MHRA Withdraws Painkiller Co-Proxamol Due to Safety Concerns

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) recently initiated a phased withdrawal of painkiller co-proxamol, the agency announced.

The recall came amid evidence that co-proxamol, a combination of dextropropoxyphene and paracetamol, is associated with up to 400 international and accidental overdoses annually. MHRA's Committee on Safety of Medicines (CSM) has been reviewing the safety of co-proxamol since 1985, and the agency stepped up that review April 2004 when it issued a renewed call for evidence on the risk and benefits of the drug.

MHRA has taken steps in the past -- such as labeling revisions -- to raise awareness about the risks associated with co-proxamol, but they have been ineffective, the agency said.

"While the risks of co-proxamol are well-known to health professionals, the latest evidence is that the measures to strengthen the labeling of co-proxamol have been ineffective in reducing the high fatality rate involving both intentional and accidental overdose," MHRA Chairman Alasdair Breckenridge said. "The MHRA and CSM have considered further evidence gathered during a public request for information on the risks and benefits of co-proxamol and have decided that the benefits of the continued availability of co-proxamol do not outweigh the risks and that co-proxamol should be withdrawn from the market."

Co-proxamol is an analgesic used to treat mild-to-moderate pain. It is not approved in the U.S.