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Lipitor Safety Questioned in Lawsuit

Lipitor Lawsuits Claim Pfizer Failed to Warn of Cholesterol Drug's Rare Dangers
By
WebMD Health News
Reviewed by Louise Chang, MD

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.

Pfizer is a WebMD sponsor.

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.

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Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

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