Navigation Links
FDA Limits Acetaminophen in Prescription Combination Products; Requires Liver Toxicity Warnings
Date:1/13/2011

SILVER SPRING, Md., Jan. 13, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen, also called APAP, is a drug that relieves pain and fever. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. Patients and health care professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider," said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

Acetaminophen also is widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients.  The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency's strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

An FDA advisory committee discussed the issue at a meeting in June, 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

For more information and a list of affected products, please visit: www.fda.gov/acetaminophen.

Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Iron Andy Holder - Ironman Competitor with Diabetes Encourages Others to Live Without Limits
2. Ironman Competitor with Diabetes Encourages Others to Live Without Limits; Inspiring Triathlete Participates in Health Fair at The Medicine Stop 5525 South Pulaski Road, Chicago Thursday, August 26, 2010, 1:00 pm - 4:00 pm
3. Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
4. Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen
5. Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead of Schedule
6. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
7. CVS Caremark Study Finds Medication Adherence Leads to Lower Health Care Costs, Even After Accounting for Increased Prescription Drug Spending
8. CutisPharma Launches New Prescription Mouthwash Kits Expanding Product Line
9. 36 Million Americans have Bought Medications Online Without a Doctors Prescription
10. Use of Non-Traditional Providers in the Phoenix Market Will Improve Diabetes Prescription Drug Adherence
11. Auditor General Jack Wagner Says State Could Save Millions by Consolidating Prescription Drug Purchases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/7/2017)... Aug. 7, 2017 Insightin Health, provider ... retention, and engagement, announced the selection of ... Product Development, effective as of February 2017. In this ... implementation strategy for our clients. Wood brings with ... consulting and business analytics within the healthcare industry. ...
(Date:8/7/2017)... DUBLIN , Aug. 7, 2017  Endo International ... has reached agreements to resolve virtually all known U.S. ... in discussions to resolve the known remaining U.S. claims ... installment payments beginning in the fourth quarter of 2017 ... part of its second quarter 2017 results, the Company ...
(Date:8/2/2017)... , Aug. 2, 2017 Fenita ... Who as a Pinnacle Lifetime Professional in the ... Account Manager at Turing Pharmaceuticals, AG. Her skills ... and relationship building.                ... than 25 years of experience as a highly ...
Breaking Medicine Technology:
(Date:8/23/2017)... ... August 23, 2017 , ... Arizona ... hospitals nationally that earned the designation of High Performing Hospitals by U.S. News ... performing indicates a hospital was significantly better than the national average in a ...
(Date:8/23/2017)... ... August 23, 2017 , ... ... Golden Bridge Awards® - for Risk Management Solution Innovations and Security Solution for ... online platform released in 2017 and its DHS SAFETY Act-designated enterprise security assessment ...
(Date:8/22/2017)... ... August 22, 2017 , ... The ... health is as simple as eating healthy foods. But this well-known piece of ... making insulin, or breaking apart carbohydrates—depends not only on properties of the food ...
(Date:8/22/2017)... ... August 22, 2017 , ... Nurses at Apple Rehab Watch ... Cove, recently received training and certification in Closed Pulse Irrigation™ (CPI) for ... five-star rating from the Centers for Medicare and Medicaid Services, to have a CPI ...
(Date:8/22/2017)... ... August 22, 2017 , ... “Covert ... the creation of published author, Julianne Hale, a consultant for the Intelligence Community. ... counter-terrorism expert focusing on the Near East region. Julianne has written hundreds ...
Breaking Medicine News(10 mins):