Pain Drugs Tylenol, Motrin and Advil to Carry Stronger Warnings

The FDA is requiring the manufacturers of many popular over-the-counter (OTC) pain drugs, such as Tylenol, Motrin, Advil and aspirin, to include prominent warnings on their labels about potential side effects like internal bleeding and liver damage.

The warnings will apply to any medications that include acetaminophen, the active ingredient in Tylenol, or drugs that are in a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin (marketed as Bayer), ibuprofen (marketed as Advil and Motrin), naproxen (marketed as Aleve, Naprosyn, Anaprox and Naprelan) and ketoprofen (marketed as Orudis and Oruvail).

Millions of Americans, both adults and children, use these drugs for pain relief and to reduce fevers. They are also commonly combined with other ingredients in many cold medicines.

Tylenol side effects have been associated with an increased risk for severe liver damage when more of the drug is taken than the label recommends or if multiple different drugs containing acetaminophen are taken together. The use of alcohol together with Tylenol or other acetaminophen drugs also could increase the risk of liver damage.

NSAID side effects could increase the risk for stomach bleeding when the drugs are used by people who are also taking blood-thinning drugs or steroids. The risk can also be increased if multiple different NSAIDs are taken at the same time, if they are taken longer than they are supposed to or if they are used together with alcohol.

“The risk associated with (the use of acetaminophen and NSAIDs) need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause,” said Charles Ganley, M.D., director of the FDA’s Office of Nonprescription Drugs, in a statement issued April 28, 2009. “It is important that they know how to take these medications safely to reduce the risk.”

Research has suggested that many users of these drugs often take more than the recommended dose contained on the warning label and often do not know that they are taking multiple products with the same ingredients. Many users are also unaware of the risk of using alcohol together with these over-the-counter pain killers.

In addition to requiring all manufacturers to warn about the risk of severe liver injury from acetaminophen and possible stomach bleeding with aspirin, ibuprofen, naproxen and ketoprofen, the FDA’s new rules will also require that labels placed on the bottles and packaging prominently display the active ingredients of these drugs.

The FDA is requiring all manufacturers to relable their products within one year. In addtion, an FDA advisory panel wll meet this summer to review the risk of liver damage associated with acetaminophen overdoses and to discuss what further steps may be necessary.