FDA Issues Warning Of Potentially Fatal Skin Reaction To Tylenol

In the United States, when you want to feel better, you take a Tylenol. This over the counter pain reliever is one of the best selling non-prescription products in the world. Invented in the 1950's as an alternative to Aspirin that can be taken on an empty stomach, acetaminophen (known as paracetamol outside the USA) is taken by billions of people who buy it under the trade names Tylenol, Alvedon, Anacin Aspirin Free, Apra, Crocin, Dafalgan, Doliprane, Efferalgan, Febrecet, Feverall, Genapap, Lekadol, Panodil, Panodol, Uphamol, Vermidon, Vitamol, Xumadol, and Zolben, among dozens of others.

Potentially Fatal Skin Reactions

The use of Tylenol has been associated with three potentially deadly skin reactions known as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. All three skin conditions are recognized by rash, reddening of the skin, formation of blisters, and detachment of the upper layer of the skin. Some people are at greater risk than others at developing these severe reactions to the drug

• Acute generalized exanthematous pustulosis, also known as the id reaction or autoeczematization, is a body-wide condition of oozing and blistering that is generalized by the immune system. It typically appears in people who already have a severe skin infection. The use of Tylenol for pain relieve may push the inflammatory process "over the edge" so that a generalized skin reaction occurs.

• Stevens-Johnson syndrome most often occurs in people who have HIV, in people who are getting radiation treatment for brain tumors, and in people who are labeled as "slow acetylators," that is, who lack a particular kind of detoxification enzyme in the liver that breaks down the active ingredient in Tylenol and in other medications. People who get Stevens-Johnson syndrome most often would be taking a number of drugs in addition to Tylenol which "max out" the ability of their bodies to detoxify drugs.

• Toxic epidermal necrolysis is a potentially fatal skin reaction to certain antibiotics, seizure medications, and drugs for gout. Tylenol is not the only non-prescription pain reliever that can trigger an attack of this condition. Ibuprofen and Indomethacin can cause similar reactions.

You aren't likely to have a near-fatal reaction to Tylenol if you aren't already sick. However, because a few people have developed these symptoms without having a pre-existing disease and even after their first few doses of the pain reliever, the FDA urges anyone experiencing blisters while taking Tylenol or any other form of paracetamol to stop taking the product immediately and see a doctor.

Other Potential Problems with Tylenol

Dangerous skin reactions are not the only potentially deadly side effect of Tylenol and similar drugs that contain the chemical paracetamol (acetaminophen). Here are some other dangerous situations that can arise with its use.

Staggered Overdoses of Tylenol

Sometimes people try to take an overdose of Tylenol to commit suicide. A massive dose of the drug can "burn out" the liver, causing a slow and extremely painful death. In the UK, however, at least 168 people over the last 20 years have been treated for "staggered overdoses" of Tylenol, in which enough of the drug was taken to destroy the liver but not as part of a suicide attempt. In these cases, Britons simply tried to take enough Tylenol to get pain relief, but "enough" turned out to be a fatal overdose.

The toxic effects of Tylenol are cumulative. Taking a staggered overdose of the drug is actually more likely to cause severe toxic effects than taking a single, massive overdose of the medication, with more people needing to be put on ventilators or suffering brain damage if it is taken over a period of 24 hours or more.

Acetaminophen-Related Hearing Loss

Another complication of regular use of otherwise non-toxic doses of acetaminophen is hearing loss, especially in men who have not yet reached the age of 60. In a  study of 26,197 men, researchers found that aking just a single dose of any medication in the class of drugs including acetaminophen (that is, who were taking any NSAID drug) twice a week increased the risk of hearing loss by 20%, and taking the medication on a regular basis for more than a year were 33% more likely to develop hearing loss, although the cumulative effects of the drug after one year were questionable. That is, taking acetaminophen pain relievers for more than one year did not make the effect even worse.

Brand-Specific Problems with Paracetamol

Perhaps because it is the world's best-selling brand of paracetamol (acetaminophen), some of the most severe problems with the medication have occurred with the Johnson & Johnson drug Tylenol. In 1982, seven people in the Chicago area died after taking Extra Strength Tylenol that turned out to have been laced with cyanide.

The company pulled all 31 million bottles of Tylenol from store shelves around the country in less than a week, and invented a triple-sealed tamper-proof safety container that allowed Johnson & Johnson to regain its 92% share of the American market. This incident led to the introduction of "child-proof" medication containers for most medications sold in the USA.

In January of 2010, Johnson & Johnson announced a recall of 20 different brands of its products containing Tylenol due to repeated reports of a musty smell that turned out to be due to contamination with a chemical called 2,4,6-tribromoanisole. There are no reports of toxic reactions to 2,4,6-tribromoanisole, but the company recalled its products just to be sure no would be made sick by it.

In April of 2010, Johnson & Johnson recalled 40 of its products after FDA inspectors found a hole in the ceiling covered by duct tape, spilling dust onto machinery below, at one of its manufacturing plants in Pennsylvania. And just a month later, in May of 2010, the FDA announced that certain children's Tylenol products had been contaminated with Burkholderia cepacia, a microorganism that is ordinarily harmless but that can cause serious infections in children who have cystic fibrosis.

Just to be clear, the new FDA warning is not specific to Johnson & Johnson products, and there is every indication that the company would promptly inform its customers if there were defects in its products. However, it is important to be on the lookout for skin reactions when taking any kind of paracetamol product, and it is best to take them only when they are needed, not on a regular basis.