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Drugs authorisation: what's the rush?

It is in patients' best interests for drugs to be properly evaluated before being put on the market.

Some drugs are given a marketing authorisation too quickly. In the case of the anti-coagulant drug melagatran/ximelagatran, the marketing authorisation was granted in France and Europe, despite worrying signals that it could cause hepatic and cardiac toxicity, and that it did not represent a therapeutic advance. A few months after approval, in February 2006, the drug was withdrawn from the market when the hepatic risk was confirmed. It had not been given a marketing authorisation in the USA.

In practice, it appears that the regulatory agencies' priority is to please pharmaceutical companies. Companies want access to the market as quickly as possible, even if that means postponing research into optimum indications, or withdrawing the drug from the market when too many patients have suffered from this unseemly haste -- which goes against patients' interests.

©Prescrire May 2006

Source: "Précipitation" Rev Prescrire 2006 ; 26 (271) : 244.

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