The Vote Is In: FDA Panel Says Modify the Avandia Restrictions

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After two attempted votes followed by computer glitches and giggles, the FDA panel to assess restrictions on the diabetes drug Avandia narrowly voted Thursday to modify the restrictions.

Avandia, a former “blockbuster” diabetes drug made by GlaxoSmithKline, was put under major safety restrictions in 2010 when studies linked it to heart attack risks. The drug, also known as rosiglitazone, used to be one of the top-selling diabetes drugs on the market. But its $3.2 billion annual sales have since plummeted; only 3,000 people now take the drug.

This week, the FDA panel met to review new information on a clinical trial that showed Avandia is just as safe as other diabetes drugs. The panel of experts discussed the available information and was asked to vote on lifting the restrictions on the drug, withdrawing the drug or leaving it on the market as is.

Among the 26 panel members, 13 voted to modify the restrictions on Avandia, seven voted to remove them, and five opted to leave the restrictions as is. One person supported withdrawing the drug from the market.

(MORE: What the FDA’s Restriction of Avandia Means for Diabetes Patients)

Regardless of the decision, it might be too late for Avandia to recover. As Reuters reported, Glaxo has said it has no plans to promote the use of Avandia again, even if the restrictions are lifted. The company has settled thousands of lawsuits from former Avandia patients who say they were not made aware of the risks. In July, the company agreed to pay a $3 billion settlement for not providing the FDA with safety data and improperly marketed the drug.

The panel members who voted for modifications were asked for suggestions on how best to implement them. Not all the panel members voiced opinions, but committee member Marjorie Shaw Phillips, a pharmacy coordinator at Georgia Health Sciences Medical Center and adjunct assistant professor at Georgia Health Sciences University’s Medical College of Georgia, noted that increased availability of the drug makes it worthwhile to track patient understanding of the risks and benefits and make sure there is a patient education plan in place.

The panel’s vote, which is not binding, is a recommendation to the FDA.

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