Avandia (rosiglitazone) is safe, as I’ve discussed on several occasions this year from my perspective as a dangerous prescription medication lawyer. Avandia has been associated in several studies with a marked increase in heart problems, including life-threatening heart failure. But a recent report from MedPage Today suggests that FDA seems determined not to take this drug off the market, despite those studies. An FDA advisory committee voted 20-12 in favor of keeping Avandia on the market, but 17 of the supporters wanted the drug to carry tougher warning labels. Avandia already has a black box warning, the FDA’s strongest warning of a drug’s risks, advising patients that it increases the risk of heart failure. So it’s not clear how much good another warning label about risks of heart problems would do to prevent patients from being harmed by Avandia. As Joel Zonszein, MD, of Albert Einstein College of Medicine said, “The physician is left in limbo” by this decision.
Speaking as a href=””>pharmaceutical liability attorney, I believe it’s good that FDA staff members and advisors are debating Avandia’s risks, because that makes it more likely that they’ll consider all relevant viewpoints. However, Thomas Marciniak, MD, an FDA staff reviewer, said that the debate over Avandia has turned into a turf battle between the drug’s supporters and detractors, with some newcomers to the agency in the middle. Marciniak said higher-ups at the FDA reward positive assessments of drugs, while negative assessments lead to “endless meetings.” Another FDA staff reviewer, David Graham, MD, pointed out that the members of the FDA advisory panel voting on Avandia’s fate seemed to have been chosen to ensure a favorable outcome for Avandia. In addition, Graham alleged that higher-ups at the FDA leaked information to a popular medical blog about an Avandia study he had conducted in order to delay or prevent the study’s publication.
It’s unclear why the FDA wants to keep Avandia on the market, but it’s clear why GlaxoSmithKline, Avandia’s maker, might be interested in doing so. We’ve already seen that the company is deeply invested in protecting Avandia. It’s a profitable drug, and type 2 diabetes rates have been drastically increasing along with obesity rates. Obesity is considered a leading cause of type 2 diabetes. This means that GlaxoSmithKline stands to rake in increasing profits from Avandia as an increasing number of people need treatment for type 2 diabetes. From my perspective as a defective drug lawyer, this only adds to the questions about why the FDA seems to be protecting Avandia’s place on the market.

Despite the FDA’s slowness and drugmakers’ denials that any problems exist, patients who are harmed by Avandia or similar drugs, have rights. That includes the right to sue the manufacturers of the drugs that harmed them for compensation for medical costs, lost past and future wages, lost quality of life, and pain and suffering. The law recognizes that patients should not have to bear all the consequences alone if they find out that the medications that they had trusted to help them actually made them sicker. At Carey, Danis & Lowe, we specialize in helping families facing this kind of harm from defective medications. Our years of experience in this field have taught us what to expect in dangerous drug cases and how to obtain the best outcomes for our clients. If you have been hurt by a defective medication, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.