LONDON, England (AFP) — The European Medicines Agency (EMA) said yesterday that diabetes drug Avandia would no longer be available to patients in Europe after recommending that it be removed from the market due to health concerns.
Avandia “will stop being available in Europe within the next few months”, the EMA said in a statement.
The announcement came as the US Food and Drug Administration (FDA) decided to severely restrict the use of Avandia, made by British company GlaxoSmithKline, but stopped short of an outright ban.
Avandia has long been associated with an increased risk of heart attack and stroke, and an FDA study in 2007 linking the medication to serious health concerns prompted authorities to slap a warning on it.
The EMA meanwhile said it had taken the decision to pull the drug in Europe due to concerns over the drug’s active substance rosiglitazone.
It decided also to halt the sale of Glaxo’s other diabetes drugs, Avandamet and Avaglim, since they too contained rosiglitazone.
“The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim,” said a statement.
“These medicines will stop being available in Europe within the next few months. Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments.”
GlaxoSmithKline said it believed Avandia remained an “important treatment” and was working with the EMA and FDA to try and find a solution to the concerns.
The EMA said the Europe-wide suspension would remain unless there was “convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks”.
The FDA said that its move to restrict the sale of Avandia came amid “data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated” with the drug.
Under the restrictions, Avandia will be available to new US patients with Type 2 diabetes only if they are unable to control their glucose levels through other medications.
Existing diabetes sufferers taking Avandia will be allowed to continue to take the medicine if they so choose, the FDA statement said.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA commissioner Margaret Hamburg.
“We are seeking to strike the right balance to support clinical care.”