Chemistry and Industry - Safety concerns over Crestor
There have been questions over the safety of Crestor, the cholesterol drug on which AstraZeneca has pinned most of its hopes for future growth.
US patient group Public Citizen has asked the US Food and Drug Administration (FDA), to withdraw the drug, following the death of a patient who suffered from a muscle damaging condition called rhabdomyolysis, Baycol, Bayer’s successful cholesterol-fighting drug, was withdrawn from the market in 2001, when it was linked to dozens of rhabdomyolysis-related deaths worldwide.
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A 30-year old woman is reported to have died from kidney failure and rhabdomyolysis. Other patients have experienced similar side-effects. In the wake of the Baycol crisis, Crestor’s entry to market was delayed by almost a year, as the FDA demanded studies showing Crostor to be safer or more effective than existing statins.
However, AstraZeneca stands by its product, stressing that it was the most extensively studied drug in its class, with more than 40 000 patients involved in clinical trials and more than one million patients using the drug.
‘Public Citizen’s comments are nothing new,’ said a spokesperson. ‘AstraZeneca monitors the postmarketing adverse events, reports intensively and dedicates intensive efforts to follow up reports and evaluate individual cases.’
Meanwhile, French healthcare authorities have decided that Crestor should be covered under the country’s health service, but only after treatment with other statins. AstraZeneca points out that the same advice was originally given for Pfizer’s market-leading statin Lipitor.
AstraZeneca’s shares seemed unaffected by the news.
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