The FDA has announced that it will require new labels on both prescription and over-the-counter painkillers in the aspirin family, warning that even brief use of these drugs increases the risk of heart attacks and strokes, including among people with no heart disease risk factors.
The warning applies to all drugs in the non-steroidal anti-inflammatory drug (NSAID) family, with the exception of aspirin. Non-aspirin NSAIDs include those marketed under trade names such as Motrin, Aleve and Celebrex. The drugs are among the most widely used over-the-counter drugs, taken by millions each year in the United States alone.
But new research suggests that even small amounts can be deadly.
“One of the underlying messages for this warning has to be there are no completely safe pain relievers, period,” said Bruce Lambert of Northwestern University, a specialist in drug safety communication.
In its announcement, the FDA noted that NSAIDs have carried a boxed warning about the risk of heart attack and stroke since 2005. The new labeling rules, based on a further decade of research, strengthens those existing warnings.
Research has now shown that the risk of heart attack, heart failure or stroke can be increased even in the first weeks of NSAID use, and even among people with no prior heart disease risk. The risk is still much greater for those already at risk of heart attack or stroke, however. People who were given NSAIDs following a heart attack are also significantly more likely to die in the following year than people not given the drugs, studies have now shown.
The label will also specify that higher doses of NSAIDs lead to higher risks. It will note that different drugs may carry different risks, but that it remains unknown which are riskier. A clinical trial is currently under way to examine these variations.
Peter Wilson, an Emory University professor of medicine and public health, served on the FDA’s expert panel to evaluate the evidence on NSAIDs and cardiovascular risks. While cautioning that individuals vary widely in their response to different drugs, he offered the following rule of thumb for estimating the risk from non-aspirin NSAIDs: Over-the-counter doses (the lowest available) increase heart attack and stroke risk by about 10 percent; low prescription doses increase it by about 20 percent, and high prescription doses could increase risk by as much as 50 percent.
Such risk increases are especially dangerous for those over age 65 or who have other cardiovascular riskfactors, he warned.
“There is great concern that people think these drugs are benign, and they are probably not,” Wilson said. “The thought is these are good for short-term relief, probably for your younger person with no history of cardiovascular trouble.”
Avoid NSAIDs for minor aches, pains
The consensus among health experts and the FDA is that NSAIDs should only be used for short periods of time, and should not be used for minor pain or discomfort.
“The point of this warning is that we have to be very careful,” said cardiologist Sanjay Kaul of Cedars-Sinai Medical Center, who also served on the expert panel. “There has to be a good reason to take them. We shouldn’t just be using these drugs willy-nilly.”
Lambert noted that there are many non-pharmaceutical methods for managing many of the more minor complaints that people regularly rely on NSAIDs for. One of the most effective ways to get relief from arthritis symptoms, for example, is to lose weight.
“It’s a risk-benefit decision,” Lambert said.
“For people who are in the habit of taking these drugs for headaches or mild pain, they might want to reconsider.”
Stay Healthy – Healthyss Team !