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:12/2/2016)... Milford, NJ (PRWEB) , ... December 02, 2016 , ... ... Nothing Water has some unique properties including its unmatched natural purity of just 6 ... as clean and crisp. , Nothing Water has been available in several ShopRite and ...
(Date:12/2/2016)... ... December 02, 2016 , ... Clarify Health ... has raised $6.0 million in an initial round of funding. The round was ... and their caregivers can receive far better care through the application of the ...
(Date:12/2/2016)... ... December 02, 2016 , ... ‘Tis the season for giving! Today, 20 ... the National Family Partnership and the Drug Enforcement Administration as part of the National ... the 10 winning schools who decorated their campuses with this year’s Red Ribbon Week ...
(Date:11/30/2016)... PALMYRA, Wisconsin (PRWEB) , ... November 30, 2016 ... ... inclusion in the 2016 Deloitte Wisconsin 75, an annual ranking and recognition of ... consecutive year on the list, having ranked from 2008-2016. In addition, Standard Process ...
(Date:11/30/2016)... ... November 30, 2016 , ... ... and stylish design wanted by today’s consumers at an affordable price, is now ... says the new watch is “a game changer” when it comes to the ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... in the ECG Cables And ECG Leadwires Market owing to ... devices. On the other hand, the Asia-Pacific ... rate during the forecast period. The market players ... plc ( Ireland ), Koninklijke Philips N.V. ( ... ( China ), held major share of the ...
(Date:12/2/2016)... PUNE, India , December 2, 2016 /PRNewswire/ ... research report "In Vitro Diagnostics/IVD Market by Product ... Diagnostics, Hematology), Application (Diabetes, Oncology, Cardiology, Nephrology, Infectious ... the global market is valued at USD 60.22 ... grow at a CAGR of 5.5% during the ...
(Date:12/2/2016)... On Thursday, December 1st 2016, ... research, development and innovation in the biopharmaceutical industry at ... in the presence of Sergey Tsyb, Vice Minister of ... , Natalia Sanina, First Vice Chairman of the ... of Roszdravnadzor, National Service of Control in Healthcare, Sergey ...
Breaking Medicine Technology: