Cholesterol Drug Warning Labels Issued by FDA to Prevent Memory Loss
Federal health officials plan to add new safety warning labels to drugs that specialize in lowering people's cholesterol.
Dangerous side effects caused by some of these drugs include memory loss and elevated blood sugar, both of which will be stated in the new labels.
Drugs that will receive the new warnings include medicines such as Pfizer Inc's Lipitor. AstraZeneca's Crestor and Merck & Co. Inc's Zocor. All these drugs help tens of millions of Americans to keep their cholesterol at on optimum level daily.
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All these drugs are considered to be statins that have been shown to significantly reduce the risk of heart attack and heart disease. The FDA does not want to scare people by issuing these warnings, but rather inform them on some of the possible side effects.
"The value of statins in preventing heart disease has been clearly established," said Amy Egan, deputy director for safety in FDA's Division of Metabolism and Endocrinology Products in a recent statement. "Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects."
Lipitor is currently the world's all-time biggest selling prescription medicine with cumulative sales in excess of $130 billion thanks to the addition of a generic version known as atorvastatin.
"These nuances, tiny little tweaks to the label, and the bigger picture doesn't change," said Steven Nissen, chief of cardiology at Cleveland Clinic to CNBC. "There are few drugs that have saved as many lives as statins and we don't want to throw the baby out with the bathwater here."
"If you have heart disease, you probably should be on a statin. If you're at high risk, a stating maybe warranted," he continued. "But we don't think these drugs should be put in the water supply."
The FDA's decision to issue the labels came after the agency's review of medical literature, clinical trial data and reports of adverse events, according to FDA spokeswoman Erica Jefferson.
