Avandia Health Alert: FDA Severely Limits Availability of Diabetes Drug

Avandia has been in the news a lot lately, for all the wrong reasons. The drug, once widely prescribe for type 2 (adult-onset) diabetes, most recently made headlines as federal regulators in the United States cracked down to severely limit its availability (European regulators, meanwhile, suspended its sales outright).

In the U.S. the drug, known generically as rosiglitazone, will be available only if patients and their doctors report that every other diabetes drug has been tried and has failed. Patients also must be alerted to the drug’s very serious cardiovascular side effects—including risk of heart attack and stroke. Patients currently on Avandia are being allowed to continue taking the drug.

Avandia Linked to Heart Attack, Stroke, Cardiovascular Disease

Avandia quickly became a blockbuster drug after its introduction in the U.S. in 1999. Eight years later, a landmark analysis indicated the drug was linked to a substantially higher risk of heart attack or cardiovascular-related death than other similar drugs.

U.S. regulators first issued a safety alert about the drug in May 2007, warning that patients with existing heart disease or at high risk of heart attack should consult with their doctors to reconsider use of the drug. Later that year, the Food and Drug Administration ordered “black box warnings” for the drug’s labeling, alerting prescribers to possible heart-related dangers. At the time, GlaxoSmithKline continued to assert that Avandia was safe and effective, arguing that other studies showed no increased risk of harm.

Despite the plummet in sales after the 2007 controversy, Avandia has remained widely promoted by GlaxoSmithKline. Sales of the drug last year totaled more than $1 billion. Multiple studies since then have linked Avandia to a higher risk of stroke, heart attack, congestive heart failure or cardiovascular-related death.

Studies of Avandia by Manufacturer Prove Controversial

In 2008, despite objections of consumer advocates and others who cited the drug’s serious cardiovascular dangers, the FDA ordered GlaxoSmithKline to conduct a clinical trial, called TIDE, to further assess Avandia’s safety in comparison with other drugs including Actos (pioglitazone), a related medicine whose risk has been found in some studies to be lower.

In September 2010, the FDA ordered that the trial be stopped. The agency also ordered the manufacturer to conduct an independent analysis of another controversial trial it sponsored, called RECORD, that an FDA expert found riddled with errors and prone to bias. The agency noted that it might take additional actions after the new analysis is completed.

In a press release describing the new restrictions, GlaxoSmithKline stated that it “continues to believe that Avandia is an important treatment for patients with type 2 diabetes.”