FDA Strengthens Warning Labels on Over-the-Counter, Non-aspirin Painkillers

The U.S. Food and Drug Administration (FDA) has strengthened the warning labels for some over-the-counter, non-aspirin painkillers.

According to the FDA's website, the administration wants people, especially those with a history of heart attack or stroke, to be extra careful when taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen because these drugs can increase the risk of heart attack and stroke. Some common NSAIDs include Advil, Motrin and Aleve.

The new labels will change the wording from "may cause" to "cause" in regards to heart disease. The labels will also continue to tell patients to take the lowest dose possible for the least amount of time. People should not use these drugs for more than 10 days.

The FDA decided to strengthen the labels due to the amount of studies that have linked NSAIDs to an increased risk of heart attack, heart failure, stroke and death from cardiovascular issues. These studies have been published in respected journals, such as the British Medical Journal (BMJ) and The Lancet.

"Everyone may be at risk -- even people without an underlying risk for cardiovascular disease," Judy Racoosin, deputy director of FDA's Division of Anesthesia, Analgesia and Addiction Products, said.

Taking over-the-counter NSAIDs can still be effective just as long as patients follow these warnings.

"These medicines have a long history of safety and efficacy when used as directed," the Consumer Healthcare Products Association, which represents nonprescription drug makers, said in a statement.

The FDA warns people from taking more than one NSAIDs at a time and advises people to always keep an eye out for symptoms, such as sudden weakness in one part of the body, slurred speech, chest pain and breathing trouble. If these symptoms arise, stop taking the medications and seek medical care immediately.