FDA Alert [12/23/04]: Based on emerging information, the risk of cardiovascular and cerebrovascular events may increase among patients taking naproxen. FDA recommends patients not exceed the recommended dose. For more information about these risks, refer to the FDA Alert for Healthcare Providers.

What Is Naproxen?
Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used as a pain reliever/fever reducer.
It is available over the counter for:
• Headache
• Minor pain of arthritis
• Backaches
• Menstrual cramps
• Muscular aches
• Toothaches
• The common cold
• Temporary reducing fever
And by prescription for:
• Relief of symptoms of osteoarthritis (the arthritis caused by age-related wear and tear on bones and joints), rheumatoid
arthritis in adults, and juvenile arthritis
• Relief of signs and symptoms of ankylosing spondylitis
• Reducing swelling and relieving pain caused by gout
• Relieving the signs and symptoms of tendonitis and bursitis Who Should Not Take Naproxen?
Do not take naproxen if you:
• Ever had asthma, rhinitis, or nasal polyps after taking aspirin or other NSAID medicines. Aspirin-sensitive patients should not take naproxen as reactions have the potential of causing
death.
• Have advanced kidney disease
• Are pregnant, especially your last 3 months. What Should I Do Before Taking Naproxen? Ask a doctor or pharmacist before using naproxen if you:
• Are trying to get pregnant, are pregnant, or are breast-feeding
• Have or had angina (chest pain), heart attack, or blocked artery in your heart
• Have kidney problems
• Have liver problems
• Have heart failure
• Have high blood pressure
• Retain fluids (hold extra body water and swell)
• Had an allergic reaction to aspirin or other NSAID medicines
• Had a serious stomach problem in the past
• Have or had any other medical problems or allergies

Does Naproxen Interact with other Drugs or Food?
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider may have to
adjust your dose or watch you more closely if you take any of the following medications:
• Certain blood pressure medicines called ACE inhibitors
• Furosemide (Lasix)
• Lithium
• Methotrexate
• Warfarin (coumadin)
• Aspirin
• Other NSAIDs
Are There Other Risks?
Naproxen can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take naproxen and with higher doses of naproxen. Stomach bleeding can also
happen suddenly while you take naproxen. Stop taking naproxen and call your healthcare provider right away if you get:
• A burning stomach pain
• Black bowel movements that look like tar
• Vomit that looks like blood or coffee grounds
Allergic reactions: Naproxen can cause serious allergic reactions, including asthma-like symptoms (problems breathing, swallowing, and wheezing) and rash.
Liver damage: Stop taking naproxen and tell your doctor right away if you have nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, flu-like symptoms, and
dark urine.
Kidney problems: Naproxen can cause serious kidney problems, including sudden kidney failure or worsening of kidney problems that you already have.
Fluid retention: Naproxen can cause fluid retention (holding of water in your body) and swelling. Fluid retention can be a serious problem if you have high blood pressure or heart failure.
Pregnancy: Do not take naproxen during your last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery. Tell your doctor if you are pregnant or planning to become pregnant
Breast-feeding: Tell your doctor if you are breast-feeding.
How Do I Take Naproxen?
When taking an over-the-counter naproxen product, 1 tablet (220 mg) should be taken every 8 to 12 hours while symptoms last. You may take 2 tablets within the first hour of symptoms for the
first dose. However, you should not exceed 2 tablets (440 mg) in any 8 to 12 hour period or 3 tablets (660 mg) in a 24-hour period. If your healthcare provider has prescribed naproxen to you, you
should take it according to their directions.

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
dosing range of 250 mg to 500 mg twice a day.
Data Summary:
The National Institutes of Health (NIH) announced on December 20, 2004, that they were halting a clinical trial in patients at risk of developing Alzheimer's Disease treated with non-steroidal anti-inflammatory drugs due to potential increased cardiovascular events associated with drug therapy. The 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 onset of Alzheimer’s disease. The study enrolled subjects 70 years of age or older who were considered to be at increased risk because of family history, but did not yet have symptoms of the disease. Approximately 2400 volunteer participants were randomly assigned to receive naproxen (220 mg twice a day), celecoxib, or placebo for periods of time up to three years. Although no significant increase in risk for celecoxib was found in this trial, the study was suspended in part because of findings reported last week from a National Cancer Institute (NCI) colon cancer prevention trial that demonstrated increased cardiovascular events related to celecoxib use. In addition, preliminary data from the ADAPT trial indicated an apparent increase in reports of cardiovascular and cerebrovascular adverse events among the participants taking naproxen when compared with those on placebo. We are continuing to analyze these data to determine the validity of these observations.

Date created: December 23, 2004, Updated January 10, 2005