Saudi Arabia Suspends Avandia Diabetes Pill

In response to the controversy renewed by a recent US Senate Finance Committee report, Saudi Arabia's Food and Drug Authority has suspended use of GlaxoSmithKline's Avandia for six months while a review is under way. "We reviewed the leaflets and the reports, and these opened our eyes toward this medication," says Abdullah al-Humaidan, director of the SFDA's national drug and poison center. "Safety is a big issue." The move means that Avandia can still be prescribed, but supplies are halted.

A statement on the SFDA site says: "Based on growing evidence from clinical trials meta-analyses and observational studies indicating serious cardiovascular adverse events associated with the use of rosiglitazone (Avandia), the Advisory Committee for Pharmacovigilance in Saudi Arabia has concluded...the risk of using (Avandia) outweighs its benefit especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures, and safer alternatives could be used." And here is the SFDA report, which was issued last month.

The SFDA met with Glaxo officials to inform of their decision and another meeting is planned for March 27, according to al-Humaidan. "While the US FDA is still debating, we need to give the company a chance to provide us with any kind of recommendation to change our position," he says. "But after six months, they haven't done so, I believe we will just pull it from the market."

Avandia currently holds about 25 percent of the Saudi market for diabetes drugs, according to Larry Sasich, a consultant to the Saudi FDA and a former research analyst at Public Citizen, the consumer advocacy group.

The Senate Finance Committee report, you may recall, contained info about an internal US FDA debate over Avandia, and charged Glaxo with attempting to minimize and downplay findings about cardiovascular risk. Two agency reviewers, David Graham and Kate Gelperin, concluded the pill should be yanked in the US, although their reports were never released publicly. Glaxo has vigorously defended its drug and its conduct. The US FDA, meanwhile, plans to hold an advisory committee meeting this summer to review the evidence.

UPDATE: Glaxo send this response: "The Saudi regulatory authority action is based on a review that did not include the most recent scientific data on Avandia. The agency did not consider, for example, the final results of RECORD which demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas. "Glaxo will present information in writing and in person to the SFDA from the six large, prospective, randomized, clinical trials with information on the cardiovascular safety of Avandia that have reported results (i.e., RECORD, VADT, ACCORD, BARI-2D, APPROACH, and VICTORY) since 2007. None of these randomized clinical trials, which remain the gold standard for evaluating scientific and medical questions, shows a statistically significant association between Avandia and myocardial infarction (MI) or other ischemic cardiovascular events. "In the US. the FDA has reinforced with a public health posting on February 22, 2010, that there are 'no new FDA conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes.' The FDA is now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies and will bring its review to an advisory committee meeting this summer."