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 omeprazole is used to reduce the risk of stroke or heart attack in patients who have had or are at risk of these conditions and are also at risk of developing a stomach ulcer when taking aspirin. Aspirin is in a class of medications called antiplatelet agents. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
How should this medicine be used?
The combination of aspirin and omeprazole comes as a delayed-release tablet (releases the medication in the intestine to prevent damage to the stomach) to take by mouth. It is usually taken once daily with liquid at least 60 minutes before a meal. Take the combination of aspirin and omeprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take the combination of aspirin and omeprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the delayed-release tablets whole; do not split, dissolve, chew, or crush them.
Continue to take aspirin and omeprazole even if you feel well. Do not stop taking aspirin and omeprazole without talking to your doctor. If you stop taking aspirin and omeprazole, there is a higher risk that you may have a heart attack or stroke.
Do not take the combination of aspirin and omeprazole to treat sudden signs and symptoms of a heart attack or stroke.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
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 omeprazole,
- tell your doctor and pharmacist if you are allergic to aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, others) and indomethacin (Indocin), omeprazole, any other medications, or any of the ingredients in the combination of aspirin and omeprazole delayed-release tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking rilpivirine (Edurant, in Complera, in Odefsey). Your doctor will probably tell you not to take aspirin and omeprazole if you are taking this medication.
- 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); anticoagulants ('blood thinners') such as heparin and warfarin (Coumadin, Jantoven); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec), fosinopril, lisinopril (Prinivil, Qbrelis, Zestril), perindopril (Aceon), quinapril (Accupril), and ramipril (Altace); antiretrovirals such as atazanavir (Reyataz, in Evotaz), nelfinavir (Viracept), or saquinavir (Invirase); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, others), nadolol (Corgard, in Corzide), and propranolol (Inderal, Innopran); citalopram (Celexa); cilostazol; clopidogrel (Plavix); cyclosporine (Gengraf, Neoral, Sandimmune); dasatinib (Sprycel); oral medications for diabetes; diazepam (Diastat, Valium); digoxin (Lanoxin); disulfiram (Antabuse); diuretics ('water pills'); erlotinib (Tarceva); iron salts; itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); methotrexate (Otrexup, Rasuvo, Trexall); mycophenolate (Cellcept); nilotinib (Tasigna); other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn); phenytoin (Dilantin, Phenytek); probenecid (Probalan); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); tacrolimus (Astagraf, Prograf); ticagrelor (Brilinta); valproic acid (Depakene); and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John's Wort.
- tell your doctor if you have or have ever had severe shortness of breath, chest tightness or pain, coughing or wheezing (asthma), rhinitis (frequent stuffed or runny nose), or nasal polyps (growths on the linings of the nose) after taking aspirin or other NSAIDs including ibuprofen (Advil, Motrin, others). Your doctor may tell you that you should not take aspirin and omeprazole if you have any of these conditions.
- tell your doctor if you are of Asian descent or if you drink three or more alcoholic drinks every day. Also, tell your doctor if you have or have ever had a low level of magnesium in your blood, bleeding problems such as hemophilia, lupus, or liver or kidney disease.
- you should know that aspirin should not be taken by children and teenagers who have chicken pox, flu, flu symptoms, or who have received the varicella virus (chicken pox) vaccine in the past six weeks because of the risk of Reye's Syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, plan to become pregnant, or are breastfeeding. If you become pregnant while taking an aspirin-containing medication, call your doctor. Aspirin may harm the fetus and cause problems with delivery if it is taken during the last few months of pregnancy.
- you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of taking aspirin and omeprazole.
- if you are 70 years of age or older, do not take this medication for a longer period of time than recommended by your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin and omeprazole.
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?
Aspirin and omeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- unusual bruising or bleeding
- bloody or black, tarry stools
- blood in urine
- bloody vomit
- vomit that looks like coffee grounds
- severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps
- frequent nose bleeds
- changes in urination, swelling of the hands and feet, rash, itching, or having breath that smells like ammonia
- yellowing of the skin or eyes
- dark urine
- pain or discomfort in right upper stomach area
- shortness of breath, lightheadedness, muscle weakness, pale skin, feeling tired, mood changes, or numbness
- seizures, dizziness, muscle aches, or hand or feet spasms
- joint pain
- rash, especially a rash on the cheeks or arms that gets worse in sunlight
People who take proton pump inhibitors such as omeprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. The risk is highest in people who take high doses of one of these medications or take them for one year or longer.
Aspirin and omperazole 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). Your medication may come with a desiccant packet (small packet that contains a substance that absorbs moisture to keep the medication dry) in the container. Leave the packet in the bottle, do not throw it away.
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.
Symptoms of overdose may include:
- ringing in the ears
- blurred vision
- rapid heartbeat
- dry mouth
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment, especially if you have severe diarrhea.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking aspirin and omperazole.
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.