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Paracetamol prescriptions to come with new warnings

01/14/2011 13:40:00 admin

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by Aimee Keenan-Greene

The U.S. Food and Drug Administration will now require Paracetamol or Acetaminophen manufacturers to update prescription drug labels to warn of the potential risk of severe liver injury from an over dose of painkillers containing this ingredient like Percocet, Tylenol 3 and Vycodin.

And that's not all, prescription combination products that contain acetaminophen will have to limit Paracetamol to no more than 325 milligrams (mg) in each tablet or capsule.

Acetaminophen, also called APAP, relieves pain and fever and is found in both prescription and over-the-counter (OTC) products. 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).

An FDA advisory committee discussed this issue back in June of 2009 and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing Paracetamol.

The elimination of higher-dose prescription combination Paracetamol products will be phased in over three years and should not create a shortage of pain medication.

“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 Kweder. "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.”

Acetaminophen or Paracetamol, widely used as an over-the-counter pain and fever medication, is often combined with cough and cold ingredients.

Because of continued reports of liver injury, FDA issued their strongest warning for prescription drugs be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking Paracetamol products.

"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.”, Kweder added.

OTC acetaminophen products are not affected by today's FDA decision.

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.

According to the Mayo Clinic, if you give your child acetaminophen, height and weight matter. Too much Paracetamol overloads the liver and could be life-threatening.

Rhode Island Hospital, a Lifespan partner says parents should not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years old.

These guidelines from the American Association of Poison Control Centers:

Age 5 and younger. Seek emergency care if your child age 5 or younger swallows 91 milligrams (mg) of acetaminophen per pound of his or her weight (200 mg per kilogram, or kg) in 24 hours.

Age 6 and older. Seek emergency care if your child age 6 or older swallows 91 mg of acetaminophen per pound of his or her weight (200 mg per kg) or at least 10,000 mg of Paracetamol — whichever is less.

Click here for the complete toxic dosage chart.