Personal Injury Law

Tylenol Smaller Doses May Prevent Liver Damage

By Jane Akre

An expert panel convened to advise the U.S. Food and Drug Administration (FDA) on drugs, voted today Tylenol should be given in smaller doses and the Extra Strength Tylenol should be sold by prescription only to reduce the dangers of serious liver injury.

Johnson & Johnson's Tylenol, or acetaminophen, is the most commonly used painkiller in the country, recommended as the first line of defense for bone and muscle pain.

The present dosage recommended is two 500-mg tablets every four to six hours for adults with a maximum daily recommended dosage not to exceed 4,000 mg for adults.  The outside advisors to the FDA voted 21-to-16 that the 4,000 mg daily ceiling be lowered. They also voted the 500 mg. Extra Strength dose be available by prescription. 

Bloomberg reports that the 500-mg tablets represent more than 90 percent of U.S. sales. 

They also voted that the single adult dose be lowered to 650 mg. which represents two regular strength tablets. 

Acetaminophen has been linked to 56,000 emergency room visits, as well as 26,000 hospitalizations and 458 deaths in the 1990s, according to the FDA.

In addition, a 2007 CDC study found that 1,600 acute liver failures were likely caused by acetaminophen.

The painkiller combined with decongestants accounts for about half of all sales. Those drugs include Tylenol Cold, Midol, and Excedrin. 

It is also possible that Tylenol combined with other drugs in OTC formulations could be pulled including Nyquil, Pamprin, and Allerest.  

Acetaminophen is one of the most commonly used drugs in the U.S. for treating pain and fever with Americans purchasing more than 28 billion doses.  Tylenol was first introduced for children in an elixir form in the mid 1950s, according to the J & J Web site. 

The FDA reported in May that the 4 grams per day maximum recommended dose of acetaminophen could cause serious liver injury and death. 

The FDA does not have to follow the recommendations of the expert panel, but usually does.

Other acetaminophen prescription products include Vicodin, and Percocet. Other painkillers available to consumers are aspirin, ibuprofen, and naproxen, but ibuprofen has its own problems with gastrointestinal bleeding.  #

Full post as published by InjuryBoard on June 30, 2009 (boomark / email).