FDA condemns AstraZeneca over Crestor newspaper ads

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The US marketing campaign launched by AstraZeneca to defend the safety of its controversial anti-cholesterol medicine Crestor has backfired in spectacular fashion, as the Food & Drug Administration, the regulator, condemned its newspaper advertisements as misleading.

The US marketing campaign launched by AstraZeneca to defend the safety of its controversial anti-cholesterol medicine Crestor has backfired in spectacular fashion, as the Food & Drug Administration, the regulator, condemned its newspaper advertisements as misleading.

The company took out the ads last month after an FDA scientist, David Graham, raised safety concerns over the drug, which can cause muscle wasting in rare cases. Public Citizen, a consumer group, wants the drug withdrawn, and Crestor's market share has tumbled.

The ads pointed to the FDA's official statement repudiating Dr Graham's views, but the FDA saysthey went too far in suggesting the regulator had dismissed the concerns over Crestor's side effects.

In a warning letter to the company, the FDA quotes the acting director of its centre for drug evaluation, Steven Galson, saying: "The agency has been very concerned about Crestor since the day it was approved and we've been watching it very carefully." AstraZeneca has been told not to re-run the ads, which suggested Crestor was "safer than has been demonstrated", it said.

The company's shares hit a 21-month low yesterday. It needs Crestor to be a blockbuster drug after the failure of two of its drugs in quick succession this year.

AstraZeneca said the ad was a one-off, printed in response to Dr Graham's comments and was no longer being published.

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