New FDA Report Renews Safety Concerns with Avandia
New FDA Report Renews Safety Concerns with Avandia
UPDATE: September 23, 2010: The Food and Drug Administration announced that Avandia will be permitted to remain on the market, but under extremely restricted circumstances. See the Press Release Timeline for more details.
UPDATE: July 21, 2010: This afternoon, the 33-member FDA advisory committee cast votes to decide whether or not to withdraw Avandia from the market. Twelve committee members voted to withdraw the drug; another ten voted to allow continued sale of the drug on the condition that sale was restricted and the label revised; and the remaining seven committee members voted to update the drug's label with new warnings. The committee also voted on whether or not to continue the controversial TIDE trial. Nineteen members voted to continue the trial, and eleven voted to end it. The FDA will make its final decision at a later date.
The diabetes drug Avandia (rosiglitazone) has been under scrutiny for several years. In 2007, an advisory committee concluded that while Avandia does increase the risk of heart attacks and strokes, the benefits outweighed the dangers. The committee’s decision was based on the 2007 RECORD trial, which investigated the relationship between rosiglitazone and cardiac events.
In the years since, GSK has presented the trial as evidence of their drug’s safety. Some detractors argued that the study was incomplete or biased, and today, the FDA appears to agree.
FDA reviewer Dr. Thomas Marciniak's report, which can be found on the FDA website, includes excerpts from the RECORD trial that discuss the risks of rosiglitazone and, in Marciniak’s opinion, the researchers' attempts to downplay this information. GlaxoSmithKline’s interpretations of the study results were so skewed, Marciniak writes, that they “suggest serious flaws with trial conduct.”
At the 70th Annual Scientific Sessions of the American Diabetes Association last month, Dr. Richard G. Bach presented a GSK-sponsored post-trial analysis that indicates “no link between diabetes drug rosiglitazone and increased rate of heart attack.” But that same day, the Journal of the American Medical Association (JAMA) announced publication of its own Avandia analysis, authored by an FDA reviewer, which also linked the drug to an increased risk of heart attack, stroke, and death when compared to another drug in the TZD class, Actos.
So what, then, is the truth? And what comes next? Next week, another FDA panel of experts will convene for a two-day meeting to discuss the findings and the possibility of adding additional labeling to Avandia or withdrawing the product from the market. On July 12, the Senate Finance Committee sent a letter to the FDA regarding Avandia's safety and GlaxoSmithKline's responsibilities. You can read the letter here. You can also read all the related press releases in the Press Release Timeline at the bottom of this page. dLife will have updates as they become available.
And remember: do not discontinue any diabetes drug without first talking to your doctor. If you are on Avandia and have concerns, contact your healthcare provider.
Press Release Timeline:
September 23, 2010 FDA Significantly Restricts Access to the Diabetes Drug Avandia - FDA Significantly Restricts Access to the Diabetes Drug Avandia
September 23, 2010 GSK Regulatory Update On Avandia Following EMA and FDA Reviews - GlaxoSmithKline responds to the FDA's statement
July 20, 2010 GlaxoSmithKline Responds to FDA Advisory Panel Votes on TIDE Trial - GlaxoSmithKline Statement in Response to FDA Announcement on TIDE Trial
July 14, 2010 FDA Advisory Panel Votes
July 13, 2010 GlaxoSmithKline Responds to Senate Committee Findings - GlaxoSmithKline (GSK) Responds to Senate Finance Committee Letter of 12 July to FDA
July 13, 2010 Senate Finance Committee Releases Findings - Baucus, Grassley Find Company Failed to Promptly Alert FDA About Drug Risks
July 12, 2010 Johns Hopkins University Faculty Respond to Controversy - Hopkins Faculty Lead Development of Report to FDA on Ethical, Scientific Issues Related to 'Post-Market' Clinical Trials
July 9, 2010 GlaxoSmithKline Responds - Data Support Avandia (Rosiglitazone Maleate) Cardiovascular Safety Profile
June 28, 2010 Reported at the 70th Annual Scientific Sessions of the ADA - Type 2 Diabetes Medication Rosiglitazone Associated with Increased Cardiovascular Risks and Death
June 28, 2010 Reported at the 70th Annual Scientific Sessions of the ADA - Study Finds No Link Between Diabetes Drug Rosiglitazone and Increased Rate of Heart Attack
1 - Marciniak, Thomas. 2010. Cardiovascular Events in the RECORD Trial. FDA.gov.
2 - Juurlink, David N. 2010. Rosiglitazone and the Case for Safety Over Certainty. JAMA 2010;304(4).
3 - Graham, David J. et al. 2010. Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated with Rosiglitazone or Pioglitazone.JAMA 2010; 304(4).
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