FDA in Saudi Arabia suspends diabetes drug Avandia
Distribution of Avandia has been suspended for six months by the Saudi Food and Drug Authority (SFDA), linking use of the diabetes drug to adverse cardiovascular effects. A decision has not been made whether a permanent Avandia recall will follow.
“The S FDA Committee for Medicinal Products Registration has given the company six months to provide evidence as to why the drug should not be permanently removed from the Saudi market,” said Abdullah Al-Humaidan, director of S FDA’s national drug and poison center. He is concerned about the safety of Avandia (generic name “rosiglitazone”) based on growing evidence from clinical studies that Avandia use increases the risk of heart attack and congestive heart failure.
The S FDA stated that the Avandia heart attack risk outweighs its benefit.
Excerpt from the Saudi FDA press release:
Saudi Food and Drug Authority Suspends The Authorisation of Rosiglitazone
01 Rabe’a Al-Thani 1431 (H) Equal 17 March 2010 (G)
The Saudi food and Drug Authority has reviewed the safety of Rosiglitazone (Avandia®) which used in treatment of type 2 diabetes mellitus and marketed in Saudi Arabia as Avandia®. Based on growing evidence from clinical trials meta-analyses and observational studies indicating serious cardiovascular adverse events associated with the use of rosiglitazone as, the Advisory Committee for Pharmacovigilance in Saudi Arabia has concluded the followings:
1. The risk of using rosiglitazone outweighs its benefit especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures.
2. Safer alternatives could be used for treatment of diabetes mellitus are available in Saudi Arabia.
Based on the review it was recommended to suspended rosiglitazone containing product.
Concerns over heart attack risk and other Avandia side effects have lead researchers to call for an Avandia recall in the United States. The U.S. FDA is considering safety issues raised about the diabetes drug and is expected to announce its conclusions at an FDA drug safety meeting in July.