FDA Eyes Acetaminophen & Evalutes Risks Assocaited With Its Use

The Food and Drug Administration is pondering what to do about the wildly popular painkiller in Tylenol, Excedrin, Nyquil, TheraFlu, Vicodin, Percocet and many other commonly used drugs to treat aches and pains and alleviate fevers.

Since all of these medicines have considerable amounts of acetaminophen in them, when you take them collectively, you're getting pretty close to the maximum daily allowance.

After a two day meeting, the FDA panel is calling for sweeping changes to review acetaminophen's safety since years of public education efforts have failed to alleviate the problem.

The FDA now recommends lowering the maximum amount allowed in over-the-counter medications from 4 grams to a lower, undisclosed amount. It also recommends adding a visible warning label on combination drugs that contain acetaminophen, and decreasing the dosage of Extra Strength Tylenol.

ACETAMINOPHEN DANGERS

Acetaminophen is generally very safe and effective, but in excess doses it can cause liver failure. And because acetaminophen is so common -- more than 24 billion doses were sold last year in the United States -- even rare side effects can add up to a lot of problems.

According to the FDA, from 1998 to 2003, acetaminophen was the main cause of acute liver failure in the United States.

According to a June 2006 report published in Pharmacoepidemiology and Drug Safety, between 1990 and 1998, each year there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen overdoses.

A 2007 report from the Centers for Disease Control and Prevention estimates that there are 1,600 cases of acute liver failure each year in the United States, and acetaminophen is the leading and most common cause of liver failure.

The drug is an ingredient in so many products that people often don't realize they are getting multiple doses that could exceed the safe levels. The panel even went as far as to narrowly recommend pulling Vicodin, Percocet and similar products that combine acetaminophen with powerful narcotics from the market altogether.

Now, while the FDA usually follows the advice of its advisory panels, it doesn't have to, and is unsure at this time what action they will take. The FDA panel was split about pulling drugs like Vicodin & Percocet since these drugs are important to so many millions of Americans.

More than 200 million doses of those drugs that combine acetaminophen with narcotics were sold last year in the United States, making them the most common prescribed class of drugs.

The agency could leave drugs like Vicodin and Percocet on the market with stronger, more prominent warning labels. They could also work out a compromise with the companies that make these products where they voluntarily reduce the dosages and take other steps to make them safer.

In the meantime, officials say consumers should pay careful attention to how much acetaminophen they are getting from various products to reduce the chances of suffering complications.

Sources:

Washington Post

WKBW - Buffalo

Examiner.com