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Tuesday, October 13, 2009

The Problem With Tylenol

On Thursday, May 28 (HealthyDay News) – one month after mandating stricter warning labels about the risk of liver damage from the painkiller acetaminophen or Tylenol, U.S. Regulators are contemplating even tougher standards.

Advisors to the U.S. Food and Drug Administration met in late April to review a new agency report that calls for stronger warnings, better consumer education, and limits on doses for both prescription Tylenol, and over-the-counter Tylenol.

According to the FDA report, released on Wednesday, September 30, part of the problem is that severe liver damage can result from a lack of consumer awareness that Tylenol can really cause this injury. However, many people may take more then is recommended of the over-the-counter pain relievers believing that more is better and that it won't hurt them. Most consumers seem to forget that Tylenol is in many cold, headache, fever remedies, making it possible to exceed the recommended Tylenol dosage.

For more than five years of FDA-sponsored consumer education campaigns, the report said, “recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur.”

The report also recommended limiting the maximum adult daily doses to no more then 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using Tylenol products. Limiting the tablet strength for immediate-release formulations to a maximum of 325 milligrams, and the single adult dose to a maximum of 650 milligrams, was another recommendation of the report.

Other recommendations from the report were;

limiting pediatric liquid formulations to one mid-strength concentration (compared to multiple dose strengths available now);

requiring that a measuring device (such as using a calibrated cup with dosing increments much like cold and cough remedies have now) to be included in each package;

including dosing instructions for children under 2 years of age if accurate dosing instructions can be determined and adequate efficacy data exist to support dosing.

Then on April 28th, the FDA came out with the statement that many over-the-counter painkillers and fever reducers will now have to carry new warnings on the possible dangers of liver damage and stomach bleeding.

The manufacturers will also have to include these warnings on all their over-the-counter products containing Tylenol, and on all non-steroidal anti-inflammatory drugs or NSAIDs, the agency said.

NASIDs include popular medicines such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve) and Excedrin.

The purpose of the new labeling is to help consumers become more aware of the potential liver damage from Tylenol and the potential for stomach bleeding from NSAIDs, the FDA said.

For More Information

Visit the U.S. National Library of Medicine to learn more about acetaminophen.


U.S. News, October 1, 2009: FDA Report Urges Tougher Acetaminophen Warning The risk of overdose, and potential liver damage, is still too high, agency says, by Steven Reinberg a reporter for HealthDay.
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