Navigation Links
FDA Lowers Amount of Acetaminophen Allowed in Prescription Painkillers
Date:1/14/2011

By Amanda Gardner
HealthDay Reporter

THURSDAY, Jan. 13 (HealthDay News) -- U.S. health officials announced Thursday that they will lower the maximum amount of the pain reliever acetaminophen allowed in prescription opioid products such as Vicodin and Percocet because of reports of severe liver damage.

Over a period of three years, the upper threshold of acetaminophen in prescription drugs containing opioids such as codeine will be set at 325 milligrams per dose. Right now, such products can contain up to 750 milligrams of acetaminophen, Dr. Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration, said during a Thursday news conference.

The FDA will also be mandating that such prescription combination products include "black box" warnings on their labels alerting users to the potential for liver damage.

"We're taking a major step in the agency's overall strategy to reduce the risk of intentional and unintentional liver damage that can occur if a patient takes too much of the common painkiller acetaminophen," Kweder said. "[But] let me also be clear that, when taken as directed, acetaminophen is a very safe product. Our goal is to make it even safer."

Patients already taking such products should not stop taking them without consulting a health-care provider, she emphasized. "There is no immediate threat to patients, even at the higher dose," she said.

The new actions do not affect over-the-counter (OTC) products containing acetaminophen such as Tylenol and Nyquil, although Kweder said the agency is considering taking action in that area as well.

Right now, OTC products can contain up to 500 milligrams of the ingredient with a limit of four doses per 24-hour period. These products already carry warnings of possible liver damage on their labels.

Overdoses from these prescription combination products account for nearly half of all cases of acetaminophen-related liver damage in the United States, according to Dr. Gerald Dal Pan, director of CDER's Office of Surveillance and Epidemiology. "Many of [the cases of liver damage] result in liver failure or death," he added.

Many of the 800 acetaminophen-related cases of liver injury each year in the United States occur because a person is taking two acetaminophen products at one time, often for two different conditions such as back pain and migraine, and this can exceed the recommended daily limit, he said. Combining acetaminophen with alcohol can also be dangerous.

Although over-the-counter medications containing acetaminophen clearly state the ingredients, prescription products are less clear. Many patients may not know that the drug they're taking contains acetaminophen and often they aren't warned to avoid other acetaminophen-containing products.

Some 200 million prescriptions were dispensed for acetaminophen/opioid prescription products in 2008, said Kweder, who added that lower-dose versions of the drugs "won't be any less effective."

These latest actions follow the advice of an FDA expert advisory committee issued in June of 2009.

The FDA is encouraging patients to:

  • Carefully read all labels for prescription and OTC medications and ask if their prescription medicine contains acetaminophen.
  • Don't take more than one acetaminophen-containing product at one time and that includes OTC medications.
  • Don't take more than the maximum daily amount of 4 grams, or 4,000 milligrams, of acetaminophen a day.
  • Avoid drinking alcohol while taking acetaminophen.
  • Stop taking acetaminophen and seek medical help immediately if you experience allergic reactions such as rash, itching, swelling of the face and/or difficulty breathing.
  • Seek medical help right away if you think you have taken more than the directed dosage of acetaminophen.

More information

For more on the affected acetaminophen-containing products, visit the FDA.

SOURCES: Jan. 13, 2011 teleconference with: Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Gerald Dal Pan, M.D, director, Office of Surveillance and Epidemiology, CDER, FDA


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Paxil Blocks Tamoxifen, Lowers Survival Odds Against Breast Cancer
2. IRS Whistleblower Office Makes Good Again: Kenney & McCafferty Whistleblowers Receive Full Reward
3. Exposure to nitrogen dioxide lowers in vitro fertilization success
4. Forget the Flowers for Mother's Day This Year -- Get Her a Massage Instead
5. Musts For Mom: Breakfast In Bed And Beautiful Flowers
6. For Drug Company Whistleblowers, Hardship Often Follows
7. Alcohol consumption lowers risk of developing several arthritic conditions
8. Moderate Coffee, Tea Drinking Lowers Heart Disease Risk
9. Why more education lowers dementia risk
10. New Software for Defibrillators Lowers Risk of Unnecessary Shocks
11. Daily Pill Lowers Odds for Infection With HIV
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Lowers Amount of Acetaminophen Allowed in Prescription Painkillers
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance ... management, will showcase a range of technology and learning solutions at the 68th ... and Expo to be held October 14–18, 2017 at the Mandalay Bay Resort ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris F. ... AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking place ... the field of medical informatics, this prestigious award is presented to an individual whose ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... Leading pediatric ... peers in Washington, D.C., for the 49th Congress of the International Society of ... Vice President of the Center for Cancer and Blood Disorders at Children’s ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... latest in wound care advancements to physician colleagues, skilled nursing facility medical directors ... "Navigating the Treacherous Waters of Wound Care." , "At many of these conferences ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. ... big data solutions, today announced that its MyDario product is expected to ... TV listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, ... ...
(Date:9/22/2017)... 2017 AVACEN Medical (AVACEN) announced that its ... helping those with the widespread pain associated with fibromyalgia ... in Essex, England commented, "I ... experiencing no sleep at all, tremendous pain, with every ... recommend [the AVACEN 100] enough, how this has and ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has been ... Atlanta Football Host Committee (AFHC) for the 2018 College Football ... 8, 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... the AFHC "I,m In" campaign, participating in many activities leading ... ...
Breaking Medicine Technology: