UK Regulators Expressed Worries Over Crestor® 40mg

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Experts at the UK's medicine regulator expressed serious worries over high doses of the controversial cholesterol-lowering drug Crestor® just two months before it went onto the market, confidential documents seen by the Guardian reveal.

Their concerns were overruled by a European-wide decision to allow the high dose, 40mg, on the market.

Minutes from meetings of UK's Medicines and Healthcare products Regulatory Agency (MHRA) reveal that it had seen higher rates of dangerous muscle-wasting disease, called rhabdomyolysis, in patients on Crestor® compared with other statins.

This prompted a change in the recommendation of the drug, last June, to restrict the 40mg dose to extreme cases, and ensure patients start on the 10mg dose.

The original advice from experts on the Committee on Safety of Medicines (CSM), the body that decides a drug's fate within the MHRA, said the 40mg dose should not go on the market.

The confidential minutes show that, since December 2003 at least, the UK regulators have been concerned that there is a "signal" of higher rates of rhabdomyolysis. They say this could be due to the drug being more toxic or a number of other reasons.

The 40mg does is still on sale in the U.S., where there has been a long-running campaign to ban Crestor® by the lobby group Public Citizen.

The minutes of the MHRA and the CSM related to the safety of high dosages of Crestor® were obtained by a request from the Guardian under the Freedom of Information Act.

If you believe that you or a relative were injured by taking Crestor® please use the form below to contact our law firm.

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