May 18th, 2011
FDA Announces Details of Severe New Restrictions on Rosiglitazone
Larry Husten, PHD
The FDA has announced the details of the updated REMS (risk evaluation and mitigation strategy) for rosiglitazone, the embattled and highly controversial diabetes drug. The new REMS will sharply restrict access to and distribution of drugs containing rosiglitazone (Avandia, Avandamet, Avandaryl). In order for physicians to prescribe and for patients to receive rosiglitazone, they will need […]
March 17th, 2011
Meta-Analysis Suggests Worse Outcomes For Rosiglitazone Compared To Pioglitazone
Larry Husten, PHD
There are no long-term trials directly comparing rosiglitazone and pioglitazone. In an article published in BMJ, Yoon Kong Loke and colleagues performed a systematic review and meta-analysis of 16 observational studies with more than 800,000 thiazolidinedione users in an attempt to assess the relative cardiovascular effects of the two drugs. When compared with pioglitazone, rosiglitazone was […]
September 26th, 2010
Avandia: Lessons Learned and Unanswered Questions
Harlan M. Krumholz, MD, SM
The following is republished from Pharmalot, a widely read site that provides commentary on the pharmaceutical industry and related litigation. What should we make of the decisions on Avandia yesterday? There remains some controversy about the risk, but the concerns were sufficient, given the therapeutic alternatives, to bring about action. The Europeans decided to suspend sales […]
September 23rd, 2010
FDA and EMA Split on Fate of Avandia
Larry Husten, PHD
The FDA and the European Medicines Agency announced separate and divergent decisions on the fate of rosiglitazone (Avandia) today. On the one hand, the FDA announced that it would allow rosiglitazone to remain on the market, though only with severe restrictions on its use. Additionally, the FDA said it would require the drug’s manufacturer “to convene […]
September 7th, 2010
BMJ Papers Increase Pressure on Avandia
Larry Husten, PHD
A trio of papers in BMJ are turning up the heat on rosiglitazone (Avandia), prompting the editor-in-chief of the journal, Fiona Godlee, to say that she believes rosiglitazone “should not have been licensed and should now be withdrawn.” The detailed investigative report by BMJ features editor Deborah Cohen reviews the long and troubled history of rosiglitazone, with […]
July 26th, 2010
Questions for Sanjay Kaul about TIDE and Avandia
Sanjay Kaul, MD and Harlan M. Krumholz, MD, SM
CardioExchange’s editor-in-chief Harlan Krumholz discussed the TIDE trial on email with Sanjay Kaul, who was a member of the FDA’s advisory panel last week on Avandia. Here is a lightly edited version of their exchange. Krumholz: What is your response to the FDA announcement that it has placed TIDE on a “partial clinical hold”? Do you […]
July 22nd, 2010
Lessons Learned from 2 Avandia Panels
Larry Husten, PHD
In a perspective published online in the New England Journal of Medicine, Clifford Rosen, who was the chair of the 2007 FDA Advisory Panel that allowed rosiglitazone (Avandia) to remain on the market and also a member of the panel that met last week, writes about “lessons learned” from the extraordinary series of events involving […]
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