Navigation Links
FDA Adds New Label Warnings to Over-the-Counter Painkillers
Date:4/28/2009

Acetaminophen, NSAIDs can cause liver or stomach illness in certain situations, officials warn,,,,

TUESDAY, April 28 (HealthDay News) -- Many over-the-counter painkillers and fever reducers will have to carry new warnings on the potential danger of liver damage and stomach bleeding, U.S. health officials said Tuesday.

Manufacturers will have to include these warnings on all their over-the-counter products containing acetaminophen (best known as Tylenol), and on all non-steroidal anti-inflammatory drugs (NSAIDs) drugs, according to new rules from the U.S. Food and Drug Administration (FDA).

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

"The regulations affect much of the U.S. population, because over-the-counter pain relievers and fever reducers are some of the most commonly used drugs," Matthew Holman, deputy director of FDA's Division of Nonprescription Regulation Development in the Office of Nonprescription Products, said during a late morning teleconference Tuesday.

The warnings also apply to any over-the-counter drug that contains acetaminophen and NSAIDs mixed with other drugs, Holman said.

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

Products with acetaminophen will carry the warning that it may cause severe liver damage if you take more than the maximum daily dose or if you are also taking other drugs with acetaminophen, or if you have three or more drinks a day while taking the drug.

In addition, the label will also include a warning on using acetaminophen when taking the blood thinner warfarin, Holman said. People taking warfarin should ask their doctor about taking acetaminophen before they start the drug, he said.

"Every over-the-counter product containing a NSAID will have to include a stomach bleeding warning," Holman said.

The warning will highlight risk factors for severe stomach bleeding associated with the product. These include being 60 or older, having stomach ulcers or bleeding problems, taking a blood thinner or steroid, or taking other prescription or nonprescription NSAIDs, Holman said.

Consumers are also warned to ask their doctor about their risk of taking NSAIDs and to stop taking the drug and consult their doctor if there are any signs of stomach bleeding.

These signs include stomach pain that doesn't go away, vomiting blood or blood in the stool, Holman said.

More information

For more on the dangers of NSAIDs and acetaminophen, visit the U.S. Food and Drug Administration.



SOURCE: 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. Prescription labels geared toward pharmacies, not patients
2. FDA: Use the Nutrition Facts Label to Make Healthy Food Choices
3. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
4. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
5. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
6. Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels
7. IOM workshop on less confusing drug labeling, Oct. 12
8. FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma
9. National Patient Advocate Foundation (NPAF) Statement Regarding New FDA Label on Erythropoietin Stimulating Agents (ESAs)
10. National Kidney Foundations 27th Annual Kidney Ball Featuring Entertainment by Patti LaBelle
11. GSK Revises US Labeling for Avandia(R)
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Adds New Label Warnings to Over-the-Counter Painkillers
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... advisory services for healthcare compliance program management, will showcase a range of technology ... Association for Assisted Living (NCAL) Convention and Expo to be held October 14–18, ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... the introduction of an innovative new design of the shoulder pad. The shoulder ... maximum comfort while controlling your pain while using cold therapy. By utilizing ice and ...
(Date:10/12/2017)... ANGELES (PRWEB) , ... October 12, 2017 , ... ... Parsa Mohebi Hair Restoration, has recently contributed a medical article to the newly ... on cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... been named one of Michigan’s 2017 Best and Brightest in Wellness® by Best ... in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... their devotion to personalized service, SMP Pharmacy Solutions announces their ... South Florida Business Journal,s 50 Fastest-Growing Companies, and listed for ... specialty pharmacy has found its niche.  To that end, the ... by SFBJ as the 2017 Power Leader in Health Care. ... award in October, Bardisa said of the three achievements, "It,s ...
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
(Date:9/22/2017)... Sept. 22, 2017 AVACEN Medical (AVACEN) announced ... now successfully helping those with the widespread pain associated ... diagnosed Amanda in Essex, England ... my hair, experiencing no sleep at all, tremendous pain, ... I cannot recommend [the AVACEN 100] enough, how this ...
Breaking Medicine Technology: