Roughly a month after the release of a U.S. Senate Finance Committee report that accuses GSK of hiding unflattering data on Avandia, Saudi Arabia's Food and Drug Authority has announced it has suspended use of the Type 2 diabetes drug for six months, citing evidence from a meta-analyses and observational studies linking the drug's use to cardiovascular adverse events.
The Committee for Medicinal Products Registration gave GSK six months "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." Products containing rosiglitazone that are marketed in that country include Avandia, Avandamet and Avandaryl, according to a statement issued by the SFDA. "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, as quoted by Pharmalot. "Safety is a big issue." The move means that Avandia can still be prescribed, but supplies are halted.
According to the SFDA, the Saudi Arabian Advisory Committee for Pharmacovigilance has concluded that the risk of using rosiglitazone outweighs its benefits and that there are safer alternatives to treat diabetes mellitus. Saudi doctors have been advised not to start new patients on the drug and should discuss safer alternatives for those already using the drug to treat Type 2 diabetes.
The SFDA has met with GSK officials and another meeting is planned for March 27, Pharmalot notes. "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."
The safety of Avandia has been up for debate for a few years now, ever since Cleveland Clinical cardiologist Steve Nissen released details from his meta-analysis of trial data. That study suggested that the drug increased the risk of heart attack. The FDA has issued warnings and sales have dropped, though an advisory committee recommended--and agency decided--to keep the drug on the market.
- see the SFDA's announcement
- check out Pharmalot's coverage