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:2/12/2016)... ... February 12, 2016 , ... A lot has been reported about the fitness ... access to health and wellness resources most Americans could ever dream of having at ... a schedule as frenetic as the U.S. President. , In honor of President’s ...
(Date:2/12/2016)... ... ... The Central Coast Autism Spectrum Center (CCASC) invites teens ages 11-18 to its annual Winter ... teens with and without special needs to gather in a safe and supportive environment. Volunteers ... will take place on Saturday, Feb. 13 from 7 to 9:30 p.m. at Elks Lodge, ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Yisrayl Hawkins, Pastor ... article this week that uncovers what he says are the real facts surrounding all ... the Bible from parents and Sunday school teachers, and Yisrayl says there is more ...
(Date:2/12/2016)... ... February 12, 2016 , ... Planet Future ... new cartoon style themes are great for showcasing pictures, videos as well as text ... titles like introductions, lower thirds, transitions and a beautiful frame overlay. Pixel Film Studios ...
(Date:2/12/2016)... ... ... Dignity Health named Dr. Scott Bingham the Facility Medical Director of the ... licensed under Dignity Health Arizona General Hospital , which opened last year in ... our new freestanding emergency room delivers the highest quality care to Mesa and the ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016  Kindred ... focused on saving and improving the lives of pets, ... Technical Section of the New Animal Drug Application (NADA) ... the pivotal field study (KB0120) of Zimeta for the ... by the Company. --> ...
(Date:2/11/2016)... N.Y. , Feb. 11, 2016  Governor Andrew ... that will create 1,400 jobs throughout Western ... a partnership with the SUNY Polytechnic Institute, includes a ... Conventus Building in Buffalo , as ... foot manufacturing facility in Dunkirk . ...
(Date:2/11/2016)... 11, 2016 Potrero Medical, Inc., the developer of ... the appointment of George M. Rapier, III , MD, ... TX , WellMed is one of the nation,s largest ... HMO members in Texas and ... of his own internal medicine practice, he has been instrumental ...
Breaking Medicine Technology: