The Food and Drug Administration is changing warning labels on many popular types of painkillers in an effort to curb their harmful effects. These drugs, while helpful to many people, can carry significant risks.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are being targeted by the FDA due to potential dangers from the painkillers. The new warnings underscore earlier warnings that NSAIDs could increase the risk of heart attacks or strokes, with a possibly fatal outcome.
Pain from arthritis and other conditions is often treated by NSAIDs, many of which are available without a prescription. These drugs can be a great help to people suffering from painful conditions, making daily life easier. People commonly use NSAIDs to reduce fever, treat headaches, menstrual cramps, toothaches, sprains and more.
Common medicines in this category include Aleve (Naproxen), Motrin and Advil (both brand names for ibuprofen), and many OTC drugs contain combinations of the drugs. Aspirin is the most popular NSAID pain reliever, but the updated warnings do not apply to that drug.
Many over-the-counter painkillers contain identical active ingredients. Because of this, a considerable number of people take more than the recommended dose.
The FDA is advising consumers to check the list of active ingredients on painkillers before taking them to ensure they are not consuming excess amounts of a single drug.
"Be careful not to take more than one product that contains an NSAID at a time," said Karen Mahoney, deputy director at the Division of Nonprescription Drug Products for the FDA.
Currently, NSAID pain relievers come with warnings about the risk of cardiac issues and strokes. The FDA will be requiring painkiller manufacturers to update their information concerning these potentially dangerous health issues.
Stomach issues can also result from the use of NSAIDs — although these problems can be avoided with the latest generation of over-the-counter pain relievers.
"COX-2 selective inhibitors are a newer type of medicine that primarily block the COX-2 enzyme. The only COX-2 selective inhibitor currently on the market in the United States is the prescription drug Celebrex (celecoxib)..." said Sharon Hertz, deputy director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.
"It was believed that COX-2 inhibitors may be less likely to cause the stomach problems associated with the older NSAIDs, but all NSAIDs carry the risk of stomach problems," she added.
People who have coronary artery disease, high blood pressure, or have had a stroke are at the greatest risk, as well as those who have just had cardiovascular bypass surgery.
Long-term continuous use of all NSAIDs, except for aspirin, may increase the risk of heart attack or stroke. Aspirin is a non-selective NSAID, and it has been shown in clinical trials to actually reduce the risks of cardiovascular events in patients who have cardiovascular disease or have already had a heart attack or stroke.
The FDA issued its first warnings of heart attacks and strokes from NSAIDs back in 2005. The updated warnings were triggered by new research showing a higher risk of heart attacks and strokes than previously estimated.
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