FDA Orders Stronger Safety Warnings for Tylenol, Motrin, and Advil

Tylenol, Motrin, and Advil and other popular brands of over-the-counter painkillers and fever-reducers that millions of people take every day for headache and muscle pain must carry stronger warnings about the risks of liver damage and stomach bleeding, the Food and Drug Administration has ordered.

Drugs like Tylenol which contain acetaminophen must now include prominent warnings on their packaging to notify users that too much of the drugs can cause severe liver damage. Users also will be warned against taking the drugs with excessive amounts of alcohol, the FDA said.

Also, drugs which belong to another class of painkillers called non-steroidal anti-inflammatory drugs, or NSAIDs, also will be required to include bolder warnings about the risks of stomach bleeding on their packaging. NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen as well as big-name brands such as Advil, Motrin, and aspirin products made by Bayer AG.

Increased Risks of Stomach Bleeding, Kidney Damage

People who take NSAIDs while also taking blood-thinning drugs (also called anticoagulants) or steroids may be at increased risk of stomach bleeding, the FDA warned. Also, stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, who take them longer than directed, or who consume alcohol while using the drugs, according to the FDA

“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,” said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “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.”

Millions of Consumers May Need to Reconsider Drug Use

The FDA issues dozens of similar warnings and changes in existing safety warnings to drug packaging every year, but seldom does the agency order such bold warnings to over-the-counter drugs taken by so many Americans, young and old, for so long. The names of the drugs involved in today’s FDA announcement are likely to be found in just about every medicine cabinet or office medical supply cabinet across the United States.

As a result of today’s FDA action, millions of people must now more carefully consider the risks and benefits of the drugs they have come to rely on for so long.

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