CardioExchange Archive

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of the journal, Fiona Godlee, to say that she believes rosiglitazone “should not have been licensed and should now be withdrawn.”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 […]

---