Saudi Food and Drug Authority Suspends The Authorisation of Rosiglitazone (Avandia®)

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.

For further information, please visit:
http://www.sfda.gov.sa

Avandia in the News:

  • (Reuters) - Saudi Arabia has suspended GlaxoSmithKline's (GSK.L) diabetes drug Avandia for six months, arguing that potential heart risks outweigh its benefits. Read more...
  • (Dow Jones) Saudi Arabia has suspended GlaxoSmithKline PLC's (GSK) diabetes drug Avandia for six months, saying the product's heart risks outweigh its benefits, but the U.K.-based drug maker said its stands by the controversial drug. Read more...

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