I utilize this column to moderate news media overreaction to drug scares, but I also monitor under-reactions. This is a case of under-reaction. Acetaminophen is a feel-good drug that is just too easy to overuse. The media coverage of FDA’s courageous stance isn’t sufficient. Tylenol, etc., is a great drug but it is also a silent killer. We need to keep track of how much we take before we become yet another statistic.

Acetaminophen, also known as APAP, the active chemical in Tylenol, is a wonder drug that eases the pain of patients with disabling arthritis and lowers the temperature of many with flu or colds.  But acetaminophen is only safe up to a point, and because it is ubiquitous, it is easy to lose track of how much you’ve had.  You may limit the amount of Tylenol you take, but then lose track of the amount of cold medicines or pain pills you are taking. Anything over 4 grams a day is very toxic to the liver, but less acetaminophen can have the same affect if you mix it with alcohol or have underlying liver disease.

The FDA has been very aware of this problem and in 2011 warned the drug companies who made combination pain pills (Vicodin, Percocet, etc.), to limit the amount of acetaminophen in a pain pill to a maximum of 325 mg. This makes a lot of sense, but only half of drug companies making these products complied.

So now, the FDA is getting tougher. With 150 Americans dying every year and 22,000 acetaminophen overdoses, they have every right to clamp down on prescriptions and demand now that their limitations be obeyed. Drugs with higher doses of acetaminophen will be removed from the market. Warnings will be put on the labels. Over-the-counter preparations will be next.

Considering that acetaminophen overdose is a leading cause of liver failure and liver transplant around the world, I cannot call this an over-reaction. Yes there is an antidote (activated charcoal followed by N-acetylcysteine NAC). But how often is this antidote given in time?

From the February 01, 2014 Issue of MM+M - Medical Marketing and Media