FDA to Require Black Box Warning on Avandia, Actos
The U.S. Food and Drug Administration (FDA) recently announced in congressional testimony that it intends to compel manufacturers of Avandia and Actos, similarly-acting anti-diabetes drugs, to place black box consumer warnings on those drugs, because of their tendency to worsen heart failure in patients whose hearts are compromised.
It is something of a confusing move for consumers, coming as Avandia’s manufacturer, GlaxoSmithKline, is investigated concerning allegations that silenced dissenting researchers during a period of drug testing. Though the new black box warning will address the drug’s potential to worsen heart failure, it does not address current concerns before Congress and the FDA that the drug may also cause heart attacks and increase rates of cardiac death in patients – concerns which officials say have yet to be settled scientifically.
According to 21 C.F.R. § 201.80 (2007), the FDA can compel a manufacturer to label drugs with a black box warning in cases where their use may result in serious risks or hazards (such as death or serious injury). These warnings are generally based on clinical data or, alternatively, on demonstrated animal toxicity.
If you are taking Avandia or Actos, consult your physician about whether these recent cardiac concerns affect your suitability for treatment with these drugs.