CardioExchange Archive

November 25th, 2013

FDA Removes Restrictions on Avandia

Larry Husten, PHD

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said its […]

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June 7th, 2013

FDA Advisory Panel Backs Looser Restrictions on Avandia

Larry Husten, PHD

After two days of deliberation an FDA advisory panel has recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline [GSK]) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. […]

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June 4th, 2013

With One Big Exception FDA Reviewers Back More Benign View of Avandia Trial

Larry Husten, PHD

The FDA has released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by […]

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May 29th, 2013

Report on the RECORD Trial Released

Larry Husten, PHD

An independent re-adjudication of the RECORD trial has confirmed the trial’s original finding that rosiglitazone does not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary 2-day FDA advisory committee meeting next week on […]

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May 24th, 2013

Spinning RECORD: Battle Over Rosiglitazone Heats up Two Weeks Before Crucial FDA Meeting

Larry Husten, PHD

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline [GSK]). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at […]

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April 13th, 2013

FDA Schedules Another 2-Day Avandia Advisory Panel

Larry Husten, PHD

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on April 15, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  “discuss the results […]

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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 […]

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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 […]

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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 […]

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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 […]

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