FDA Strengthens Heart Safety Labels to Warn Consumers About the Risk of Pain Relievers
The Food and Drug Administration announced that it plans to strengthen the warning labels on painkillers like to notify consumers about their risks of heart attack and stroke by using ibuprofen and NSAIDs.
Federal health regulators released a statement on Thursday about the new warnings on pain relievers. This includes popular over-the-counter drugs like Advil and Motrin along with prescription non-steroidal anti-inflammatory drugs, or NSAIDs, which are commonly found in cough and cold remedies.
"FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death," the agency said in a statement.
As of now, language on the labels warn that they can increase the risk of heart-related problems if used on a long term basis. However, the new FDA warning states that heart attacks and strokes can occur within the first few weeks of consumption. The agency also warns that the risks increase when people use higher doses of the drugs.
"They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke," FDA spokesman Eric Pahon told NBC News.
"In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke," the agency notes in a statement, according to The Associated Press.
"Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient," the FDA said.
Recent FDA studies also show a clear correlation between people who took NSAIDS and the increase chance that they would have a heart attack or strokes.
"There is no period of use shown to be without risk," said Dr. Judy Racoosin, deputy director of FDA's Division of Anesthesia, Analgesia and Addiction Products.
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