Patients Question Statins’ Safety After FDA’s New Label Warnings
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iStockphoto/Thinkstock(WASHINGTON) — A growing number of physicians may find patients questioning the safety of statins following the U.S. Food and Drug Administration’s announcement Tuesday that it would require additional safety warnings on the labels of the cholesterol-lowering drugs.
Doctors have said that while the benefits of statins outweigh their potential harm, some patients are alarmed by the new announcement.
“This news will make the care of my patients more difficult and less effective,” said Dr. Richard Honaker, a physician with the Family Medicine Associates of Texas in Carrollton.
Honaker said that he has already had a patient who has been reluctantly taking the statin drug Lipitor now tell him he will quit the medication after reading about the new warning labels.
“Some patients are always reading up on their medications on the Internet, and it seems like they only read the negative and not the positive,” said Honaker. “It’s going to be an uphill battle.”
Statins — more commonly known by the brand names Lipitor, Crestor and Zocor — inhibit the enzyme that plays a big part in the liver’s production of cholesterol.
The FDA now requires that statin labels include warnings about the rare but serious risk of liver damage, memory loss and confusion, and type 2 diabetes. Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.
Many experts, including Honaker, said the side effects listed are rare and mild.
“There’s gigantic data showing that you’ll live longer and healthier,” said Honaker.
The decision came following an internal meeting between the FDA’s Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA’s deputy director of safety in the division of metabolism drug products.
Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year. She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.
“We can’t establish causality with statin therapy,” said Egan, regarding the new warnings.
Also, most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear. Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.
Copyright 2012 ABC News Radio