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:5/21/2017)... ... May 20, 2017 , ... ... designs created specifically for use in Final Cut Pro X. The business-oriented elements ... productions. Pixel Film Studios’ ProParagraph Corporate will deliver a professional and distinguished look ...
(Date:5/21/2017)... ... ... Florida Pain Relief Group, a division of Physician Partners of America (PPOA), is ... Melbourne, on Monday, May 22. Initially the clinic will be supervised by Physician Partners ... 23 pain management clinics in Florida and the Dallas-Fort Worth, Texas metro area, and ...
(Date:5/21/2017)... Houston,Texas (PRWEB) , ... May 21, 2017 , ... ... but if it's been longer than six months since you've seen a dentist, ... dentist twice per year and getting x-rays once per year. , Dental checkups ...
(Date:5/19/2017)... ... May 19, 2017 , ... ... in an upcoming episode of Innovations with Ed Begley, Jr., airing fourth quarter ... the distributor of a clean, organic dietary supplement made from naturally occurring ingredients. ...
(Date:5/19/2017)... CA (PRWEB) , ... May 19, 2017 , ... The ... consulting to families and entrepreneurs throughout the California Central Valley, is announcing a joint ... of raising community support for a local kid’s camp event. , The Boys and ...
Breaking Medicine News(10 mins):
(Date:5/4/2017)... May 4, 2017  Fortuna Fix Inc. (" Fortuna ... the first to eliminate the need for embryonic and fetal ... treat neurodegenerative diseases. Fortuna announced today ... Michael Fehlings , MD, PhD; Father Kevin FitzGerald ... MPH; and Professor James Giordano , PhD. ...
(Date:5/4/2017)... 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global ... solutions, today announced that it is teaming up with ... Limited to lower diabetes healthcare costs in ... which is available throughout all provinces and territories in ... eligible for additional savings when shopping for Dario supplies ...
(Date:5/3/2017)... 2017  Kalorama Information notes that transplant diagnostics ... year and this is projected to continue to ... (HSCT) or bone marrow transplants require histocompatibility between ... for this task. This according to a new ... The various PCR-based methodologies, Sanger sequencing and NGS ...
Breaking Medicine Technology: