Sunday, 29 July 2007

Double the heart risk for Avandia and Actos

Filed under: , , , , ,

More negative news on Avandia, and this time Actos is implicated, too. Avandia and Actos are thiazolinediones, oral meds used to treat people with type 2 diabetes. A new study by US and UK researchers examining research and case reports on over 78,000 takers of thiazolinediones reveals double the risk of heart failure.

Here is the statistic that struck me, especially when you consider the millions of people taking these drugs. Study authors stated there is one extra heart failure for every 50 type 2s taking thiazolinediones over a 26-month period. Chilling. Lead author, Dr. Sonal Singh, stated more than 3 million take these drugs in the US, which equates to several thousand potentially harmed. More fire for the growing pool of litigation.

Interestingly, the amount of the drug does not seem to play a role -- the study found risk occurred equally at low or high doses, with an average of 24 weeks from starting a prescription to heart failure. Men and women are at equal risk, and 25 percent of cases affected people under the age of 60. The study points toward fluid retention as the possible cause of heart failure in Avandia or Actos-takers, as both cause retention of fluid. Co-researcher, Dr. Curt Furburg, stated the findings support a black box warning on both Avandia and Actos. Read more on this research in Medical News Today. The study will appear in the August print issue of Diabetes Care.

An outside advisory panel to the Food and Drug Administration is meeting Monday, July 30 to address GlaxoSmithKline's Avandia mess. Perhaps a similar panel will be meeting in the future to discuss Takeda's Actos, too. Check out the FDA's briefing document for Monday's meeting. Keep in mind, it is 436 pages. See page two -- I wonder what the panel's answer will be to Draft Question #4?

No comments: