Acetaminophen Warning on Rare Skin Reaction Issued by FDA

Image: Acetaminophen Warning on Rare Skin Reaction Issued by FDA NyQuil, left, Tylenol, center front, and Theraflu, right, all containing acetaminophen.

Monday, 05 Aug 2013 10:17 AM

By Alexandra Ward

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Acetaminophen, the widely used fever and pain reducer commonly found in over-the-counter medications like Tylenol, can cause rare but fatal skin reactions, the Food and Drug Administration warned Thursday.

The ingredient has been linked to Stevens-Johnson Syndrome and toxic epidermal necrolysis, according to the FDA, which said medication labels will now carry a warning about the possible skin complications.

"This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications," Dr. Sharon Hertz, deputy director of FDA's Division of Anesthesia, Analgesia, and Addiction, said in a written statement. "However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal."

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The skin reactions start with flu-like symptoms such as a fever and muscle aches, followed by a rash that blisters and causes the sloughing off of the outer layer of skin, leaving a person vulnerable to deadly infections, Time reported.

Consumers who notice skin symptoms after taking acetaminophen should immediately stop taking it, the FDA and medicine manufacturers said.

"As the makers of Tylenol (acetaminophen), we take seriously all matters related to our products and are committed to providing consumers with safe and effective medicines," Tylenol-maker McNeil Consumer Healthcare said in a statement. "Consumers should stop using medications and ask their doctor whenever they have new symptoms."

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A Massachusetts teenager and her parents were awarded $63 million in February after the girl nearly died from a case of toxic epidermal necrolysis she got from taking Motrin. The girl, Samantha Reckis, lost 90 percent of her skin, was blinded, and suffered brain damage that caused short-term memory loss. She was placed in a medically induced coma and required skull surgery to relieve some pressure, and the reaction also spread to her respiratory system, taking most of her lung capacity, according to CBS News.

Related stories:

Pain Drugs to Carry More Prominent Warnings

NY Sen. Schumer Warns FDA on Danger of Newest Painkillers

FDA Pulls Darvon Painkiller Due to Safety Risks  

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