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Home Health First Aid FDA Warning On Over-The-Counter Painkillers

FDA Warning On Over-The-Counter Painkillers

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FDA WARNINGWhether you’ve overdone it in your workout or the night before at a party, many people will pop a few pills for the pain. Common over-the-counter pain relievers, called non-aspirin non-steroidal anti-inflammatory drugs known as NSAIDS are now under fire by the U.S. Food and Drug Administration.

The FDA issued, what it calls a drug safety communication, saying the labels must include, "the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. The risk appears greater at higher doses."

These types of pain relievers are typically used for muscle pain, headaches, flu, and even menstrual cramps. But higher doses require a prescription. Bayer (manufacturer of Aleve) released a statement to CNN saying: "When taken as directed on the label, Aleve (naproxen sodium 220 mg) is a safe and effective pain reliever, used by millions of consumers since its introduction as an OTC product 20 years ago. Importantly, data collected for nearly 20 years indicates no signal (i.e. trend) for OTC naproxen sodium with regard to the occurrence of (cardiovascular) thrombotic and overall (cardiovascular) events."

Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, says "What patients need to know is, if you take the drugs, 'What is my risk of heart attack?' and that's not known yet," His advice, "take these at the lowest dosages for the least amount of time that relieves symptoms."

The FDA advises patients who experience shortness of breath, chest pain, sudden numbness or weakness, or sudden slurred speech to seek immediate medical attention. Other side effects should be reported to the agency.


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