-
A House Divided: No Clear Answers on Rosiglitazone Safety or Political Backstory
New black-box warnings about CHF risk are in the works for the glitazone drugs, but whether rosiglitazone increases MI and CV death rates, debated during Wednesday's oversight committee hearing, remains unresolved. Participants also quibbled over the FDA's handling of drug data and the role of partisan politics in medical matters.
News, June 2007
-
RECORD Interim Analysis of Rosiglitazone Safety: No Clear-Cut Answers
One RECORD investigator calls interim findings from RECORD "moderately reassuring": at 3.75 years there are no differences in risk of hospitalizations or death from cardiovascular causes. While MI trends higher, deaths trend lower in the results so far. Three accompanying editorials take a considerably dimmer view.
News, June 2007
-
Rosiglitazone Tied to Reduced Bone Mineral Density in Men
Treatment with rosiglitazone (Avandia) reduces bone mineral density (BMD) in men with type 2 diabetes, according to a report in the June issue of Diabetes Care.
News, June 2007
-
Rosiglitazone Meta-Analysis Continues to Drive Controversy in Second Week
The rosiglitazone story rumbles on this week, with some observers claiming that the meta-analysis was timed to get data into the public arena without the FDA’s knowledge, thereby bringing the subject of drug safety to the fore once more. In the meantime, the one ongoing trial that everyone agrees will give definitive information on cardiovascular outcomes with rosiglitazone could be in jeopardy, as some participants desert the study due to safety concerns.
News, May 2007
-
Glaxo's Avandia Study in Jeopardy: Official
Drug maker GlaxoSmithKline's medical director said the company's study of the heart risk associated with its Avandia diabetes treatment may be in jeopardy because patients have dropped out following reports of the drug's risks, The New York Times reported on Saturday.
News, May 2007
-
The Rosiglitazone Aftermath: Legitimate Concerns or Hype?
Experts give heartwire their take on the furor that has resulted from the meta-analysis published earlier this week. The prevailing view appears to be that there is no need for panic and that while the analysis does suggest a safety signal, it does not justify removing the drug from the market at this time or the general chaos that has occurred.
News, May 2007
-
Lawyers Forecast Flood of Avandia Litigation
GlaxoSmithKline Plc is expected to be hit with a wave of lawsuits from users of the diabetes drug Avandia, plaintiff's lawyers said on Wednesday.
News, May 2007
-
Recalls & Warnings Rosiglitazone Increases MI and CV Death in Meta-Analysis
Lead author Dr. Steve Nissen says the findings need confirmation but could have a substantial public-health impact. In an accompanying editorial, Drs. Bruce Psaty and Curt Furberg say the rationale for prescribing rosiglitazone at this time is unclear and that unless new data provide a different picture of the risk/benefit profile, regulatory action by the FDA is now warranted.
May 2007
-
Recalls & Warnings Pioglitazone Linked to Fracture Risk in Women
A database study conducted by the drug's maker shows an increased risk for upper/lower distal fracture vs a comparator drug or placebo.
March 2007
-
Recalls & Warnings Rosiglitazone Linked to Fracture Risk in Women
Results from ADOPT show increased upper arm, hand, and foot fractures with rosiglitazone vs metformin or glyburide monotherapy.
February 2007
-
Recalls & Warnings Rosiglitazone Linked to New/Worsening Macular Edema
The condition has improved or resolved in some patients after discontinuation of therapy.
January 2006
-
Glitazone Use May Be Associated With Macular Edema in Diabetics
Investigators suspect a link between fluid retention associated with glitazone use in diabetics and the eye disease.
News, November 2003
