Lipitor Safety Questioned in Lawsuit

June 9, 2006 - Lawsuits filed this week claim that drug-maker Pfizer has failed to warn doctors and patients about serious possible side effects of the cholesterol-lowering drug.

The two lawsuits claim that Lipitor caused lasting, debilitating muscle and nerve problems -- including memory loss. Mark Jay Krum, a lawyer based in New York and Philadelphia, last Wednesday filed the suits in New York State Supreme Court on behalf of patients in New York and Atlanta.

Charles M. Wilson, a 60-year-old Atlanta man, says taking Lipitor damaged his nervous system. Three years after he stopped taking Lipitor, the suit says, his feet and hands burn, his balance is lost, and he suffers bouts of fatigueand memory loss.

The suit filed by Michael Mazzariello, a 47-year-old New Yorker, says his use of statins -- the family of cholesterol-lowering drugs to which Lipitor belongs -- left him with debilitating muscle damage and extensive memory loss.

"The complaint alleges that Pfizer promoted Lipitor as a safe drug with minimal health risks while failing to warn doctors and patients about Lipitor's more dangerous side effects," Krum tells WebMD. "No one is saying Lipitor does not work in reducing cholesterol. In most people it may be safe. But there are side effects such as those in the complaints filed on June 7. People are entitled to know."

With annual sales of about $12 billion, Lipitor is the world's best-selling medicine. It's the most popular of the cholesterol-lowering drugs called statins. Other statins include Zocor, Crestor, Mevacor, Pravachol, and Lescol. A statin drug called Baycol was removed from the market in 2001 because it caused far more cases of muscle damage than other members of its class.

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Pfizer: Lipitor Safe, Allegations False

Pfizer spokesman Bryant Haskins says that while Lipitor is among the world's safest drugs, it can -- rarely -- cause serious side effects. And the company, he says, makes these risks perfectly clear to doctors and to patients.

"This is an extremely safe drug. It is the most studied drug in the world," Haskins tells WebMD. "It has been studied in over 400 clinical trials with 80,000 patients. More than 20 million patients have taken the drug since it entered the market about a decade ago. Any potential side effects, any significant adverse events are on the drug's label, in our advertisements, and on our web site. To say we have hidden information on this drug is absolutely false."

Lipitor has two major kinds of side effects, says Richard Milani, MD, head of preventive cardiology at the New Orleans-based Ochsner Clinic Foundation. A prominent cardiologist, Milani serves on the speakers' bureau for Pfizer and other companies that make statin drugs but has no other ties to the companies.