March 22, 2010
Saudi Arabia suspends Glaxo diabetes drug Avandia
By Ben Hirschler
* Saudi move first of its kind, after controversy over drug
* Six-month suspension gives Glaxo chance to put its case
LONDON, March 22 (Reuters) - Saudi Arabia has suspended GlaxoSmithKline's (GSK.L) diabetes drug Avandia for six months, arguing that potential heart risks outweigh its benefits.
The Saudi Food and Drug Authority (SFDA) was the first healthcare regulator to take such action. Its decision means detailing and advertising of Avandia is banned and patients on Avandia will be referred to their doctor for consultation. The SFDA said on its website it was concerned about the safety of Avandia, or rosiglitazone, based on growing evidence from clinical studies indicating serious cardiovascular risks. (link.reuters.com/zab74j)
The six-month suspension will give Glaxo "the opportunity to provide the SFDA with evidence as to why rosiglitazone and combination products containing rosiglitazone should not be permanently removed from the Saudi Arabian market," it said.
The Saudi move follows a highly critical report on the drug from U.S. Senators last month, which suggested Glaxo knew of possible heart attack risks associated with Avandia years before the issue became public. [ID:nN20149014].
Glaxo has denied the Senators' allegations.
A spokeswoman said on Monday the company would provide the SFDA with data from six clinical trials demonstrating the cardiovascular safety of Avandia. "We stand behind the safety and efficacy of Avandia when it is used appropriately." (Reporting by Ben Hirschler; Editing by Dan Lalor)
Julie Steenhuysen, Chicago, Reuters
Vera Hassner Sharav, AHRP