The FDA Investigates Acetaminophen Safety

A government advisory panel organized by the FDA began voting today on various recommendations that would either cut down dosages of acetaminophen or completely pull combination drugs that contain acetaminophen off the shelves – immensely popular over-the-counter drugs like Tylenol and NyQuil.

So once again we are given an opportunity to evaluate the Food and Drug Administration and the relative safety this government organization provides for us and our families. Here’s an interesting fact to start the discussion…

“Although it is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.”
Source: http://www.cnn.com/2009/HEALTH/06/30/acetaminophen.fda.hearing
 

To put that in perspective, the FDA recently came down hard on the makers of Zicam because about 130 people reported losing their sense of smell over a 10+ year period. To my recollection, nobody died from taking Zicam, yet they were dragged through the media just a few weeks ago.
 

According to the FDA itself, over 400 deaths have been linked to one of the most popular drugs of all time, acetaminophen… an FDA-approved drug.
 

The panel organized by the FDA will vote on nine options and rank their recommendations in order of importance for both OTC and prescription medications. The FDA will make their final recommendation from these votes.
 

More from the CNN report:
 

The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated that acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year.”
 

The Consumer Healthcare Products Association, an over-the-counter trade organization, said in a briefing memo that combinations of over-the-counter drugs make up only a small portion of acetaminophen overdoses.
 

"Serious liver injuries are rarely due to OTC combination products (less than 10 percent of all cases), with many more cases attributable to Rx combination products. CHPA strongly opposes the elimination of OTC acetaminophen containing combination products," the organization wrote.

10% of 1600 = 160 “serious liver injuries” are apparently due to OTC combination drugs containing acetaminophen according to that statement. Four hundred and fifty-eight deaths (458) in the 1990s.
 

Liver failure…or temporarily losing your sense of smell…what should be of greatest concern to us?

 

Posted by Ben