FDA officials announced in a July 9 Drug Safety Communication(www.fda.gov) that the agency is directing manufacturers of all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) to update their product labels to clearly indicate these analgesic medications increase users’ risk for cardiovascular thrombotic events, including myocardial infarction and stroke.
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NSAIDs are typically given to relieve pain or fever that results from, but not limited to, arhtirits, flu, headaches and menstrual cramps. The warning applies to both.
Advil is marketed by Pfizer Inc., while Aleve is sold by Bayer. They are not intended to be used for pain longer than 10 days, according to their labels.
NSAIDs include ibuprofen, naproxen sodium and celecoxib. The group said it would cooperate with the FDA as it requests updates to the labels.
The warning from the agency said that in the first few weeks of taking an NSAID, a person’s risk of developing heart attack and stroke would increase.
Consumers can still take them but should be aware of this increased risk of heart attack or stroke, especially at higher doses. “The risk is high with regular use, and it’s likely that the risk is greater when higher doses of these drugs are used”. It is unclear from the available data whether the risk for these events is similar for all non-aspirin NSAIDs, but the increased risk is observed most consistently at higher doses. There is also an increased risk for heart failure associated with these medications. FDA had already placed information regarding the risks of many OTC and prescription NSAIDs. Last week it took the unusual step of further strengthening this warning.
The stronger warning for NSAIDs builds on the larger warning requirements that were included on labels in 2005, after the drug rofecoxib, commonly known as Vioxx, was pulled from the market when studies confirmed increased heart attack and stroke risk.
“These drugs are hard on the kidneys and make people vulnerable not only to heart attacks, but to kidney failure as well”, he said.
Nissen told CNN, “the writing has been on the wall for a long time”. It relieves pain but does not appear to increase heart attack or stroke risk. On the heels of that, another COX-2 inhibitor, Bextra, was withdrawn.
Previous studies have suggested that naproxen may be safer than other types of NSDAIDs, but the new evidence reviewed by the expert panel isn’t solid enough to determine that for certain.
Try alternatives to NSAIDs such as acetaminophen. She believes the FDA should have waited until it could offer more definitive guidance, saying this creates, “way to much room for mass hysteria”.
Mahoney also added that consumers should go for the lowest effective dose and take them at the shortest duration possible. He says people should not be afraid to take ibuprofen but if you have heart disease you should be more cautious.
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If you experience chest pain, shortness of breath, or sudden weakness or difficulty speaking while taking an NSAID, seek medical help immediately.
