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FDA: Acetaminophen may Cause Serious Skin Reactions

Earlier this month, the Food and Drug Administration (FDA) issued a consumer warning to help increase awareness of a number of rare skin conditions that may erupt as a reaction to acetaminophen.

Available over-the-counter or at prescription strength, acetaminophen is the active ingredient in Tylenol, though there are many generic distributors of acetaminophen, as well. The drug is also commonly combined with other medications such as formulas used to treat colds, allergies, cough, headaches, and insomnia. Acetaminophen is also used in combination with opioids for prescription-strength pain relief.

The FDA lists three potential skin conditions which could result from use of acetaminophen, even at an over-the-counter dosage: Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Stevens-Johnson syndrome presents as a painful, blistering rash and often needs to be treated in hospital burn units. Toxic epidermal necrolysis is a similar condition that causes blisters to cover much of a patient’s body. Acute generalized exanthematous pustulosis is also a rash, but is far less serious than the two previously mentioned conditions, which have proven fatal in some cases.

The deputy director of the FDA’s Division of Anesthesia, Sharon Hertz, M.D. underscores that this announcement is not intended to cause alarm, but rather to educate American consumers. “This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications. 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.”

The FDA will now require that all prescription drugs containing acetaminophen carry warnings of these skin conditions, and the agency intends to work with the makers of over-the-counter acetaminophen products to update those warning labels, as well.

According to the personal injury lawyers at Berkowitz and Hanna LLC, if you or someone you love has been diagnosed with Stevens-Johnson syndrome or another rare skin condition that may be linked to use of acetaminophen, you could be entitled to compensation. To learn more about Stevens-Johnson syndrome lawsuits, contact us to schedule a consultation.