FDA Issues Strong Warnings Regarding Over-the-Counter Pain Medications - Here's What You Need to Know


Warning labels are required to divulge such information, but recently, the U.S. Food and Drug Administration has called for drug makers “to strengthen their warning labels” for over-the-counter medications by adding specific warnings about the increased risk of heart attack and stroke associated with these drugs.

Some of the medications affected by the change include ibuprofen (Motrin, Advil) and naproxen (Aleve), as well as some multi-symptom cold products. These medications are used for temporary relief from pain and fevers.

Since 2005, both prescription and over-the-counter labels for these pain medications have listed information about heart attack and stroke risk, but the FDA wants drug makers to get more specific about these risks.

Rick Williams, pharmacist at the Intermountain Sandy Clinic at Alta View Hospital, says that despite the vagueness of the labels, the change is a call for the public to take more responsibility in knowing the risks of the medications there are using.

“What the public needs to remember, is these medications aren’t just simple drugs,” says Williams. “They can do a lot of harm if used inappropriately. This change by the FDA also puts responsibility on doctors and providers to make sure patients know the risks and how they can be avoided.”

In a recent article by CNN, doctors that were interviewed were at odds with one another as to the effectiveness of this change and the specifics that labels can really offer at this time.

Some agree it was needed and others say the FDA acted to quickly. Both, however, agree that the updated instructions are vague and require more data before labels can offer even more specific information as to the heart attack and stroke risks.

“What patients need to know is, if you take the drugs, 'What is my risk of heart attack?' and that's not known yet," says Steven Nissen, MD, chief of cardiovascular medicine at the Cleveland Clinic.

Anna Steinberg, MD, an internist at DeKalb Medical, also thinks the warning is too vague and says she won’t stop telling patients to stop taking them, especially if they have no risk.

"I am not going to tell them to stop taking these," she says. She also believes that more data is needed and that this guidance creates, "way to much room for mass hysteria." 

After the FDA made the announcement, several drug manufacturers published statements regarding the effectiveness of their drugs, when used appropriately.

Bayer (manufacturer of Aleve)

"When taken as directed on the label, Aleve (naproxen sodium 220 mg) is a safe and effective pain reliever, used by millions of consumers since its introduction as an OTC product 20 years ago. Importantly, data collected for nearly 20 years indicates no signal (i.e. trend) for OTC naproxen sodium with regard to the occurrence of (cardiovascular) thrombotic and overall (cardiovascular) events. We will work with the FDA to incorporate additional label information as appropriate."

Pfizer (manufacturer of Celebrex and Advil)

"For over 30 years, extensive consumer use and several clinical studies have shown that Ibuprofen, when used as directed, is a safe and effective over-the-counter pain reliever delivered in a lower strength than prescription ibuprofen.

"We are committed to patient safety, and we will work with the FDA to make sure that new safety information is appropriately added to our packaging/drug facts label so that consumers can continue to safely use our products."

So there you have it. The new change isn’t anything ground breaking, but it does put added emphasis on our responsibility as users. Don’t use medications if you don’t need them, always use the label, and talk to your provider if you have questions.