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:10/13/2017)... ... October 13, 2017 , ... As health professionals work to ... “patient engagement.” The patient is doing more than filling out a survey; in many ... is an increasing emphasis in health care and research on the importance of active ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, ... guideline updates for the primary prevention of cardiovascular diseases during the 15th ...
(Date:10/13/2017)... ... 2017 , ... Ellevate Network, the leading network for professional women, brought together ... equality at their inaugural Summit in New York City in June. The event was ... of over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... , ... October 13, 2017 , ... “The Journey: From ... every danger possible to save lost souls in the Philippines. “The Journey: From the ... is a dedicated teacher of the Bible. She has taught all ages and currently ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare ... CPR training aide "cprCUBE" on Kickstarter. The device will ... during cardiac arrests with better efficiency compared to the ... offers real-time feedback on efficacy of the compression for ... campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... -- AllianceRx Walgreens Prime, the combined central specialty pharmacy and ... manager Prime Therapeutics LLC (Prime), today officially began the ... of new signage at its headquarters in ... few other company-owned facilities across the country. This also ... whom will begin to see the AllianceRx Walgreens Prime ...
(Date:9/27/2017)... -- Commended for their devotion to personalized service, SMP Pharmacy Solutions ... in the South Florida Business Journal,s 50 Fastest-Growing Companies, and ... the national specialty pharmacy has found its niche.  To that ... be honored by SFBJ as the 2017 Power Leader in ... receive his award in October, Bardisa said of the three ...
Breaking Medicine Technology: