Pain reliever or pain Factor? Posted On: Monday, Jul. 20 2009 06:20 AM By Alicia Lacy
Killeen Daily Herald

The Food and Drug Administration is in the process of addressing health concerns and possibly lowering the maximum dosages due to the potential health risks caused by the misuse of acetaminophen.

One of the most-used and distributed medicines in the country, acetaminophen is the generic name for the active ingredient in over-the-counter medicines like Tylenol.

Prior to the recent discussions on acetaminophen, the FDA issued its final rule on new labeling requirements in April for OTC manufacturers to comply with for acetaminophen and nonsteriodal anti-inflammatory drugs (NSAIDs), which include ibuprofen, aspirin, naproxen and ketoprofen that are in OTC drug brands like Bayer, Aleve, Advil and Motrin.

The new labeling standards, which drug manufacturers have to comply with by April 2010, requires manufacturers of those drugs to display active ingredients and potential risks for stomach bleeds on NSAIDs and liver damage for acetaminophen.

On June 29 and 30, the FDA's Drug Safety and Risk Management Advisory Committee with Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee met to address recent public health inquiries related to acetaminophen in both OTC and prescription drugs.

According to the FDA, there is little data on the specific maximum dose for toxicity; however, toxicity does vary from person to person.

Onset of symptoms related to liver injury can take several days and are often similar to flu symptoms.

"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches," Charles Ganley, director of the FDA's office of nonprescription drugs in the center for drug evaluation and research, said in a release. "However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk."

In response to the recent FDA advisory committee meetings, Edwin K. Kuffner, senior medical director-medical affairs for McNeil Consumer Healthcare, the distributor of Tylenol, said in a statement, "Tylenol, when it is taken as directed, remains the safest pain reliever people can take."

"It's important for people to know that it's not the recommended dosage that poses a risk," Kuffner said. "Rather, it's when people take more than the recommended dose either intentionally, often because they think it will work better – which is not the case – or unintentionally, often because they don't realize that several products they are taking at the same time (both prescription and OTC) each contain acetaminophen."

Reports state that many who overdose on the drug inadvertently take more acetaminophen than labeling recommends unknowingly or concurrently with prescription medicines that contain acetaminophen because it's usually labeled as its abbreviation APAP on prescriptions.