You’ve probably heard or read recently that acetaminophen – the generic name for the pain reliever, Tylenol – is in the news a lot lately. A Food and Drug Administration (FDA) expert advisory panel recently came out with recommendations for the FDA to put restrictions on the use of this very commonly used drug.

Why now? Because after reviewing studies done between 1990 and 1998, this panel of experts came to the conclusion that acetaminophen is not as safe as previously thought.  Due to overdose of this medication, there were 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths ANNUALLY over the time period of the reviewed studies. The most common problems seen were that of liver damage, liver failure and even death.

The interesting aspect of these findings is that not only did massive doses above the recommended dosages lead to illness, but even normally recommended doses could do the same, especially in people who already have liver disease. From this data, the expert panel came to the conclusion that restricting acetaminophen, and lowering the maximum doses advised, would protect people from the potential toxicity of this drug.

Since acetaminophen is so readily available without a prescription ( over-the-counter; OTC), and is so widely recommended for pain relief  by healthcare professionals, it almost goes without saying that a majority of people use this drug routinely. In addition, it is known that many people do not pay attention to the recommended doses listed in the package insert or on the bottle, and routinely exceed the highest recommended dose per 24 hours.  Besides being the main ingredient in Tylenol, acetaminophen can also be found in Excedrin, aspirin-free Anacin, and wide variety of OTC cold medications.

In addition to the OTC medications, acetaminophen is found in many prescription combination pain relievers, such as Vicodin, Darvocet, and Percocet, to name a few. The amount of acetaminophen in most of these prescription combination drugs often exceeds the maximum dosage recommended  for a 24 hour period.

It will probably take the FDA many months to put restrictions on the amount of acetaminophen that can be found in OTC medications as well as prescription pain relievers. So, what should you do until then? Look at the label for the amount of acetaminophen contained in both the OTC medications you buy, as well as the prescription pain-relievers prescribed by your clinician. The FDA recommends that the highest one-time dose (two tablets) of acetaminophen for adults should be no more than  650 mg. That means that the individual tablet should contain no more than 325 mg of acetaminophen. FYI – currently two tablets of Tylenol contain 1000 mg of acetaminophen.

In addition, the currently recommended maximum recommended dosage for an adult for 24 hours is 4000 mg (4 grams). The FDA thinks that this amount should be lowered as well, and definitely should not be exceeded.

Let’s do some quick math here. Say you have a headache or your old tennis elbow pain has flared up. Although people are supposed to take only 2 tablets every 6 hours (which would reach 4000mg per day), many of my patients have told me that they take this amount every 3-4 hours; that comes to 6000 mg per day IF they only take 2 tablets of Tylenol, and some people even take 3. That’s obviously way above the highest dose recommended per day, and definitely can lead to toxicity from this drug. Also, be aware that your health care practitioner may change your longterm prescription pain reliever by ordering one in which the amount of acetaminophen is lower. The narcotic portion of your combination medication may well stay the same.

Until the FDA officially restricts acetaminophen in OTC and prescription medications, here’s what you should do: 1) Remember the maximum safe dosage per day of acetaminophen (4000mg;4 grams); 2) Remember the maximum safe dosage for a one time dose of acetaminophen (625mg); 3) Read all labels of OTC medications you buy to see how much acetaminophen is contained; 4) Discuss with your clinician if you should change your prescription medication for pain relief if acetaminophen is in it.