Thursday, July 9, 2009

Kramer votes to make Tylenol safer
By Kelly Shaw, DCRI Communications

Acetaminophen, the fever and pain reducer found in products such as Tylenol and many over-the-counter (OTC) cold and flu medications, is a safe and effective drug when you follow the recommended daily doses. But because acetaminophen is found in so many OTC products, people can unintentionally take more than the safe level of 4000 mg per day.

In addition to Tylenol, Nyquil, and many cold and flu medications, acetaminophen is also a key ingredient in Vicodin and Percocet, two frequently prescribed pain medications.

Because an estimated 110,000 emergency room visits per year are related to acetaminophen, a Food and Drug Administration (FDA) advisory panel recently met and came up with several recommendations to help improve overall safety with the medication. Consuming more than 4000 mg per day has been linked to liver problems, acute liver failure, and even death in some cases.

No evidence has been found that indicates taking the normal dose of acetaminophen will damage the liver.

Judith Kramer, MD, executive director of the DTMI's Clinical Trials Transformation Initiative (CTTI), is a member of the advisory panel that proposed changes for acetaminophen medications. The FDA does not have to act on the recommendations from the advisory panel but it often does. It has not yet taken action on the recommendations.

The panel recommendations include:

• Lowering the maximum daily dose of acetaminophen to 3250 mg, instead of the current maximum of 4000 mg. One dose would equal two tablets with 325 mg each of acetaminophen, with a maximum of five doses per day.
• Requiring a prescription for extra-strength doses (equal to two 500 mg pills) of acetaminophen
• Improving the labeling for OTC medications that contain acetaminophen to make it easier to see how much of the drug is contained in each dose.
• Removing acetaminophen from some prescription drugs such as Vicodin.

Kramer stressed that it is safe to take acetaminophen as long as you do the following:

• Don't combine medications that contain acetaminophen, such as taking Tylenol in addition to taking Nyquil.
• Follow label directions exactly.
• Don't take more than the maximum daily dose and don't take it for longer than the maximum number of consecutive days listed on the label, without first speaking to a doctor.
• If you have liver problems or drink alcohol daily, talk to your doctor about taking acetaminophen.

To read more about the recommendations, read this USA Today article.