Navigation Links
FDA Report Urges Tougher Acetaminophen Warning
Date:5/28/2009

The risk of overdose, and potential liver damage, is still too high, agency says,,

THURSDAY, May 28 (HealthDay News) -- One month after mandating stricter warning labels about the risk of liver damage from the painkiller acetaminophen, U.S. regulators are contemplating even tougher standards.

Advisers to the U.S. Food and Drug Administration will meet late next month to review a new agency report that calls for stronger warnings, better consumer education, and limits on doses for both prescription acetaminophen and over-the-counter acetaminophen, best known as Tylenol.

Part of the problem, according to the FDA report, released Wednesday, is that severe liver damage can result from a lack of consumer awareness that acetaminophen can cause such injury. Also, many people may take more than the recommended dose of over-the-counter pain relievers in the mistaken belief that taking more will be more effective against pain without posing health risks. And consumers may not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose.

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

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using acetaminophen products. It also recommends 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.

The recommendations also include:

  • limiting pediatric liquid formulations to one mid-strength concentration (compared to multiple dose strengths available now);
  • requiring that a measuring device (such as a calibrated cup with dosing increments) 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.

On April 28, the FDA said many over-the-counter painkillers and fever reducers will now have to carry new warnings on the potential danger of liver damage and stomach bleeding.

Manufacturers will have to include these warnings on all their over-the-counter products containing acetaminophen, and on all non-steroidal anti-inflammatory drugs (NSAIDs) drugs, the agency said.

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

The purpose of the new labeling is to raise awareness of potential liver damage from acetaminophen and the potential for stomach bleeding from NSAIDs, the FDA said.

More information

For more on acetaminophen, visit the U.S. National Library of Medicine.



SOURCE: May 28, 2009, news release, U.S. Food and Drug Administration; April 28, 2009, teleconference with Matthew Holman, Ph.D., deputy director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Virginia Tech Report Has National Importance
2. New Study Reports High Injury Rates for Hotel Workers, Even Higher Rates for Women and Nonwhites
3. GAO Report Confirms: Medicare Underpays for Anesthesia Services; Nurse Anesthetists Assure Seniors Access to Safe Anesthesia Care
4. Haemacure Reports Third Quarter 2007 Results
5. Report on patients access to cancer drugs uses flawed methods to reached flawed conclusions
6. Biotech Finishes on a High in August, Burrill Report Says
7. First-Ever List of the 5,000 Fastest-Growing Businesses Reports Total Revenue of $194.5 Billion
8. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best
9. MDS Reports Third Quarter 2007 Results
10. First New York/New Jersey Health Care Report Card Released
11. Authentidate Holding Corp. to Report Fourth Quarter and Fiscal 2007 Year End Results on Thursday, September 13, 2007
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Report Urges Tougher Acetaminophen Warning
(Date:1/13/2017)... ... , ... People who have sensitive teeth are about as common as those ... Sadly, most dental hygiene products in the market contain chemical ingredients that only aggravate ... their daily oral care routine to keep their teeth white and healthy is a ...
(Date:1/13/2017)... ... January 13, 2017 , ... Friday, January 13 at 5 pm, America’s Incredible ... the size of the location to 90,000 square feet. , Included in the expansion ... takes customers on an educational tour of the historic route, with each hole in ...
(Date:1/13/2017)... ... 13, 2017 , ... MyGenetx, a molecular laboratory headquartered in middle Tennessee is ... Taylor Smith, RD, LD, will serve on the 2017 TBCC Board. , ... member and one year as Vice President. She will oversee the newly elected board ...
(Date:1/13/2017)... Boulder, CO (PRWEB) , ... January 13, 2017 , ... ... Congress, a growing alliance of deans of colleges and schools of education across the ... public schools. , In a Declaration of Principles released today, 175 deans sounded the ...
(Date:1/13/2017)... ... ... Hawkins, Pastor and Overseer at The House of Yahweh, has published a new article that ... peace, health and eternal joy. Yisrayl says he has been accused of being the “prophet ... accusations and persecution are nothing new in his world and says it has always been ...
Breaking Medicine News(10 mins):
(Date:1/13/2017)... -- Wichita Laser Clinic at Healthy Life ... Wichita, Kansas featuring the Astanza Revolution ... rejuvenation, getting rid of unwanted tattoos, killing toenail fungus, ... "Since being in the aesthetics industry, I have ... for laser tattoo removal and other popular cosmetic ...
(Date:1/13/2017)... , Jan. 12, 2017   JDRF ... diabetes (T1D) research, is pleased to announce that ... the Centers for Medicare & Medicaid Services (CMS) ... by the FDA for use in making diabetes ... step toward making them eligible for coverage under ...
(Date:1/13/2017)... , Jan. 13, 2017 Over the last 10 years ... developing rapidly (6% – 10% yoy) and are expected to deliver remarkable ... the region, followed by Thailand , the ... , and Singapore .  A member of the G20 ... represents almost 40% of the SEA,s economic output and the largest pharma ...
Breaking Medicine Technology: