Navigation Links
FDA Advisers Urge Smaller Doses of Acetaminophen
Date:6/30/2009

The concern is that the drug can cause liver damage, even death, if used improperly

TUESDAY, June 30 (HealthDay News) -- U.S. health advisers recommended Tuesday to lower the maximum dose of over-the-counter acetaminophen -- the key ingredient in Tylenol, Excedrin and many other pain-killing medications.

The advisers' vote followed the release of a U.S. Food and Drug Administration report last month. It found that severe liver damage and even death can result from a lack of consumer awareness that acetaminophen -- which is easier on the stomach than painkillers such as aspirin and ibuprofen -- can cause such injury.

Also, many people may take more than the recommended dose of acetaminophen-based, over-the-counter pain relievers in the mistaken belief that taking more will be more effective against pain without posing health risks. And consumers may not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.

The FDA advisory panel voted 21-16 Tuesday to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams - equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.

The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.

The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity [liver damage] continue to occur," last month's report said.

Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday's votes were very important to "people with arthritis because acetaminophen is a very commonly used medication to control pain."

"Lowering the maximum dose, providing that kind of guidance to patients, if it increases safety, would be something the arthritis community would support," he said. "Every person who takes this drug sees it as valuable, but they want clear guidance so they won't be harmed by the drug."

Dr. Lewis W. Teperman, director of transplant surgery and vice chairman of surgery at New York University School of Medicine, said he supported the panel's decision to recommend lowering doses of acetaminophen.

"It's not that the doses can get you in trouble, but the very young and the very old can get into trouble easily," he said. Also if you are sick there is the danger of taking cold remedies that contain acetaminophen plus taking pure acetaminophen drugs as well, he noted.

But Klipper said the vote to make the 1,000-milligram dose of acetaminophen available only by prescription would overburden the health-care system. "Given the massive number of people who rely on this drug for pain control, making the maximum dose requiring a prescription, I think is going to place undo burden on the health-care system," he said.

On the other hand, Teperman supported the 1,000-milligram recommendation.

"The 1,000 milligram pill should never be at the patient's discretion. It should only be prescribed by a physician," Teperman said. "If you took an entire bottle of Tylenol Extra Strength, three days later you would be in a coma and needing a liver transplant."

Klippel said he'd like to see more education for consumers, alerting them to the potential dangers of acetaminophen. "Give consumers the benefit of the doubt," he said. "Consumers want to do the right thing, and if dosage in acetaminophen is important the consumer will follow."

More information

For more on acetaminophen, visit the U.S. National Library of Medicine.



SOURCES: John H. Klippel, M.D., CEO, Arthritis Foundation; Lewis W. Teperman, M.D., director of transplant surgery, vice chairman of surgery, New York University School of Medicine, New York City; May 28, 2009, news release, U.S. Food and Drug Administration; Associated Press


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Advisers Urge Ban on Cold Medicines for Young Children
2. U.S. Advisers OK Nasal Spray Flu Vaccine for Young Children
3. FDA Advisers Reject Over-the-Counter Statin
4. FDA Advisers Dont Back Epilepsy Drug Warnings
5. FDA Advisers Dont Back Black Box Warning for Epilepsy Drugs
6. Musculoskeletal Clinical Regulatory Advisers, LLC Announces Signing of its 100th Client
7. FDA Advisers Recommend Smaller Doses of Acetaminophen
8. Smaller breast reduction surgeries provide health benefits and should be reimbursed
9. Nordic Naturals Introduces Ultimate Omega 500 - Their Best Selling Formula Now Available in a Smaller Size Soft Gel!
10. Smaller babies more prone to depression, anxiety later on
11. Pancreatic cancer: The smaller the tumor, the better your chances, study shows
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advisers Urge Smaller Doses of Acetaminophen
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The ... the most popular and least understood books in the Holy Scriptures, Revelation. The Book ... have baffled scholars for centuries. Many have tossed it off as mere rubbish, but ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the Mission ... lost souls in the Philippines. “The Journey: From the Mountains to the Mission Field” ... the Bible. She has taught all ages and currently teaches a class of ladies ...
(Date:10/12/2017)... ... 12, 2017 , ... CitiDent and San Francisco dentists, Dr. ... Oventus O2Vent technology. As many as 18 million Americans are estimated to suffer ... Oral appliances can offer significant relief to about 75 percent of people with ...
(Date:10/12/2017)... , ... October 12, 2017 , ... IsoComforter, Inc. ( ... announced today the introduction of an innovative new design of the shoulder pad. ... you get maximum comfort while controlling your pain while using cold therapy. By utilizing ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... Sept. 22, 2017  As the latest Obamacare repeal ... Bill Cassidy (R-LA) and Lindsey Graham ... the medical device industry is in an odd place. ... the 2.3% excise tax on medical device sales passed ... want covered patients, increased visits and hospital customers with ...
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
(Date:9/12/2017)... LAKES, N.J. , Sept. 12, 2017  Consumer reviews on ... Embrace Hearing as the number one company for hearing aids, ... ReSound™ and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides ...
Breaking Medicine Technology: