Acetaminophen limits recommended by FDA

[Clark]

http://abclocal.go.com/kabc/story?section=news/health&id=9401382

Acetaminophen limits recommended by FDA
Denise Dador

You might say it's just a common pain reliever we all use, but doctors want you to know how quickly acetaminophen can become a toxic dose. Some doctors are calling it a serious health crisis.

Overdosing on acetaminophen is the number-one cause of liver failures in the U.S. today. Surveys show a quarter of Americans take more than the recommended amount of pain pills than they should. The government is taking steps to restrict dosing, but local liver transplant specialists say that's not enough.

At UCLA's liver transplantation program, surgeons have transplanted more than 300 patients due to acetaminophen acute liver failure.

"And that's a significant number of patients undergoing transplantation for a single drug toxicity," said Dr. Ronald Busuttil, Ronald Reagan UCLA Medical Center.

Two-thirds of them are adults. A third are children. Busuttil, chief of UCLA's liver transplant service, says when you consume too much, it clogs of the blood vessels of the liver, resulting in cell death.

"And then when the liver cells die, the patients get jaundiced, their blood does not clot, they get what we call hepatic encephalopathy, they can't think, they can't converse, they can go into a coma, and that's because of liver failure," said Busuttil.

Last week, U.S. health regulators recommended doctors stop prescribing drugs that contain more than 325 milligrams of acetaminophen, but the guideline doesn't cover over-the-counter meds.

Americans should not exceed more than 4,000 milligrams a day, which is equal to eight Tylenol pills, but people exceed the daily amount because they're unaware other combination therapies such as NyQuil, Excedrin, Sudafed, Robitussin and Benadryl also contain acetaminophen.

"And I think it not only should be restricted to prescription medications, which I think is a great accomplishment that has happened, but it should also apply to over-the-counter medications," said Busuttil.

The FDA says consumers should not take more than the prescribed dose of any medication that contains acetaminophen. And you should not take more than one acetaminophen product at a time.

Drinking alcohol while taking these medications also puts you at added risk.

[Clark]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

[Posted 01/14/2014]

AUDIENCE: Consumer, Dentistry, Emergency Medicine, Internal Medicine, Pharmacy, Pain Management, Surgery

ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.
 
Cases of severe liver injury with acetaminophen have 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.

BACKGROUND: In January 2011 FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. FDA will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.

More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. In the near future FDA intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

RECOMMENDATION: FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. FDA also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.

Health care providers and pharmacists who have further questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or druginfo@fda.hhs.gov.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/14/2014 -  FDA Statement - FDA]
[Acetaminophen Information - FDA]
Previous MedWatch Alert:

[01/13/2011 - Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit - FDA]