The U.S. Food and Drug Administration has strengthened the warning on prescription and over the counter non-steroidal anti-inflammatory drugs (NSAIDs) to indicate that use of these drugs, even short term use, carries a risk of heart attack and stroke which may lead to death.
Most NSAID pain relievers are available only by prescription. However, ibuprofen (Motrin, Advil) and naproxen (Aleve) are available in lower doses over the counter without a prescription and are widely used by the public to treat minor aches and pains such as headaches, muscle aches, toothaches, backaches, strains, sprains and menstrual cramps. These drugs are also commonly found in combination medicines such as cold and flu products.
Prescription NSAID Drugs
|Generic Name||Brand Name|
|Diclofenac||Zorvolex, Zipsor, Flector, Cataflam®, Voltaren®, Voltaren gel, Arthrotec™ (combined with misoprostol), PENNSAID® 1.5%, PENNSAID|
|Etodolac||Lodine®, Lodine® XL|
|Fenoprofen||Nalfon®, Nalfon® 200|
|Ibuprofen||Motrin®, Tab-Profen®, Vicoprofen®* (combined with hydrocodone), Combunox™ (combined with oxycodone), Duexis (combined with famotidine)|
|Indomethacin||Indocin®, Indocin® SR, Indo-Lemmon™ , Indomethagan™|
|Naproxen||Naprosyn®, Anaprox®, Anaprox® DS, EC-Naproxyn®, Naprelan®, Naprapac® (copackaged with lansoprazole), Treximet (combined with sumatriptan succinate) and Vimovo (combined with esomeprazole magnesium)|
|Tolmetin||Tolectin®, Tolectin DS®, Tolectin® 600|
A boxed warning about increased risk of heart attack and stroke was added to prescription NSAID pain relievers in 2005 and current labeling for over the counter NSAIDs states in the Drug Facts that risk of heart attack and stroke may increase if using more than directed or for longer than directed.
The FDA said the agency will now require manufacturers to update labels of prescription NSAIDs with more specific information about heart attack and stroke risks and will request manufacturers of over the counter NSAID products to update the Drug Facts on the label to warn that these serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take them.
“There is no period of use shown to be without risk,” says Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
The FDA said the changes were prompted by review of new data from studies, clinical trials and scientific publications.
While people with heart disease and those who have recently suffered a heart attack or undergone cardiac bypass surgery are at greatest risk of heart attack or stroke following NSAID use, a large number of studies confirmed these drugs can increase the risk of heart attack or stroke in people with or without heart disease or risk factors for heart disease.
In a consumer update, the FDA said NSAID drugs are effective treatments for pain, inflammation and fever, but that people must weigh the benefits of these drugs against the possible risks. The agency advised people who have heart disease or high blood pressure, consult a health care provider before using an NSAID.
Stop taking an NSAID drug and seek medical help if you experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.
Although aspirin is also an NSAID, this revised warning does not apply to aspirin. People who take low-dose aspirin for protection against heart attack and stroke should know that some NSAIDs, including ibuprofen and naproxen, could interfere with that protective effect.
If using a prescription NSAID drug, read the Medication Guide attached to your filled prescription for important safety information.
“As always, consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible,” says Karen M. Mahoney, M.D., deputy director of FDA’s Division of Nonprescription Drug Products.
Consumers should avoid taking more than one NSAID product at a time.