Avandia risks under the FDA spotlight again

Markus MacGill

pharmaphorum

The US Food and Drug Administration is having a fresh look at the risks of taking diabetes drug Avandia (rosiglitazone). Following reports of heart risks, the drug was taken off the European market last year and the FDA imposed restrictions on its use in the US.

An FDA advisory meeting is now set for June to freshly analyse data from the RECORD study. The review may result in further restrictions, or the drug being taken off the US market – an option that analysts believe is likely, according to Bloomberg.

“We welcome the opportunity to update the US Food and Drug Administration about completion of these post-marketing requirements related to Avandia. GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label”

Mary Anne Rhyne, GlaxoSmithKline spokeswoman.

GlaxoSmithKline has already taken multi-billion dollar charges over Avandia, once a blockbuster drug for the UK company.

The FDA says its June 5 and 6 meeting has been scheduled because of its concerns about the original design and conduct of the RECORD study.

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Related news:

Glaxo’s Avandia Gets Second Look at Heart Risk by US (Bloomberg)

FDA taking new look at Avandia risks (FiercePharma)

Reference links:

US Food and Drug Administration Avandia information

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