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FDA Mulls Easier Access to Cholesterol Drugs

"In our view, given patient monitoring and safety issues, it is unclear whether or not any statins will go OTC," said David R. Risinger of Merrill Lynch. Mevacor will be reviewed in January by the adviser panels on nonprescription drugs and on endocrine and metabolic drugs.

Statins will have a tougher time being converted to nonprescription status than heartburn drugs, such as Prilosec, and antihistamines, such as Claritin, Risinger said. These drugs treat "generally benign conditions," and patients can tell when to start taking the drugs and when to stop, he said. But elevated cholesterol doesn't produce obvious signs, requiring physician monitoring and lab tests. Some statin-linked side-effects can be life-threatening, he added, but "such major adverse events are generally not an issue" with the heartburn drugs and antihistamines.

Risinger said doctors view newer statins as superior to older drugs. Even if Mevacor and Pravachol go OTC, "a majority" of physicians will initially write prescriptions for brand-name drugs "and rarely switch to an OTC unless access is limited by an individual's insurer," he said.

A Different Climate

Bringing up the subject of OTC statins comes at an awkward time, given the continuing scrutiny over the FDA's behavior in such matters as Merck's withdrawal of the arthritis drug Vioxx and Chiron's (CHIR) discovery at literally the last minute that manufacturing problems would kill off its entire supply of flu vaccine for this season.

The agency also has taken criticism for some statins. Baycol was pulled off the market in 2001 by Bayer (BAY) because the drug was linked to some 31 deaths, according to the FDA. The drug, which entered the U.S. market in 1997, had a high rate of the rare muscle-wasting disease called rhabdomyolysis.

In addition, AstraZeneca's (AZN - Get Report) Crestor, approved by the FDA in August 2003, has been criticized by Public Citizen, a U.S. consumer group, and by The Lancet, a leading British medical journal, for what they say are high rates of certain side-effects. Both want the drug withdrawn. AstraZeneca defends Crestor, pointing to clinical trials and comments from top-ranking FDA officials that the drug is safe.
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