FDA Orders Acetaminophen Warning

FDA Orders Acetaminophen Warning

August 7th, 2013 // 12:06 pm @

Latest FDA and cGMP Compliance News

Acetaminophen, which is the pain and fever reliever that is used in Tylenol, can cause serious skin problems and reactions in some people, FDA stated this month. The drug has now been linked to several specific skin problems and diseases: Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis.

Stevens Johnson syndrome is a serious skin disorder that can make your top skin layer die and fall off. It can be mortal in some people, so any symptoms of rash, blisters and pain must be treated quickly. Toxic epidermal necrolysis is similar to the previous disease, and it causes blisters on much of your body. It also can cause the mucus membranes to react, which is especially common around the eye. Many people who have this disorder begin with conjunctivitis.

Acute generlized exanthematous pustulosis is the least serious of the diseases, with prognosis being excellent, according to NIH.

FDA wants to stress that the occurrence of all of these skin reactions is very rare, but that people who take the drug should notice any changes in the condition of their skin after they use acetaminophen.

FDA noted that the information is not supposed to worry either consumers or health professionals, and it is not supposed to encourage them to select other drugs. However, it is important that everyone recognize and react to any symptoms of these rare but very serious skin disorders.

The Wall Street Journal reported that FDA had discovered 107 cases of serious skin problems that was caused by acetaminophen use from 1969 to 2012. Of those cases, 12 died and 67 were put in the hospital, where they were treated successfully.

This is not the first case where acetaminophen was linked to a major health risk. In 2011, FDA determined there was a link between liver damage and using the drug.


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