FDA Updates Rules for NSAID Packaging to Include Specific Risks, Side Effects

FDA Updates Rules for NSAID Packaging to Include Specific Risks, Side Effects

July 10, 2015

Warning labels for certain over-the-counter (OTC) and prescription painkillers will soon include more information about their risks and potential side effects.

The Food and Drug Administration (FDA) this week announced that it is strengthening an existing warning for OTC and prescription nonsteroidal anti-inflammatory drugs (NSAIDs) to indicate that these medications can increase the chance of a heart attack or stroke.

These side effects can occur as early as the first few weeks of using an NSAID and the risk might rise the longer the medication is taken.

Prescription NSAIDs are often used as a treatment for osteoarthritis, rheumatoid arthritis‎, gout and other rheumatological and other painful conditions.

OTC NSAIDs are used to treat more minor aches and pains and temporarily reduces fever. NSAIDs include many common painkillers that are used regularly by consumers including ibuprofen (Motrin, Advil) and naproxen (Aleve).

NSAIDs can also be found in OTC products designed to treat multiple symptoms, like cold and flu medication, which often treats aches, pains, stuffy noses and coughing.

Aspirin is also considered an NSAID, but isn't affected by this labeling change.

"Be careful not to take more than one product that contains an NSAID at a time," the FDA's Karen Mahoney said in a statement.

NSAID packaging has included heart attack and stroke warnings since 2005, but the update will prompt manufactures to include more specific information about the side effects and when they can occur.

"There is no period of use shown to be without risk," the FDA's Judy Racoosin said in a statement.

Since people who have cardiovascular disease or who have recently had a heart attack or cardiac bypass surgery are at greater risk for side effects, the new drug label can help those patients make more educated and informed decisions about the medication they take.

"As always, consumers must carefully read the Drug Facts label for all nonprescription drugs," said Mahoney. "Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible."

The FDA says that those with heart disease or high blood pressure should consult a healthcare provider before using an NSAID. Consumers should weight the risks and benefits before taking any medication.

Stop taking NSAIDs and seek medical help if you experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.