AUDIENCE: Consumer, Patient, Health Professional, Pharmacy
ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.
For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.
For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels, available at: http://bit.ly/2Uadlbz. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.
- are a class of medicines available by prescription and OTC. They are some of the most commonly used medicines for pain and fever.
- are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.
- work by blocking the production of certain chemicals in the body that cause inflammation.
- are available alone and combined with other medicines. Examples of NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib.
Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
- If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.
- Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels, available at: http://bit.ly/2Uadlbz, to find out if the medicines contain NSAIDs.
- Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.
- Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.
Health Care Professionals
- FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
- These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
- Oligohydramnios is often, but not always, reversible with treatment discontinuation.
- Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
- If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.
- The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.
- Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as naproxen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as naproxen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take naproxen right before or right after the surgery.
NSAIDs such as naproxen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or who drink three or more alcoholic drinks per day while taking naproxen. Tell your doctor if you take any of the following medications: anticoagulants (''blood thinners'') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking naproxen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to naproxen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prescription naproxen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Why is this medication prescribed?
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
How should this medicine be used?
Prescription naproxen comes as a regular tablet, a delayed-release (a tablet that releases the medication in the intestine to prevent damage to the stomach) tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth. The extended-release tablets are usually taken once a day. The tablets, delayed-release tablets, and suspension are usually taken twice a day for arthritis. The tablets and suspension are usually taken every 8 hours for gout, and every 6 to 8 hours as needed for pain. If you are taking naproxen on a regular basis, you should take it at the same time(s) every day.
Nonprescription naproxen comes as tablet and a gelatin coated tablet to take by mouth. It is usually taken with a full glass of water every 8 to 12 hours as needed. Nonprescription naproxen may be taken with food or milk to prevent nausea.
Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take naproxen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the package.
Shake the liquid well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the liquid.
Swallow the delayed-release tablets and extended release tablets whole; do not split, chew, or crush them.
If you are taking naproxen to relieve the symptoms of arthritis, your symptoms may begin to improve within 1 week. It may take 2 weeks or longer for you to feel the full benefit of the medication.
Stop taking nonprescription naproxen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts for more than 3 days.
Other uses for this medicine
Naproxen is also sometimes used to treat Paget's disease of bone (a condition in which the bones become abnormally thick, fragile, and misshapen) and Bartter syndrome (a condition in which the body does not absorb enough potassium, causing muscle cramping and weakness and other symptoms). Talk to your doctor about the risks of using this medication for your condition.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking naproxen,
- tell your doctor and pharmacist if you are allergic to naproxen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen, any medications for pain or fever, other medications, or any of the ingredients in naproxen products. Ask your doctor or pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran); cholestyramine (Prevalite); diuretics ('water pills'); lithium (Lithobid), medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall); probenecid (Probalan; Col-Probenecid); and sulfa medications such as sulfamethoxazole (in Bactrim, in Septra). If you are taking the delayed-release tablets, also tell your doctor if you are taking antacids or sucralfate (Carafate). Your doctor may need to change the doses of your medication or monitor you more carefully for side effects.
- do not take nonprescription naproxen with any other medication for pain unless your doctor tells you that you should.
- tell your doctor if you have been told to follow a low sodium diet and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; anemia (red blood cells do not bring enough oxygen to all parts of the body); or liver or kidney disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breastfeeding. If you become pregnant while taking naproxen, call your doctor.
- talk to your doctor about the risks and benefits of taking naproxen if you are 65 years of age or older. Older adults should usually take lower doses of naproxen for short periods of time because higher doses used regularly may not be more effective and are more likely to cause serious side effects.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking naproxen.
- you should know that this medication may make you dizzy, drowsy, or depressed. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Naproxen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- excessive thirst
- difficulty falling asleep or staying asleep
- burning or tingling in the arms or legs
- cold symptoms
- ringing in the ears
- hearing problems
Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more naproxen until you speak to your doctor:
- changes in vision
- feeling that the tablet is stuck in your throat
- unexplained weight gain
- shortness of breath or difficulty breathing
- swelling in the abdomen, ankles, feet, or legs
- sore throat, fever, chills, and other signs of infection
- skin reddening
- swelling of the eyes, face, lips, tongue, throat, arms, or hands
- difficulty breathing or swallowing
- excessive tiredness
- pain in the upper right part of the stomach
- yellowing of the skin or eyes
- flu-like symptoms
- bruises or purple blotches under the skin
- fast heartbeat
- cloudy, discolored, or bloody urine
- back pain
- difficult or painful urination
- decreased urination
- loss of appetite
Naproxen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
- extreme tiredness
- stomach pain
- slow or difficult breathing
What other information should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking naproxen.
If you are taking prescription naproxen, do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
- Anaprox® DS
Brand names of combination products
- Aleve PM® (containing Diphenhydramine, Naproxen)
- Treximet® (containing Naproxen, Sumatriptan)
- Vimovo® (containing Esomeprazole, Naproxen)