Double whammy for GlaxoSmithKline, as European regulator suspends Avandia and US FDA further restricts use of the diabetes drug

GlaxoSmithKline (LSE: GSK) suffered a double dose of bad news yesterday, when the European Medicines Agency (EMEA) decided to withdraw the marketing approval of UK pharmaceutical giant’s diabetes drug Avandia (rosiglitazone) on the grounds of much-publicized cardiac risks. Also, the US Food and Drug Administration issued a statement saying it would “significantly restrict” the use of Avandia to those diabetics who cannot control their condition with alternative medicines, so stopping short of a total ban.

A US Food and Drug Administration advisory panel recently voted to keep Avandia on the market, with added warnings (TPL July 15) and GSK has consistently maintained that the drug, which has seen its sales tumble over the years since the cardiac risk was first signalled in 2007, if used as indicated. However, it has now said it will voluntarily stop all promotion of the drug in the countries in which it operates. The news came after the London stock exchange closed, although GSK shares fell 1% to £12.59 along with a downturn in other drug issues. In the USA, American Depository Receipts were down 1.8% at $39.43 at close.

The EMEA yesterday recommended the suspension of the marketing authorizations for the rosiglitazone-containing anti-diabetes drugs marketed under the brand names Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months, the Agency said, however making it clear that patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor.