AstraZeneca faces US call for Crestor inquiry

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The Independent Online

A high-profile consumer campaign to have AstraZeneca's new anti-cholesterol pill banned in the US escalated dramatically yesterday, when the UK pharmaceutical giant was accused of suppressing details of potentially fatal side effects.

A high-profile consumer campaign to have AstraZeneca's new anti-cholesterol pill banned in the US escalated dramatically yesterday, when the UK pharmaceutical giant was accused of suppressing details of potentially fatal side effects.

Public Citizen, the consumer protection group set up by the US presidential hopeful Ralph Nader, demanded that AstraZeneca faces a criminal investigation for delaying the publication of 23 cases of serious side effects from taking Crestor. The company lashed out at Public Citizen, describing the group's claims as "one more false, misleading, inaccurate report", and insisted that it had complied with all the laws regarding disclosure of side effects.

Patients are warned that in rare cases Crestor, the latest in a class of drugs known as statins, can cause a potentially fatal muscle-wasting disorder or kidney failure. However, it has been approved in most Western countries, including the UK, because the benefits of reducing cholesterol have been judged to outweigh the risks.

The Food and Drug Administration, which approved the product in the US and which is monitoring its safety, requires that unexpected side effects are reported within 15 days.

Public Citizen alleges that it has identified 19 cases of muscle deterioration and four of kidney failure among Crestor patients which should be classified as "unexpected" because they occur on low doses of the drug, but which were only reported in AstraZeneca's quarterly update to the FDA.

In a letter to the FDA, Public Citizen's health research director, Sidney Wolfe, wrote: "These intentional reporting delays by AstraZeneca, while temporarily succeeding in making their drug appear safer than it actually is, have unquestionably impaired the FDA's ability to promptly assess the safety of this uniquely dangerous drug."

The company says the cases were not "unexpected" because they were known side effects. "AstraZeneca's highest priority is patient safety," it said in a statement. "The company has operated diligently in accordance with the strict reporting procedures of the FDA. There is a global safety database for Crestor that continues to confirm a safety profile that is comparable to that of other marketed statins."

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