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.
Why is this medication prescribed?
The combination of aspirin and extended-release dipyridamole is in a class of drugs called antiplatelet agents. It works by preventing excessive blood clotting. It is used to reduce the risk of stroke in patients who have had or are at risk of stroke.
How should this medicine be used?
The combination of aspirin and extended-release dipyridamole comes as a capsule to take by mouth. It is usually taken twice a day, one capsule in the morning and one in the evening. Aspirin and extended-release dipyridamole should be swallowed whole. Do not open, crush, break, or chew the capsules.
Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aspirin and extended-release dipyridamole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
The combination of aspirin and extended-release dipyridamole decreases the risk of having a stroke but does not eliminate that risk. Continue to take aspirin and extended-release dipyridamole even if you feel well. Do not stop taking aspirin and extended-release dipyridamole without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking aspirin and extended-release dipyridamole,
- tell your doctor and pharmacist if you are allergic to aspirin, celecoxib (Celebrex), choline salicylate (Arthropan), diclofenac (Cataflam), diflunisal (Dolobid), dipyridamole (Persantine), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin, Nuprin), indomethacin (Indocin), ketoprofen (Orudis, Oruvail), ketorolac (Toradol), magnesium salicylate (Nuprin Backache, Doan's), meclofenamate, mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), oxaprozin (Daypro), piroxicam (Feldene), rofecoxib (Vioxx) (no longer available in the US), sulindac (Clinoril), tolmetin (Tolectin), or any other drugs.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); ambenonium (Mytelase); angiotensin-converting enzyme inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants ('blood thinners') such as warfarin (Coumadin) and heparin; beta-blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne), metoprolol (Lopressor), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal), sotalol (Betapace), and timolol (Blocadren); diabetes medications such as acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (DiaBeta, Micronase, Glynase), repaglinide (Prandin), tolazamide (Tolinase), and tolbutamide (Orinase); diuretics ('water pills') such as amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Hydrodiuril), indapamide (Lozol), metolazone (Zaroxolyn), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium); methotrexate (Folex, Mexate, Rheumatrex); neostigmine (Prostigmin); nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib (Celebrex), choline salicylate (Arthropan), diclofenac (Cataflam), diflunisal (Dolobid), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin, Nuprin, others), indomethacin (Indocin), ketoprofen (Orudis, Oruvail), ketorolac (Toradol), magnesium salicylate (Nuprin Backache, Doan's), meclofenamate, mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), and tolmetin (Tolectin); phenytoin (Dilantin); probenecid (Benemid); pyridostigmine (Mestinon); sulfinpyrazone (Anturane); and valproic acid and related drugs (Depakene, Depakote).
- tell your doctor if you have or have ever had liver, kidney, or heart disease; a recent heart attack; bleeding disorders; low blood pressure; vitamin K deficiency; ulcers; the syndrome of asthma, rhinitis, and nasal polyps; or if you drink three or more alcoholic drinks a day.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using aspirin and extended-release dipyridamole, call your doctor immediately.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin and extended-release dipyridamole. Your doctor may tell you to stop taking aspirin and extended-release dipyridamole before surgery.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet while taking aspirin and extended-release dipyridamole.
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?
Side effects from aspirin and extended-release dipyridamole can occur. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- muscle and joint pain
If you experience any of the following symptoms, call your doctor immediately:
- severe rash
- swelling of the lips, tongue, or mouth
- difficulty breathing
- warm feeling
- chest pain
- rapid heartbeat
- ringing in the ears
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).
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
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.
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.
What other information should I know?
Do not substitute the individual components of aspirin and dipyridamole (Persantine) for the combination product of aspirin and extended-release dipyridamole.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to aspirin and extended-release dipyridamole.
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.
Brand names of combination products
- Aggrenox® (containing Aspirin, Dipyridamole)