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Saudi Government Bans Avandia (Georgia/Florida)

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.

The Saudi Food and Drug Authority said on its website that the risk of using Avandia, also known as rosiglitazone, "outweighs its benefit, especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures."

It said safer alternatives could be used there instead.

Glaxo responded by saying "the Saudi regulatory authority action is based on a review that did not include the most recent scientific data on Avandia."

"GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label and maintains that this is an important medicine for the treatment of type 2 diabetes."

Glaxo now has six months to provide the Saudi drug regulator with evidence of why rosiglitazone and combination products containing it should not be taken off the Saudi market permanently. Rosiglitazone containing products marketed in Saudi Arabia are Avandia , Avandamet and Avandaryl.

http://online.wsj.com/article/BT-CO-20100322-710067.html?mod=WSJ_latestheadlines

Full post as published by A Georgia Lawyer on March 30, 2010 (boomark / email).