An FDA Advisory Committee recently recommended some changes regarding the use and availability of the very common pain medicine acetaminophen. The Advisory Committee was acting on concerns over the incidence of acetaminophen overdosing that have resulted in serious harm to the liver and sometimes death. To address these concerns the Committee made several recommendations including limiting the recommended cumulative daily dose of acetaminophen; limiting the size of the single dose of acetaminophen; and removing prescription medicines that combine acetaminophen with other medicines. The recommendations will result in several products being removed from the market including the 500mg dose of over the counter acetaminophen, like extra strength Tylenol, and pain medicines such as vicodin and percoset and products similar to them.
There is no question that measures should be taken to reduce the incidence of liver damage that results from too much acetaminophen. The main contributor to the problem is that: 1) consumers do not know the risks and 2) consumers do not know how much acetaminophen they are ingesting. These factors are best addressed by education and labeling, not by taking off the market these medicines that are safe and effective when used appropriately.
Acetaminophen is a very commonly used pain reliever that is easily purchased over the counter. Many of us tend to think that “over the counter” means “safe.” That is simply and radically NOT TRUE. Any medicine taken in quantities more that recommended is dangerous. For acetaminophen you add the problem that many products that contain acetaminophen do not mention it on the label. Often the label mentions APAP which is shorthand for acetaminophen…..a designation not known by most people. Why not just do a very good public health education campaign about the risks of overuse of acetaminophen and why not just correct the labeling?
Removing these commonly used medicines is not the answer. Lower dosage acetaminophen will reduce the effectiveness of the over the counter products leaving many people in pain or driving them to other pain relievers which, for them, may have other risks. Removing the prescription combination medicines will result in a stampede to doctors to find safe and effective alternatives which, with the current arsenal of medicines, may be very difficult.
YOU CAN DO SOMETHING ABOUT THIS! The FDA has asked for the public to comment on these recommendations. YOUR VOICES ARE IMPORTANT! To let the FDA know what you think, submit your comments by clicking here.
The deadline for writing to the FDA is September 30th, so TAKE ACTION NOW!.
Published On: September 11, 2009