Washington, DCSaudi Arabia has suspended Avandia for six months, saying the risks of the drugs outweigh the benefits. The type 2 diabetes medication has been shown to increase the risk of cardiovascular events, including congestive heart failure.
The Saudi Food and Drug Authority announced that the risk of using Avandia "outweighs its benefits, especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures." The Authority added that there are safer alternatives to Avandia (known generically as rosiglitazone).
Manufacturer GlaxoSmithKline countered that the regulatory authority's action was based on data that did not include "the most recent scientific data on Avandia." The company also said that Avandia is safe and effective when used as directed.
However, the Saudi Food and Drug Authority based its decision on growing evidence from clinical trials, meta-analyses and observational studies that indicated "serious cardiovascular adverse events associated with the use of rosiglitazone." Doctors are advised not to begin new patients on rosiglitazone and to discuss with patients other alternatives for treating type 2 diabetes mellitus.
Researchers concluded that "there is no evidence that rosiglitazone offers any unique health benefit while there is strong evidence that rosiglitazone results in an increased risk of acute myocardial infarction and heart failure compared to pioglitazone" [Actos, a different drug used to treat type 2 diabetes].
The company has six months to provide the regulatory authority with evidence indicating that rosiglitazone and products containing rosiglitazone—including Avandamet and Avandaryl—should not be taken off the market.
GlaxoSmithKline says it will provide the regulatory authority with data from six trials that the company believes prove Avandia is safe.
According to a 3/22/09 report in the Wall Street Journal, Avandia had global sales of $1.2 billion in 2009.
Avandia is still available for use in the United States. In February 2010 the US Senate released a report indicating that GlaxoSmithKline failed to warn patients about the risk of liver failure and heart attacks linked to Avandia. The report also states that if every diabetic person were given Actos rather than Avandia, it would prevent approximately 500 heart attacks monthly.
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