... 1 EC-NAPROSYN ® (naproxen delayed-release tablets) 2 NAPROSYN ® (naproxen tablets) 3 ANAPROX / ANAPROX ® DS (naproxen sodium tablets) ® 4 NAPROSYN ® (naproxen suspension) 5 Rx only 6 Cardiovascular Risk · NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS). · Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Gastrointestinal Risk · NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). DESCRIPTION 7 8 Naproxen is a proprionic ...

... Naproxen-Patient Information Sheet Does Naproxen Interact with other Drugs or Food? This is a summary of the most important information about naproxen. For details, talk to your healthcare provider. Tell your healthcare provider about all the medicines you take, FDA Alert [12 / 23 / 04 ]: Based on emerging including prescription and non-prescription medicines, vitamins, information, the risk of cardiovascular and and herbal supplements. Your healthcare provider may have to cerebrovascular events may increase among adjust your dose or watch you more closely if you take any of the following medications: patients taking naproxen. FDA recommends · Certain blood pressure medicines called ACE inhibitors patients not exceed the recommended dose. · Furosemide (Lasix) For more information about these risks, refer · Lithium to the FDA Alert for Healthcare Providers. · Methotrexate · Warfarin (coumadin) What Is Naproxen? · Aspirin · Other NSAIDs Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used as a pain reliever / fever reducer. Are There Other Risks? It is available over the counter for: · Headache Naproxen ...

... FDA Alert for Healthcare Providers Naproxen FDA Alert [12 / 23 / 04 ]: Based on emerging information from a long-term prevention trial, the risk of cardiovascular and cerebrovascular events may increase among patients taking naproxen. FDA will be analyzing all available information from these studies to determine whether additional regulatory action is needed. Prescribing Considerations: · Healthcare providers who have patients that are currently on naproxen therapy or are considering naproxen therapy for their patients, should carefully weigh the risks and benefits and use the product according to the label. · For over-the-counter products containing naproxen, healthcare providers should advise their patients to adhere to the recommended daily dose as follows:-1 tablet (220 mg) every 8 to 12 hours while symptoms last-2 tablets (440 mg) may be taken initially within the first hour of symptoms-Patients should not exceed 2 tablets (440 mg) in any 8 to 12 hour period and should not exceed 3 tablets (660 mg) in a 24-hour period. · For prescription use, naproxen should always be prescribed within the recommended ...

... Information for Healthcare Professionals Naproxen Prescribing Considerations: · Healthcare providers who have patients that are currently on naproxen therapy or are considering naproxen therapy for their patients, should carefully weigh the risks and benefits and use the product according to the label. · For over-the-counter products containing naproxen, healthcare providers should advise their patients to adhere to the recommended daily dose as follows:-1 tablet (220 mg) every 8 to 12 hours while symptoms last-2 tablets (440 mg) may be taken initially within the first hour of symptoms-Patients should not exceed 2 tablets (440 mg) in any 8 to 12 hour period and should not exceed 3 tablets (660 mg) in a 24-hour period. · For prescription use, naproxen should always be prescribed within the recommended dosing range of 250 mg to 500 mg twice a day. Data Summary: A clinical trial, Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) was designed to assess whether the non-steroidal anti-inflammatory drugs (NSAIDs)-naproxen and celecoxib (COX-2 inhibitor) had potential benefit in preventing the ...

... than non-selective NSAIDs. 1 A list of the non-selective NSAIDs is available on http :// www.fda.gov / cder / drug / infopage / cox2 / default.htm. 2 The degree of COX-2 selectivity for any given drug has not been definitively established, and there is considerable overlap in in-vitro COX-2 selectivity between agents that have been generally considered to be COX-2 selective (e.g, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib) and older NSAIDs that have been considered to be non-selective (e.g, diclofenac, ibuprofen, naproxen). For purposes of simplicity of discussion and comparisons, this document maintains the traditional separation between COX-2 selective and non-selective agents, but our use of this nomenclature should not be considered as FDA endorsement of such designations. 1 · Long-term placebo-controlled clinical trial data are not available to adequately assess the potential for the non-selective NSAIDs to increase the risk of serious adverse CV events. · Pending the availability of additional long-term controlled clinical trial data, the available data are best interpreted as being consistent with a class effect of an increased risk of serious ...

... than non-selective NSAIDs. 1 A list of the non-selective NSAIDs is available on http :// www.fda.gov / cder / drug / infopage / cox2 / default.htm. 2 The degree of COX-2 selectivity for any given drug has not been definitively established, and there is considerable overlap in in-vitro COX-2 selectivity between agents that have been generally considered to be COX-2 selective (e.g, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib) and older NSAIDs that have been considered to be non-selective (e.g, diclofenac, ibuprofen, naproxen). For purposes of simplicity of discussion and comparisons, this document maintains the traditional separation between COX-2 selective and non-selective agents, but our use of this nomenclature should not be considered as FDA endorsement of such designations. 1 · Long-term placebo-controlled clinical trial data are not available to adequately assess the potential for the non-selective NSAIDs to increase the risk of serious adverse CV events. · Pending the availability of additional long-term controlled clinical trial data, the available data are best interpreted as being consistent with a class effect of an increased risk of serious ...

... Background Ibuprofen has been marketed in the United States as an anti-inflammatory, analgesic, and antipyretic drug for decades. It is widely available in a variety of strengths and formulations for children and adults as single-ingredient over-the-counter (OTC) and prescription products, and can also be found in combination OTC and prescription products. Chemically, ibuprofen is a propionic acid derivative and a member of the class of non-steroidal anti-inflammatory drugs (NSAIDs). The NSAIDs include aspirin, and several other classes of organic acids, including the propionic acid derivatives naproxen and ketoprofen, acetic acid derivatives diclofenac and indomethacin, and the enolic acid piroxicam, and newer agents such as celecoxib. How does ibuprofen work and why does it interact with aspirin? All NSAIDs work by inhibiting the enzyme cyclooxygenase (COX). Aspirin inhibits COX irreversibly, while all non-aspirin NSAIDs are reversible inhibitors of COX. There are two forms of cyclooxygenase; namely, COX-1 found in blood vessels, stomach and kidney, and COX-2, which is induced in settings of inflammation by cytokines and inflammatory mediators. A putative COX-3 has ...

... PhD, Gerald Levy, MD, Stanford Shoor, MD Vanderbilt University School of Medicine: Wayne A. Ray, PhD 2 Background Cyclooxygenase-2 (COX-2) selective nonsteroidal antiinflammatory drugs (NSAIDs) are prescribed for the treatment of arthritis and other musculoskeletal complaints because of their reduced gastrointestinal toxicity compared with traditional, non-selective NSAIDs.1, 2 Questions about cardiovascular risk with these newer agents were raised by the finding of a 4-fold difference in incidence of acute myocardial infarction (AMI) between patients treated with rofecoxib 50 mg / day compared to naproxen 1000 mg / day in a large randomized clinical trial.2 Given the high utilization of COX-2 agents in the US, even a small difference in cardiovascular risk between members of this class would have substantial public health impact. A series of observational studies have examined the questions of cardiovascular risk with rofecoxib and potential cardioprotection with naproxen. A cohort study found nearly a 2-fold increased risk of serious coronary heart disease (AMI and sudden cardiac death (SCD )) among users of high-dose rofecoxib (> 25 mg / day) compared to non-users.3 Another cohort study found ...

... Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21-926 NDA APPROVAL POZEN, Inc. Attention: Paul A. Ossi Sr. Vice President, Regulatory Affairs 1414 Raleigh Road, Suite 400 Chapel Hill, NC 27517 Dear Mr. Ossi: Please refer to your new drug application (NDA) dated August 5, 2005, received August 8, 2005, submitted pursuant to section 505 (b )( 2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for TreximetTM (sumatriptan and naproxen sodium) Tablets. Each tablet contains sumatriptan (85 mg as the succinate) and naproxen sodium (500 mg). We acknowledge receipt of your submissions dated October 11, 2007, January 11, 2008, January 14, 2008, and April 7, 2008. Your October 11, 2007 submission constituted a complete response to our June 8, 2006 action letter. This new drug application provides for the use of TreximetTM (sumatriptan and naproxen sodium) Tablets for the acute treatment of migraine attacks with or without aura in adults. ...

... NIH Office of the Director (OD) National Institute on Aging (NIA) FOR IMMEDIATE RELEASE Monday, December 20, 2004 Subscribe CONTACTS: John Burklow, Don Ralbovsky, NIH Office of Communications and Public Liaison 301-496-5787 Use of Non-Steroidal Anti-Inflammatory Drugs Suspended in Large Alzheimer ' s Disease Prevention Trial The National Institutes of Health (NIH) announced today that research investigators suspended, until further notice, the use of two drugs, naproxen (220 mg twice a day) and celecoxib (200 mg twice a day ), in a large, three-arm, national Alzheimer ’ s disease prevention trial sponsored by the National Institute on Aging (NIA ), a part of the NIH. The trial, called the Alzheimer ’ s Disease Anti-Inflammatory Prevention Trial (or ADAPT) was designed to assess the potential benefit of long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) naproxen (Aleve ™) and the COX-2 inhibitor celecoxib (Celebrex ™) in decreasing the risk of developing Alzheimer ’ s Disease in people 70 years of age or older who were considered to be at increased risk because ...