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FDA Links Acetaminophen to Rare, Fatal Skin Problems

Acetaminophen is a common, active ingredient in many of the painkillers that are most frequently taken by individuals who are looking for quick relief from a headache, sprain, or other pain-inducing malady. The ingredient has been so effective in the results that it delivers that for years acetaminophen has been included in some of the nation's most popular pain-relieving drugs. Products such as Tylenol (Johnson & Johnson), Advil (Pfizer Inc.) and Bayer AG all contain more than just trace amounts of acetaminophen. However, new findings about the pain-relieving ingredient could quickly change the way that both medical professionals and consumers view drugs that include this ingredient.

A recent study conducted by the Food and Drug Administration (FDA) has recently revealed that serious skin reactions such as blisters and rashes have been linked to use of drugs that contain the active acetaminophen ingredient. In a review of the FDA's "adverse events" database, documented reports of strong and adverse reactions to the use of medications that contain acetaminophen were revealed. The FDA is now warning individuals who develop any sort of serious skin reaction in conjunction with the use of an acetaminophen-containing product to immediately seek medical treatment. Rare reactions to the drug have resulted in hospitalization and death.

According to findings from the FDA, most of the reported reactions to the pain-relieving ingredient have come from single-ingredient acetaminophen products. In a search of the FDA's "adverse event" database, a total of 107 cases of skin conditions were found between the years of 1969 and 2013. Three types of skin conditions have been identified with the use of acetaminophen, both in single-ingredient drugs and combination-ingredient drugs such as those that also contain codeine and / or oxycodone. Also included in the FDA's findings were the following statistics:

  • 107 cases of 3 different kinds of skin conditions
  • 67 hospitalizations from these skin conditions
  • 12 deaths from these skin conditions
  • 91 cases of Stevens-Johnson Syndrome and toxic epidermal necrolysis
  • 16 cases of acute generalized exanthematous pustulosis

The serious side effects that can result from use of acetaminophen are not limited to skin rashes. Approximately two years ago, incidents of liver injuries were linked back to the ingredient as well, at which time the FDA took immediate action. Now, all prescriptions that contain acetaminophen are required to carry a boxed warning of the risk of liver injury, and these prescription products must be limited to no more than 325 milligrams of the ingredient.

To date, more than 600 different medications include the acetaminophen ingredient, and millions of individuals throughout the United States have been taking medications that include acetaminophen in order to treat pain and fever for decades on end. If your or someone you love unduly suffered from taking a product that contains acetaminophen, please do not hesitate to speak with a California defective drug lawyer from The Senators Firm. Our experienced team of legal professionals can help you seek legal recompense for your pain and suffering.

Categories: Defective Drugs
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