Quantcast

FDA warns against prescription drugs with acetaminophen - 12 News KBMT and K-JAC. News, Weather and Sports for SE Texas

FDA warns against prescription drugs with high levels of acetaminophen

Updated: Jan 15, 2014 02:59 PM
© iStockphoto.com / Khuong Hoang © iStockphoto.com / Khuong Hoang
  • HealthMore>>

  • Too few teens receive HPV shot

    Too few teens receive HPV shot

    An "unacceptably low" number of girls and boys are getting the human papillomavirus (HPV) vaccine, which protects against cervical, anal and other cancers, U.S. health officials said Thursday.
    An "unacceptably low" number of girls and boys are getting the human papillomavirus (HPV) vaccine, which protects against cervical, anal and other cancers, U.S. health officials said Thursday.
  • Teenage boys want intimacy, not just sex

    Teenage boys want intimacy, not just sex

    The stereotype of the sex-crazed teenage boy may be dead wrong, according to a small study that asked boys what they really want from romantic relationships.
    The stereotype of the sex-crazed teenage boy may be dead wrong, according to a small study that asked boys what they really want from romantic relationships.
  • Bacteria in semen may affect HIV transmission, levels

    Bacteria in semen may affect HIV transmission, levels

    Human semen is naturally colonized by bacteria, and a new study suggests the microbes might have a role to play in both HIV transmission and levels in infected men.
    Human semen is naturally colonized by bacteria, and a new study suggests the microbes might have a role to play in both HIV transmission and levels in infected men.

WEDNESDAY, Jan. 15, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has asked doctors to stop prescribing painkillers that contain more than 325 milligrams of acetaminophen because of reports of severe liver damage.

Prescription painkillers, which include Vicodin and Percocet, are commonly given for pain following acute injuries, operations or dental procedures and they often contain acetaminophen. However, many over-the-counter medications also contain acetaminophen.

The FDA first tackled this issue in January 2011, when it asked drug makers to stop making prescription painkillers that contained more than 325 milligrams of acetaminophen per dose.

Accidental overdoses from using these products contributes to nearly half of all cases of acetaminophen-related liver failure in the United States, the agency said in a statement issued Tuesday.

Most cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product over a 24-hour period, took more than one acetaminophen-containing product at once and/or drank alcohol while taking the drug.

"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 Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in 2011. "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."

In 2011, the FDA gave drug makers three years to comply with its request to reduce levels of acetaminophen in prescription painkillers, and more than half have done so, the agency said Tuesday. Previously, such products could contain up to 750 milligrams of acetaminophen, according to U.S. health officials.

The agency noted that it will now take action to withdraw approval of any prescription painkillers that contain more than 325 milligrams of acetaminophen.

"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 told HealthDay in 2011. "[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."

The actions do not affect over-the-counter products containing acetaminophen such as Tylenol and Nyquil, although FDA officials have said the agency is considering taking action in that area as well.

Right now, over-the-counter products already carry warnings of possible liver damage on their labels.

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.

The FDA encourages 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.

Copyright © 2011 HealthDay. All rights reserved.

*DISCLAIMER*: The information contained in or provided through this site section is intended for general consumer understanding and education only and is not intended to be and is not a substitute for professional advice. Use of this site section and any information contained on or provided through this site section is at your own risk and any information contained on or provided through this site section is provided on an "as is" basis without any representations or warranties.
Powered by WorldNow

Newsroom: (409) 838-1212
Front Desk: (409) 833-7512
News Fax: (409) 981-1564
News Email: 12News@kbmt12.com

Powered by WorldNow
All content © Copyright 2000 - 2014 WorldNow and KBMT. All Rights Reserved.
Users of this site agree to the Terms of Service, Privacy Notice/Your California Privacy Rights, and Ad Choices.