By AMERICAN HEART ASSOCIATION NEWS
Consumers soon will see new labels strengthening the warnings about the risk of heart attack and stroke on medicine commonly used for headaches, backaches, arthritis and even multi-symptom cold remedies.
The Federal Drug Administration issued an advisory this summer requiring all non-steroidal anti-inflammatory prescription drugs to revise their labels. The agency said it also will ask for the same for over-the-counter NSAIDs. The prescription form of the drugs include those used for arthritis relief, known as COX-2 inhibitors, sold by brand as Celebrex. The non-prescription drugs include ibuprofen, sold as Advil or Motrin, and naproxen, sold as Aleve.
Tylenol, known generically as acetaminophen, is not an NSAID. Aspirin, although considered an NSAID, is often used in low doses for heart attack prevention and is not included in the warnings. In fact, the FDA said consumers who take low-dose aspirin for protection against heart attack and stroke should know that some NSAIDs, such as ibuprofen and naproxen, can interfere with that protective effect.
“We’ve been concerned for a long time,” American Heart Association President Mark Creager, MD, said. “With this new warning, the public will be more aware about the risks and won’t be reaching so quickly for these drugs to treat aches and pains.”
The American Heart Association issued a statement in 2007 advising physicians to be wary of using COX-2 inhibitors and NSAIDs as a first line of defense in patients with heart disease or those at risk for developing it. It also called for more data and investigation into the heart safety of the drugs.
NSAIDs work to block enzymes called COX-1 and COX-2 that are responsible for manufacturing substances called prostaglandins, chemical messengers that can cause inflammation, pain and fever. Some of those same prostaglandins also help regulate blood clotting, protect the lining of the stomach and intestine and help with kidney function.
Doctors and researchers have been debating NSAIDs and their effect on the cardiovascular system for about a decade. The FDA first required the labels in 2005. Back then the labels said they might cause an increased risk of heart attack and stroke. The new warnings are more definitive, saying NSAIDs do have an increased risk.
The FDA issued a statement saying that risk can occur early in the treatment, even in the first weeks. And while people who have cardiovascular disease – especially those who recently have had a heart attack or bypass surgery – are at greatest risk with NSAIDs, the risk also is present for people who don’t have signs of the disease.
The FDA has been mulling over the warnings since February 2014, when it called together its advisory panel specializing in drug safety and another focusing on arthritis to consider whether new research warranted a label change. A research paper published in May 2013 in The Lancet concluded that people who take high doses of NSAIDs daily increase their risk of heart attack and stroke by as much as a third. The report analyzed data from more than 600 trials, including detailed case histories of more than 350,000 patients.
Creager, director of the Heart and Vascular Center at Dartmouth Hitchcock Medical Center, said it is good advice to take the lowest effective dose for the shortest amount of time. Any risks should be assessed as part of a conversation with a doctor, taking into account a person’s medical history.
“Make a reasoned decision based on what is known about the benefit of NSAIDs for the disease being treated,” he said.