FDA Calls for Stricter Warning Labels for Painkillers

Popular Pain Pills May Come With Greater Risk of Heart Attack, Stroke

The U.S. Food and Drug Administration (FDA) announced recently that many popular painkillers sold over the counter should come with warnings of increased risk of heart attack and stroke.

In the light of new safety information, the FDA believes that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) should carry greater warning labels. NSAIDs encompass many popular pain relief pills including Aleve, Advil, Celebrex, Naprosyn, and more.

The Popularity of NSAIDs

Millions of Americans reach for that little bottle of Advil or Aleve when they're in pain. For anything from headaches to muscle aches to menstrual cramps, these over-the-counter pills offer relief to many.

However, some studies suggest that prolonged usage may lead to an increased risk of heart attack or stroke. Aleve manufacturer, Bayer, issued a statement saying, "When taken as directed on the label, Aleve is a safe and effective pain reliever, used by millions of consumers since its introduction as an OTC product 20 years ago."

Bayer goes on to say that it will continue to work with the FDA to provide adequate safety labels. However, they also contend that their independent research shows no correlation between increased risk of heart attack and stroke with use of their NSAID.

It's long been prescribed to patients with a history of heart disease to consider taking a low dosage of aspirin with prevent future heart attacks. However, with this new report coming from the FDA, it might cause confusion regarding which pills can really help prevent heart disease.

Adding Warning Labels

Advil, Aleve, and many other NSAIDs are not new to the market. So how were these drugs approved without a warning label in the first place? It's because these common pain relievers have been around for 30 years or more. The testing procedures for the FDA have changed greatly since then, and data has been slow to trickle in.

However, many doctors and researchers believe that more data is needed to fully understand the effects of NSAIDs on patients. In fact, patients suffering from congestive heart failure and high blood pressure are often instructed to find an alternative to NSAIDs. Higher doses and prescriptions of these painkillers already carry the warning label.

Pfizer, manufacturer of Advil and Celebrex, is currently conducting a trial with over 24,000 patients taking different types of pain relievers. This study began in 2007 and is set to conclude sometime next year. More data will help the FDA specify its concern over the drugs.

Pay Attention to Warning Labels

Always read the warning labels printed on any prescription or over-the-counter drugs you take. Never exceed the recommended dosage and contact your physician if you have questions about a certain medication.

If you believe you were injured because a drug didn't carry the correct warning label, you can find more information in the dangerous drugs section of our website to see if there's already a lawsuit against the manufacturer.