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FDA To Reassess Safety Risks Of Diabetes Drug Avandia

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

A federal health advisory will take another look at the diabetes drug Avandia this June.

According to Mary Anne Rhyne, spokeswoman for Avandia drugmaker GlaxoSmithKline, the U.S. Food and Drug Administration advisory panel will meet on June 5-6 to discuss the drug. Rhyne speculated that the panel will ask for an update on safety information it sought from the drugmaker in 2010, when the FDA placed severe restrictions on the pill, due to heart attacks and deaths linked to the product.

"We haven't asked for any changes in the drug label or in distribution for Avandia," Rhyne said, adding that GlaxoSmithKline had not requested the planned June meeting of the FDA's Endocrinologic and Metabolic advisory panel, which will be held jointly with the FDA's Drug Safety and Risk Management Advisory committee.

Glaxo estimates that only about 3,300 people in the U.S. still take the former blockbuster product.

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