On Thursday, the Food and Drug Administration made a movement to place stronger warnings about the risks of painkillers on labels. After reviewing new evidence regarding health dangers, the FDA is reconsidering the way over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) are marketed to the public. Drugs like ibuprofen, most commonly sold as Advil, and naproxen, known as Aleve, already contain warnings that say they “may cause” an increased risk of heart attack and stroke. New labels, however, will make the link explicit, stating that they “cause an increased risk” of heart attack and stroke.
Countless studies from the past have proven that painkillers come with a series of health problems in addition to their relief. A 2013 study examined 600 trials and found that high doses of NSAIDs increase the risk of heart attacks by one-third. What’s more, ibuprofen was found to more than double the likelihood of a major coronary event. All types of NSAIDs saw a two- to four-fold increased risk of gastrointestinal problems. Even more concerning, a 2014 study found that deaths associated with strokes were 19 percent higher in patients who had been taking NSAIDs.
The FDA first warned of the risks associated with OTC painkillers in 2005, but is now tightening its belt thanks to new evidence. Overall, it found that the risk of heart problems is present indiscriminate of the duration taking the drugs or previous health issues. “There is no period of use shown to be without risk,” said Dr. Judy Racoosin, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products in a statement.
Previous studies have proven that the risk increases when NSAIDs are used in higher doses. Also, the FDA states that those who have underlying heart disease are at an even greater risk of complications. That being said, health hazards exist for everyone. “Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks,” the FDA says.
The FDA also plans to put additional warnings for those who have preexisting heart problems, and have experienced a heart attack in the past. “This vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they’re treated with NSAIDs, according to studies,” the FDA said.
In order to minimize chances of experiencing heart complications when taking these painkillers, the FDA recommends that you should take the drug at the lowest dose possible, over the shortest span of time you can. Also, it is advised that you consult a doctor to see if you have preexisting high blood pressure or symptoms of possible heart disease.
Source: Schmidt M, Sørensen H, Petersen K, et al. Preadmission use of nonaspirin nonsteroidal anti-inflammatory drugs and 30-day stroke mortality. Neurology. 2014.
Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomized trials. The Lancet. 2013.