The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels. 
 
 Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech. 
 
 NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs). 
 
 The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014. 
 
 Based on our review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information: 
 
 The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. 
 
 The risk appears greater at higher doses. 
 
 It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID. 
 
 NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied. 
 
 In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline. 
 
 Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack. 
 
 There is an increased risk of heart failure with NSAID use. 
 
 We will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of OTC non-aspirin NSAIDs. 
 
 In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class. 
 
 Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. We urge you to report side effects involving NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page. ||||| RALEIGH, N.C. (WNCN) – For the last several years, the FDA has warned that ibuprofen, Naproxen and other NSAID-type painkillers may cause an increased risk for heart disease and stroke. 
 
 Now the FDA has strengthened its warning for these drugs and says that these agents absolutely do raise the risk for heart attack and stroke. 
 
 The FDA said it reviewed a large number of studies that supported the conclusion that the medicines caused increased risk. The studies estimated that the relative risk increased by 10 percent to 50 percent, depending on the drugs and the doses considered. 
 
 The new FDA warning covers drugs called nonsteroidal anti-inflammatory drugs or NSAIDS for short. They include ibuprofen, sold under brand names like Advil or Motrin; naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors, such as Celebrex. 
 
 Ibuprofen and other NSAIDs work by inhibiting production of prostaglandins—(by inhibiting an enzyme called cyclooxygenase). Prostaglandins are chemicals released by injured cells that trigger inflammation and pain. It is important to remember that Tylenol, known generically as acetaminophen, is not an NSAID and works in a different way. It is not included in this new FDA warning. Tylenol also has potential health risks and this includes liver damage and toxicity when taken in very high doses. 
 
 Prescription NSAIDs are an important treatment for the symptoms of many debilitating conditions, including arthritis, rheumatoid arthritis‎, gout and other rheumatological conditions. 
 
 NSAIDs are used to temporarily reduce fever and to treat minor aches and pains such as headaches, toothaches, backaches, muscular aches, tendonitis, strains, sprains and menstrual cramps. 
 
 Remember that in addition, some combination medicines that relieve various symptoms, such as multi-symptom cold products, contain NSAIDs. 
 
 According to an FDA spokesman, the “FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) drug facts labels to indicate that non-steroidal anti-inflammatory drugs can increase the chance of a heart attack or stroke, either of which can lead to death.” 
 
 The FDA has carefully reviewed the data for the last year and has found that in numerous studies it has been clear that the use of NSAIDS is associated with an increased risk for heart disease and stroke. 
 
 Some of the studies they looked at showed a clear pattern: people who took NSAIDS were more likely to have heart attacks or strokes. Many of the researchers found that the time course of the development of heart disease can be both early and late in the course of starting NSAIDS. 
 
 The FDA added a boxed warning to prescription drug labels for the increased risk for heart disease and stroke in 2005. More recent data has now prompted the FDA to update NSAID labeling. 
 
 Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks. People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs. This particular population is at very high risk—they are quite vulnerable and should avoid NSAIDs when possible. 
 
 The bottom line is that NSAIDs are effective treatments for pain, inflammation and fever. 
 
 Consumers can still take them but should be aware of this increased risk of heart attack or stroke, especially at higher doses. 
 
 If you have heart disease or high blood pressure, talk with your doctor before using an NSAID. 
 
 Together, with your doctor, you must balance the benefits of NSAIDs with the possible risks. 
 
 Seek urgent medical attention and stop taking NSAIDs if you experience symptoms that might signal heart problems or stroke — chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech. If you take these drugs, take the smallest effective dose. 
 
 To get in touch with Dr. Campbell, you can head to his website, Facebook page or message him on Twitter. ||||| Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used over-the-counter drugs to relieve pain or reduce fever, but new research suggests people who take them routinely could face a higher risk of a heart attack. 
 
 The study, published in The BMJ, found that all commonly used NSAIDs – ibuprofen and naproxen, which are available over the counter; and diclofenac and celecoxib, which require prescriptions in the U.S. – were associated with this increased risk. 
 
 While the absolute risk of having a heart attack after taking this medication is very small, experts say consumers should exercise caution when deciding whether or not to take NSAIDs, particularly people who are already at risk for heart trouble. 
 
 "I think this study is another cautionary tale to be very careful before using these drugs and not be lulled into a place of complacency just because they're over the counter," Deepak Bhatt, M.D., executive director of interventional cardiovascular program at Brigham and Women's Hospital, told CBS News. "If someone has to use an NSAID for pain relief, the best advice is to use the lowest possible dose and for shortest amount of time possible." 
 
 Previous research has linked the use of NSAIDs to an increased risk of heart attack, but the timing of the risk, the effect of dose, treatment duration, and the comparative risks between different NSAIDs were poorly understood. 
 
 For the study, an international team of researchers led by Michèle Bally of the University of Montreal Hospital Research Center, who was then an epidemiology doctoral student at McGill University in Canada, carried out a systematic review and a meta-analysis of studies from health care databases in Canada, Finland and the United Kingdom. 
 
 Collectively, they analyzed data on 446,763 people, of whom 61,460 had a heart attack. 
 
 The results showed that heightened risk of heart attack occurred as early as in the first week of taking an NSAID, and the risk was greater with higher doses of NSAID. 
 
 The greatest risk of heart attack was seen with NSAID use at a high daily dose in the first month. High daily doses include: 
 
 Celecoxib (Celebrex) > 200 mg 
 
 Diclofenac (Voltaren, Cambia, Solaraze) > 100 mg 
 
 Ibuprofen 
 
 Naproxen (Midol, Aleve, Naprelan) > 750 mg 
 
 Overall, the results showed a 20 to 50 percent increase in risk of a heart attack when using NSAIDs compared with not using these medications. 
 
 However, Bally emphasizes that the absolute risk is very small and will vary based on patient's baseline risk. 
 
 "These numbers do not mean that a person has a 20 to 50 percent risk of having a heart attack after taking those drugs," she told CBS News. 
 
 Rather, the findings mean that as a result of this increase, the risk of heart attack due to NSAIDs is on average about 1 percent annually, she said. 
 
 Bhatt, who was not involved in the study, offers some more perspective. 
 
 "Someone who is young and healthy and takes an NSAID for a sprained ankle, the risk of heart attack is already very low so it raises the risk from very low to very low," he said. "On the flip side, an 80-year-old who has high blood pressure, who's had bypass surgery, for that patient, the risk could be substantial." 
 
 The study also looked at long-term use of NSAIDs and found that the heightened risk did not seem to continue to increase even further when people took them for longer than one month. However, Bally said this should be interpreted with caution since the authors did not study repeat heart attacks; she advised it's still best to use NSAIDs for the shortest time possible. 
 
 The study was observational and cannot prove that taking NSAIDs actually causes a heart attack. The researchers note another limitation of the study is that not all the factors that could potentially influence risk could be taken into account. 
 
 The research doesn't explain underlying reasons for the link, but experts have some theories. 
 
 "Other studies show that NSAIDs can raise blood pressure and lead to fluid retention," Bhatt said. "These sorts of things can help precipitate a heart attack, particularly in people who are already vulnerable to it." 
 
 Previous research has also shown these medications may put people at risk for blood clots. 
 
 Experts say the study is not meant to scare people away from using NSAIDs, but rather to be more mindful when using them. 
 
 "If someone needs to treat occasional pain, fever, or inflammation they should consider all available treatment alternatives and get the help of the health care providers," Bally said. 
 
 She notes that people taking these drugs for chronic pain may want to consider whether the benefit of increasing the dose for better relief outweighs a possible increased risk of heart attack. They could talk to their doctors about other avenues of treatment such as physical therapy or local injections. 
 
 "The bottom line is, don't treat these drugs like candy just because they're sold over the counter," Bhatt said. "Treat them like any medications. Only use them if you really need to, lowest dose possible, for least amount of time." ||||| Español 
 
 Subscribe: FDA Consumer Health Information 
 
 Next time you reach into the medicine cabinet seeking relief for a headache, backache or arthritis, be aware of important safety information for non-steroidal anti-inflammatory drugs. 
 
 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. Those 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 NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.) 
 
 The OTC drugs in this group are used for the temporary relief of pain and fever. The prescription drugs in this group are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient. 
 
 The Risks and What’s New 
 
 Prescription NSAIDs are an important treatment for the symptoms of many debilitating conditions, including osteoarthritis, rheumatoid arthritis‎, gout and other rheumatological and painful conditions. OTC NSAIDs are used to temporarily reduce fever and to treat minor aches and pains such as headaches, toothaches, backaches, muscular aches, tendonitis, strains, sprains and menstrual cramps. Common OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve). In addition, some combination medicines that relieve various symptoms, such as multi-symptom cold products, contain NSAIDs. 
 
 “Be careful not to take more than one product that contains an NSAID at a time,” says Karen M. Mahoney, M.D., deputy director of FDA’s Division of Nonprescription Drug Products. How will you know? Check the list of active ingredients in the Drug Facts label. 
 
 The labels for both prescription NSAIDs and OTC NSAIDs already have information on heart attack and stroke risk. In the coming months, FDA will require manufacturers of prescription NSAIDs to update their labels with more specific information about heart attack and stroke risks. FDA will also request that the manufacturers of OTC NSAIDs update the heart attack and stroke risk information in Drug Facts labels. 
 
 FDA added a boxed warning to prescription drug labels for this risk in 2005. More recent data and information are prompting FDA to update NSAID labeling. Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks. 
 
 “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. 
 
 People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs. 
 
 FDA is adding information in the drug label for people who already have had a heart attack. This vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they’re treated with NSAIDs, according to studies. 
 
 But the risk is also present in people without cardiovascular disease. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” Racoosin adds. 
 
 What Consumers Should Do 
 
 NSAIDs are effective treatments for pain, inflammation and fever. Consumers can still take them but should be aware of this increased risk of heart attack or stroke, especially at higher doses. 
 
 “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,” Mahoney says. 
 
 When using prescription NSAIDs, read the consumer-friendly Medication Guide attached to your filled prescription, which provides important safety information. 
 
 If you have heart disease or high blood pressure, consult a health care provider before using an NSAID. Balance the benefits of NSAIDs with the possible risks and weigh your options. If you take low-dose aspirin for protection against heart attack and stroke, you should know that some NSAIDs, including ibuprofen and naproxen, can interfere with that protective effect. 
 
 Stop taking NSAIDs 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. 
 
 Reduce your risk factors for heart disease and stroke. “Smoking, high blood pressure, high cholesterol and diabetes are significant risk factors for these conditions,” Mahoney says. “If you smoke, work on quitting. See your doctor regularly to find out if you have these other strong risk factors, and commit yourself to taking care of them and of your health.” 
 
 July 9, 2015 
 
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– The FDA advised back in 2005 that non-aspirin nonsteroidal anti-inflammatory drugs, or NSAIDs, could up the risk of heart attack and stroke. But the agency is now boosting that warning, noting that drugs like ibuprofen (often sold under the Motrin IB brand), naproxen (Aleve), and celecoxib (Celebrex) may pose a risk even in small amounts and that these drugs should be used sparingly and for short periods, the New York Times reports. (Aspirin, although an NSAID, doesn't pose the same risk, the FDA notes.) Although an FDA review found that higher doses increased the risk of heart attack or stroke—and the risk may increase with length of use—"there is no period of use shown to be without risk," an FDA deputy director says. And while people with cardiovascular disease are more at risk for being adversely affected by NSAIDs, "everyone may be at risk—even people without an underlying risk for cardiovascular disease," the FDA rep says. NSAIDs decrease production of prostaglandins, chemicals spewed out after an injury that trigger inflammation, WNCN reports. Per the FDA review, over-the-counter NSAIDs could up the risk of heart attack and stroke by about 10%, low-dose prescription meds by 20%, and higher-dose prescription NSAIDs by 50%, with "significant variability" in each estimate, an Emory University medical professor tells the Times. One NSAID, Vioxx, was taken off shelves in 2004 after being linked to 140,000 heart attacks over a five-year period, Bloomberg notes. The director of Northwestern University's Center for Communication and Health says that "one of the underlying messages (is) there are no completely safe pain relievers, period." How to cut down on potential NSAID risks, per the Harvard Health Blog: Take the lowest dose that works, limit how long you take it, and never take more than one NSAID at once. (Meanwhile, Benadryl may up your risk for Alzheimer's.)