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Home / FDA Warns of Rare Skin Reactions Associated...

FDA Warns of Rare Skin Reactions Associated with Acetaminophen

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FDA Acetaminophen Warning

The U.S. Food and Drug Administration released a Safety Communication warning that acetaminophen has been associated with the risk of a serious skin reaction.  The reaction, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) is sometimes fatal.

Symptoms Associated with Acetaminophen Reaction

Symptoms of the skin reaction include:

  • Reddening of the skin
  • rash
  • blisters
  • detachment of the upper surface of the skin

Symptoms can occur with first-time use of acetaminophen or at any time during treatment.  Other drugs known carry the risk of causing serious skin reactions carry the warning on their drug label.

Acetaminophen is a common active ingredient used to treat pain and reduce fever.  It is sold in many over-the-counter products, as well as prescription medications.

FDA Acetaminophen Safety Requirements

The FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen.  The agency will also request that manufacturers add a warning about serious skin reactions to the product labels of over-the-counter acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the same.

If you or someone you know has been injured by acetaminophen, call Longo Legal, PLLC to find out if you have a potential claim. The first step is to get some preliminary information over the phone. The initial phone call and consultation cost you nothing. You will not pay Longo Legal, PLLC anything towards your Acetaminophen lawsuit unless a recovery is made on your behalf. Call Longo Legal at (855) 566-4648 to see if you qualify.

View the full FDA Safety Communication here.

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