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
'/>"/>

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

Page: 1 2

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:1/23/2015)... , Jan. 23, 2015  Northwest Biotherapeutics, Inc. (NASDAQ: ... personalized immune therapies for operable and inoperable solid tumor cancers, ... at the 7 th Annual Phacilitate Immunotherapy Forum in ... presentation at Phacilitate will take place on January 26 at ...
(Date:1/23/2015)... , Jan. 23, 2015 More than a third ... quarter of those with private insurance, filled a prescription for ... a report in this week,s Morbidity and Mortality Weekly Report ... care providers to treat moderate to severe pain.  They are ...
(Date:1/23/2015)... YORK , Jan. 23, 2015 /PRNewswire/-- Harwood Feffer LLP ... board of directors of Advaxis, Inc. ("Advaxis" or the ... board has breached its fiduciary duties to shareholders. ... on an investing website reporting that Advaxis had misrepresented ...
Breaking Medicine Technology:NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 2NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 3Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2
... 7, 2007 - REGENERX,BIOPHARMACEUTICALS' (AMEX: RGN), www.regenerx.com ... the 2007 Association for Research in,Vision and ... May 9th to discuss TB4's ability to ... process closely,associated with inflammation that, if not ...
... TSX-V: PGA, VANCOUVER, May 07, 2007 /PRNewswire-FirstCall/ - ... results from its Phase I/II study of PAC-113, ... and active,in the treatment of oral Candida infection ... of care. Based on these results,the Company plans ...
Cached Medicine Technology:Dr. Gabriel Sosne to Present New TB4 Data at 2007 ARVO Meeting 2Dr. Gabriel Sosne to Present New TB4 Data at 2007 ARVO Meeting 3Pacgen Announces Positive Results from Phase I/II Trial of Novel,Antifungal Drug 2Pacgen Announces Positive Results from Phase I/II Trial of Novel,Antifungal Drug 3Pacgen Announces Positive Results from Phase I/II Trial of Novel,Antifungal Drug 4Pacgen Announces Positive Results from Phase I/II Trial of Novel,Antifungal Drug 5
(Date:1/23/2015)... January 23, 2015 Hastings and Hastings, a ... reports a record number of legal representation client review requests ... has been a steady rise in the number of slip ... at home throughout the Valley. With that said, a large ... reviewed by an experienced law firm. Hastings and Hastings is ...
(Date:1/22/2015)... (PRWEB) January 23, 2015 LunaDress, with its ... the fashion industry. Now, the business is showing its latest ... women’s dresses. , According to the company’s CEO, all the ... now offered with big discounts, up to 80% off. All ...
(Date:1/22/2015)... January 22, 2015 Padre Murphy's and Owner ... of Pro Player Health Alliance (PPHA). The PPHA's ... in getting everyone, including NFL greats, treated for obstructive sleep ... leading groups supporting the cause in the valley. The most ...
(Date:1/22/2015)... Blue Cross and Blue Shield of Minnesota ... it means to “Live Fearless.” , The “Faces ... their stories about how they or someone they know has ... living in the moment. By telling these types of stories ...
(Date:1/22/2015)... A new white paper by The Beryl ... the long-term care environment as well as provides recommendations ... paper, “The Power of Person-Centeredness in Long-Term Care: A ... the patient, resident and family experience in long-term care ...
Breaking Medicine News(10 mins):Health News:Hastings and Hastings Reports a Record Number of Client Review Requests for Slip and Fall Accidents in 2014 2Health News:LunaDress Shows The Latest Styles Of Wedding Dresses In 2015 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 3Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3
... measurement devices implanted inside a living body. The object ... the presence of the implant. An example of a ... long since become standard treatment for heart patients. Researcher ... (TUT) believes that the next tech-savvy generation represents a ...
... conservative treatment may be warranted, study finds , MONDAY, May ... to extend the life of elderly people with kidney cancer ... it suggests, people with such cancer should undergo more conservative ... , Kidney cancer cases have increased over the past 10 ...
... ... 10 SSDI recipients would have found it useful to know representation options before filing ... ... Security disability benefits on their own, only to have their application denied, according to ...
... ... soulful jazz & R&B vocal stylings through his jazz community. , , ... Oakland, CA (PRWEB) May 10, 2010 -- Nicolas ... of Bobby McFerrin,s renowned vocal ensemble " Voicestra" and it,s offshoot, the vocal sextet ...
... ... at Increased Risk for Eye Disease , ... San Francisco, CA (Vocus) May 10, 2010 -- EyeCare America ... this national campaign, in partnership with the National Eye Institute. New research from the Los ...
... The ... state and local reporters assistance in analyzing how the new health reform law will ... great clearinghouse of information about health care issues for children and families." , ... Washington, D.C. (PRWEB) May ...
Cached Medicine News:Health News:Vital functions monitored with wearable and implantable devices 2Health News:Vital functions monitored with wearable and implantable devices 3Health News:Getting Help with Initial Social Security Disability Application Can Speed Access to Benefits 2Health News:Getting Help with Initial Social Security Disability Application Can Speed Access to Benefits 3Health News:Getting Help with Initial Social Security Disability Application Can Speed Access to Benefits 4Health News:Vocalist Nicolas Bearde Unveils his Music Catalogue Through The Jazz Network Worldwide 2Health News:Vocalist Nicolas Bearde Unveils his Music Catalogue Through The Jazz Network Worldwide 3Health News:EyeCare America Partners with the National Eye Institute during May's Healthy Vision Month 2Health News:EyeCare America Partners with the National Eye Institute during May's Healthy Vision Month 3Health News:Georgetown Research Center Helps Reporters Decipher Health Reform Law & Impact on State Residents 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: