EMEA suspende DEPRANCOL (Pfizer/Parke Davis)

By JEANNE WHALEN

Europe's main medical regulator recommended that a 50-year-old painkiller, already largely ordered off shelves in some places, be withdrawn from the European market out of concern that patients have been fatally overdosing from it.

The drug is known by the generic names dextropropoxyphene in Europe and propoxyphene in the U.S. It is still on the market in the U.S., where the Food and Drug Administration is considering whether to withdraw it.

The drug is an opioid that is widely used to treat mild to moderate pain. It was first introduced in the U.S. in 1957 by Eli Lilly & Co., under the brand name Darvon. Today it is marketed by a variety of generic-drug makers. Critics of the drug have been trying to have it withdrawn from the market for years.

The European Medicines Agency, or EMEA, said a "significant" number of Europeans have died by overdosing with the drug, either accidentally or intentionally. An EMEA official didn't respond to a request for clarification on how many people have died.

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La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha emitido una comunicación sobre riesgos de medicamentos (Ref 2009/08) en la que informa de la propuesta de suspensión de comercialización de dextropropoxifeno (Deprancol^®) en Europa. Tras una revisión de los datos de eficacia y seguridad de este fármaco, el Comité de Medicamentos de Uso Humano (CHMP) de la Agencia Europea de Medicamentos (EMEA) ha concluido que el balance beneficio/riesgo es desfavorable; dextropropoxifeno no presenta mayor eficacia respecto a otros tratamientos alternativos, mientras que datos procedentes de registros de mortalidad de Estados Miembros muestran un número significativo de muertes por sobredosis (en España no se ha registrado ningún caso, siendo otro claro ejemplo de actuación conjunta de las administraciones europeas).

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