Hyzaar is also used to lower the risk of stroke in certain people with heart disease. The advisory panel voted 16-9 against the assumption that naproxen has a lower risk of heart attack and stroke than similar anti-inflammatory medications, and cited a lack of conclusive evidence that the drug is safe for the heart. If you’re being treated for a heart condition, medicine cabinet staples such as aspirin and ibuprofen may not be good for you. Patients are advised to take the drugs for the shortest time period possible If the relabeling of naproxen sodium does take place, this could result in an explosion in sales for Bayer, and provide a competitive edge for them over rival pharmaceutical companies offering other NSAIDs.In 2004, Vioxx, a newer subset of NSAIDS, was pulled from the market due to concern about its potential to increase the risk of heart attack and stroke. "People shouldn't suffer unnecessarily, but it is important that people who take these drugs long term get guidance from a physician. RN.com members
Important Information. Current labeling warns that taking NSAIDs long-term can increase the risk of heart attack and stroke. Naproxen (brand names include Aleve and Naprosyn) doubled the risk of heart failure-related hospitalization. "It appears that there is a small increase in risk for certain NSAIDs under certain circumstances," says Luis A Garcia Rodriguez, MD. Pain Relievers Don't Increase Risk of Heart Attacks, Study ShowsNov. The FDA had initially recommended relabeling naproxen to emphasize its safety, yet the decision was reversed after 16 panel members opposed the recommendation.The safety review was initially prompted by a large study published last year that analyzed 350,000 patients who took various pain relievers. However, the FDA’s Advisory Panel met again a few weeks later to revise their recommendation. And this finding puts naproxen, a popular OTC drugstore painkiller, squarely in the “doghouse” as far as cardiovascular safety goes. Following this recall, the FDA increased its warnings about heart safety risks on all drugs in the class, including Motrin, Advil, Aleve and Celebrex (Perrone, 2014). "It has been just over a year since the popular prescription pain reliever Vioxx was pulled from the market amid concerns about an increase in Concerns have been raised about the long-term safety of more traditional anti-inflammatory pain relievers. However, FDA released early in 2014 a review that said naproxen may pose a lower risk of heart attack and stroke than ibuprofen. "Our study suggests either no effect or a small reduction of cardiovascular risk during sustained treatment with naproxen, a small increased risk with diclofenac, and an undetectable risk with ibuprofen," Garcia Rodriguez and Gonzalez-Perez wrote.The Wake Forest University cardiology professor co-authored a recent AHA advisory on the use of pain "We said that people should try to use the simplest and safest medications first in the recommended dosages for the shortest possible period of time," he tells WebMD.Ibuprofen, naproxen, and other NSAIDs should be used for "Every treatment decision is a balance of safety and efficacy, and this is certainly no different," Herrington says. You should not use this medicine if you are unable to urinate. Celebrex is available by prescription only.The FDA has also disclosed that it is considering halting a long-term study comparing the safety of naproxen, ibuprofen and Celebrex, as naproxen has already been shown to be safer for the heart than similar drugs, and the FDA does not want to expose trial participants to any further possible risk.While naproxen sodium is a relatively safe drug, there are many other medications that may present high risk to patients. In an effort to better understand the risks, Garcia Rodriguez and colleague Antonio Gonzalez-Perez of the Spanish Center for Pharmacoepidemiological Research assessed the short- and long-term use of NSAIDs as a class and also looked specifically at three of the most commonly used NSAIDs.Their findings are published in the Nov. 28 issue of the journal Close to 5,000 heart attack patients and 20,000 people who had not had heart attacks were included in the study.No increase in heart attack risk was seen among people who took moderate doses of ibuprofen, naproxen, or diclofenac for less than a year.Although the overall longer use (over a year) of all traditional NSAIDs was associated with a 20% increase in the risk for nonfatal heart attacks, the longer use of ibuprofen specifically appeared to have no impact on risk.Use of diclofenac demonstrated a small increased risk for Use of naproxen for longer than a year was associated with a slight decrease in heart attack risk, but it was not clear if the association was real.