The new warnings apply to acetaminophen, the popular pain medicine also known as Tylenol, and a class of drugs known as nonsteroidal anti-inflammatory drugs or NSAIDs, which include Bayer’s aspirin products, ibuprofen (the main ingredient in Johnson & Johnson’s Motrin and Wyeth’s Advil), naproxen and ketoprefen.

 

Acetaminophen is known for increased risk of liver damage while NSAIDs have long been blamed for internal bleeding especially in people who had stomach ulcers. This was the reason for which a new class of drugs was developed, known as COX-2 inhibitors. These drugs, which included Pfizer Inc's Bextra and Merck & Co Inc's Vioxx (both withdrawn from the US market), however, carried their own set of safety concerns, such as an increased risk of heart attacks and other cardiovascular problems. Only Pfizer's Celebrex remains on the U.S. market.

 

These drugs 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. 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 they know how to take these medications safely to reduce their risk,” said Dr. Charles Ganley, director of nonprescription drugs in the Center for Drug Evaluation and Research.

 

The warning added to a NSAID must read: “This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning or steroid drug, take other drugs containing prescription or nonprescription NSAIDs, have three or more alcoholic drinks every day using this product, take more or for a longer time than directed.”

 

The new rules also warn patients to quit taking these drugs medications if they experience signs of stomach bleeding, which including vomiting blood, feeling faint, having bloody or black stools, or stomach pains that do not get better.

 

Following the FDA request, Johnson & Johnson, Wyeth and Bayer released statements saying they would comply with FDA's order, adding that their products are safe and effective when taken as directed.

 

The FDA ruling comes ahead of a public FDA meeting in late June to discuss what other actions the agency could take to curb the risk of liver damage from products containing acetaminophen.