FDA warns of acetaminophen causing severe skin reactions
© 2013 Roy Benaroch, MD
I’ve said in many times here, but it’s worth saying again: any medicine (any real medicine, let’s leave placebos out of this) can cause adverse reactions, and sometimes serious adverse reactions. Even good old Tylenol (acetaminophen), said the FDA in a warning this week.
It’s not time to panic. Serious skin reactions to acetaminophen are really, really rare—the FDA’s warning mentioned 107 serious skin reactions, including 12 deaths, from 1969 to 2012. Considering that millions of doses of acetaminophen are given to children yearly, your child’s risk of this kind of reaction is miniscule.
Still, acetaminophen, like any other drug, really should only be used if needed. It’s great for reducing fever—but that’s really only necessary if the child isn’t feeling well. Fever itself is harmless. But I do recommend using acetaminophen (or ibuprofen after age 6 months) is a child with a fever feels sick and uncomfortable. Acetaminophen is also effective for treating pain, and can safely and effectively be given even before painful experiences, or regularly for a few days when you know there is going to be pain.
About those skin reactions: almost any drug can rarely cause serious skin reactions that can lead to significant skin loss, almost like a large burn. These reactions are probably more common with anti-epilepsy medications and some antibiotics (like Bactrim), though even then they’re quite rare. Still, the most important steps are to 1) avoid medication unless it’s needed; and 2) if there is a worrisome rash, stop taking the medication. The medicine-rashes that are most serious include blistering or painful skin, or reactions that include the lips or eyes, or any widespread rash that’s worsening. If your child has a rash on a medication, contact the prescribing doctor’s office to discuss what you’re seeing and whether stopping the medication is needed. When in doubt, it’s usually best to stop the medicine—though of course that depends on what the medication is for. Call or see your own doctor for advice.
Even though it’s overall a very safe and useful medications, there are other rare problems with acetaminophen. Even relatively small overdoses can cause severe liver toxicity, especially in those with pre-existing liver disease. And there are some links to the use of acetaminophen and asthma (though this is still unclear.)
The FDA is going to require a warning about these skin reactions on all prescription medicines containing acetaminophen, and will “request” that manufacturers include this warning on over-the-counter preparations. That label is going to get crowded!