The European Medicines Agency Thursday suspended marketing authorization for GlaxoSmithKline PLC’s (GSK) controversial diabetes drug rosiglitazone saying the risks of taking the drug don’t outweigh its benefits and that the medicines containing it will stop being available in Europe within the next few months.
The EMA — the decentralized European body responsible for licensing rosiglitazone in 2000 and which held an extraordinary expert meeting earlier this month to review the drug’s safety — said in a statement that “the availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk” from the drug.
The regulator said it therefore decided that “the benefits of rosiglitazone no longer outweigh its risks” and recommended the suspension of the marketing authorization of the medicines.
The decision affects the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim.
Pressure has increased for the London-based European body to pull the drug, which has been linked to heart failure, after U.K. regulators this month said the risks from taking Avandia were greater than the benefits. The Medicines and Healthcare products Regulatory Agency (MHRA) said it believed the risks of rosiglitazone outweighed its benefits and that “it no longer has a place on the U.K. market.”
Full story here at the Wall Street Journal