Cholesterol lowering drug, Crestor Linked to Patient Death

Cholesterol lowering drug, Crestor Linked to Patient Death

Tue, 11 Jan 2005

Crestor, a highly advertised cholesterol-lowering drug in the statin class–as was Bayer’s drug Baycol, which was withdrawn from market after 30 patients died of rhabdomyolysis (breakdown of skeletal muscle fibers), has been linked to a patient’s death.

“AstraZeneca confirms that a death possibly attributed to rhabdomyolysis associated with Crestor has been reported. The case details are complex, with clinical features more consistent with neuroleptic malignant syndrome, a condition seen with antipsychotic agents.” Both of these drug-induced toxic conditions lead to acute renal failure.

The dirty secret is out: new drugs are being approved before their lethal side effects have been revealed at the testing stage because the clinical trials are not designed to detect rare but lethal side effects that surface with extended use of the drugs. Clinical trials continue to follow the template that was appropriate for testing antibiotics which are taken for short periods, not chronic use.

Thus, one may legitimately classify newly approved rugs as still in the experimental stage, and FDA’s approval can be considered provisional. Therefore, drugs whose safety is still in doubt, should not be advertised, lest many people will be exposed to lethal effects.

The Alliance for Human Research Protection calls, therefore, for a moratorium on drug advertising – at least for 7 years from the date of FDA’s approval.

Contact: Vera Hassner Sharav
212-595-8974

http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=7282624&section=news&src=rss/uk/healthNews

Mon Jan 10,11:57 AM ET
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON (Reuters) – AstraZeneca Plc’s cholesterol-lowering drug Crestor has been linked to the death of a patient who developed a suspected case of severe muscle wasting, Europe’s third largest drugmaker said on Monday.

The news will increase uncertainty about the future of the medicine, whose safety record has been attacked by critics.

Company spokesman Steve Brown said the death may have been due to a condition known as rhabdomyolysis and the incident had been reported to regulators worldwide.

But the circumstances surrounding the death, in the latter part of 2004, were complicated and the company still believed Crestor’s safety profile was similar to that of other so-called statin drugs, he added.

Shares in AstraZeneca fell as much as 2.5 percent on news of the death but pared losses to stand just 0.1 percent lower at 19.36 pounds by 1620 GMT.

Brown declined to say where the death occurred or what dose of Crestor the patient had been taking.

“AstraZeneca confirms that a death possibly attributed to rhabdomyolysis associated with Crestor has been reported. The case details are complex, with clinical features more consistent with neuroleptic malignant syndrome, a condition seen with antipsychotic agents,” Brown said in response to inquiries.

Muscle problems have been associated with all statins used to tackle high cholesterol and AstraZeneca noted more than 14 million prescriptions had been written for its medicine worldwide. This is the first suspected fatal case of rhabdomyolysis associated with Crestor.

Crestor is the Anglo-Swedish company’s most important new drug and has been viewed by analysts as a potential $3 billion-a-year seller.

But the product has been dogged by allegations over its safety. Veteran U.S. Food and Drug Administration official David Graham last November named it among five medicines on the market that needed closer safety scrutiny.

U.S. consumer group Public Citizen has also repeatedly called for it to be banned, because of the threat of rhabdomyolysis — a condition in which muscle fibres break down and are released into the circulation, damaging the kidney.

DETERRENT

Industry analysts said the Crestor death would be a further deterrent for doctors and patients, and would increase the risk it might eventually be pulled from the market.

Tim Anderson of Prudential Securities in New York said Schering-Plough Corp and Pfizer Inc, makers of rival anti-cholesterol treatments, should benefit from the latest safety concerns.

Crestor and other so-called statins belong to the same family of drugs as Bayer AG’s Baycol, which was pulled from the market in 2001 after being linked to dozens of deaths.

But AstraZeneca said the circumstances surrounding Crestor were quite different, since Baycol was associated with more than 30 rhabdomyolysis-related deaths from a patient exposure of less than 10 million prescriptions.

Industry analysts said the AstraZeneca stock, which has fallen 28 percent on a series of product setbacks since September, could now be underpinned by takeover speculation.

Deutsche Bank earlier on Monday became the latest securities house to suggest that larger British rival GlaxoSmithKline Plc might be interested in acquiring the business to boost its presence in cardiovascular and cancer medicine.

GSK shares were off 1 percent at 12.38 pounds. (Additional reporting by Alison Tudor)

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