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Experts Urge Caution With Popular Painkillers After FDA Warning

Posted 10 Jul 2015 by Drugs.com

FRIDAY, July 10, 2015 – People who regularly reach for widely used painkillers like ibuprofen and naproxen may need to think carefully before they pop those pills, heart experts say. Mounting evidence has shown that chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) can raise a person's risk of heart attack and stroke. The evidence is strong enough that the U.S. Food and Drug Administration on Thursday ordered drug makers to toughen warning labels on both prescription and over-the-counter NSAIDs. The tougher warning does not include aspirin, an NSAID that has been shown to lower heart risks in some patients. Most people who occasionally take ibuprofen (Advil, Motrin) or naproxen (Aleve) for infrequent headaches or pain don't have to worry, as long as they follow the dosage directions on the bottle, said Dr. Richard Chazal, president-elect of the American College of ... Read more

Related support groups: Pain, Ibuprofen, Naproxen, Meloxicam, Celebrex, Diclofenac, Advil, Voltaren, Aleve, Mobic, Voltaren Gel, Motrin, Indomethacin, Toradol, Etodolac, Vicoprofen, Nabumetone, Flector, Flector Patch, Ketorolac

FDA Strengthens Heart Attack, Stroke Warning for Popular Painkillers

Posted 10 Jul 2015 by Drugs.com

THURSDAY, July 9, 2015 – The U.S Food and Drug Administration on Thursday strengthened the warning labels for widely used painkillers like ibuprofen and naproxen, saying they can increase the risk of heart attack or stroke. The FDA is asking people to think carefully about their use of nonsteroidal anti-inflammatory drugs (NSAIDs), particularly if they've already had a heart attack, according to a consumer update on the agency's website. The agency said it is taking this action based on recent data that shows the risk of heart attack or stroke can increase even after using NSAIDs for a short time. "They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke," FDA spokesman Eric Pahon told NBC News. In particular, people should avoid taking multiple products that contain NSAIDs, according to the revised FDA ... Read more

Related support groups: Ibuprofen, Naproxen, Meloxicam, Celebrex, Diclofenac, Advil, Voltaren, Aleve, Mobic, Voltaren Gel, Motrin, Indomethacin, Toradol, Etodolac, Vicoprofen, Nabumetone, Flector, Flector Patch, Ketorolac, Arthrotec

FDA Medwatch Alert: Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

Posted 10 Jul 2015 by Drugs.com

[Posted 07/09/2015] ISSUE:  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 FDAs comprehensive review of new safety information, FDA is 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. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal anti-inflammatory drug products. 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 ... Read more

Related support groups: Ibuprofen, Naproxen, Meloxicam, Celebrex, Advil, Diclofenac, Voltaren, Aleve, Mobic, Voltaren Gel, Motrin, Toradol, Indomethacin, Etodolac, Vicoprofen, Nabumetone, Flector, Flector Patch, Ketorolac, Arthrotec

FDA Medwatch Alert: COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Posted 7 Apr 2005 by Drugs.com

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on: * The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use. * Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. * Lack of any demonstrated advantages for Bextra compared with other NSAIDs. Patients currently taking Bextra should contact their physicians to ... Read more

Related support groups: Advil, Mobic, Toradol, Relafen, Lodine, Cataflam, Indocin, Feldene, Daypro, Ponstel, Ansaid, Dolobid, Actron, Nalfon, Clinoril, Amigesic, Tolectin, Aflaxen

FDA Medwatch Alert: COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Posted 15 Jun 2005 by Drugs.com

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on: * The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use. * Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. * Lack of any demonstrated advantages for Bextra compared with other NSAIDs. Patients currently taking Bextra should contact their physicians to ... Read more

Related support groups: Celebrex, Advil, Mobic, Toradol, Relafen, Lodine, Vioxx, Indocin, Cataflam, Feldene, Daypro, Ponstel, Ansaid, Dolobid, Actron, Nalfon, Clinoril, Amigesic, Bextra, Aflaxen

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