The U.S. Food and Drug Administration (FDA) are requiring drug makers to strengthen their warning labels on top painkillers due to new information found regarding safety issues.
Drugs such as non-aspirin nonsteroidal anti-inflammatory drugs, NSAID’s, are being called on to update their labels to clearly identify a possible increased risk of a heart attack or stroke. They are typically used to relieve pain or fever from arthritis, flu and headaches.
The updated warnings apply to both over-the-counter strengths as well as higher doses that require a prescription by all brands including Celebrex, Advil, Naprosyn, Aleve and Daypro, according to CNN.
The FDA’s call for updated labels is called a drug safety communication, requiring labels to include, “the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. The risk appears greater at higher doses.”
They are also calling for the labels to say that the risk is not limited to patients with heart disease, but that those with heart disease have a higher risk.
At this time, the FDA does not think there is sufficient evidence to help them clearly determine if the risk is the same across the board for all NSAIDs.
Bayer, the manufacturer of Aleve, released a statement: “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.”
The manufacturer of Aleve was not the only company to release a statement in reaction to the new recommendations. Pfizer (manufacturer of Celebrex and Advil) released a statement saying:
“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.”
The new information from the FDA and the recommendation for a sterner warning on labels stemmed from an advisory committee the reviewed the medications along with the risks associated for cardiovascular events in 2014.
Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, says that he agrees with the FDA that there could be an increase in a patient’s risk for heart attack and stroke from taking these medications, but that the information behind these warnings is not sufficient or specific.
“We don’t have any good data,” Nissen said. Along with a group of his colleagues though, they are searching for more scientific data around the risk of these drugs and to what level these risks vary from drug to drug, and from dose to dose. Their trial, called The Precision trial, is funded by Pfizer.
