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.
Ketorolac injection is used for the short-term relief of moderately severe pain in people who are at least 17 years of age. Ketorolac injection should not be used for longer than 5 days, for mild pain, or for pain from chronic (long-term) conditions. You will receive your first doses of ketorolac by intravenous (into a vein) or intramuscular (into a muscle) injection in a hospital or medical office. After that, your doctor may choose to continue your treatment with oral ketorolac. You must stop taking oral ketorolac and using ketorolac injection on the fifth day after you received your first dose of ketorolac injection. Talk to your doctor if you still have pain after 5 days or if your pain is not controlled with this medication. Ketorolac may cause serious side effects.
People who are treated with nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as ketorolac may have a higher risk of having a heart attack or a stroke than people who are not treated with these medications. These events may happen without warning and may cause death. This risk may be higher for people who are treated with NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke or 'ministroke;' and if you have or have ever had high blood pressure. 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.
Receiving ketorolac injection increases the risk that you will experience severe or uncontrolled bleeding. Tell your doctor if you have or have ever had a bleeding or clotting problem. Your doctor will probably not give you ketorolac injection.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are using ketorolac injection. If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not use ketorolac injection right before or right after the surgery.
NSAIDs such as ketorolac 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, smoke cigarettes, or drink alcohol while using ketorolac injection. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; or oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Deltasone). Do not take aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) while you are using ketorolac. Also tell your doctor if you have or have ever had ulcers, holes, or bleeding in your stomach or intestine, or a disease that causes inflammation of the bowels such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum). If you experience any of the following symptoms, stop using ketorolac injection 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.
Ketorolac may cause kidney failure. Tell your doctor if you have kidney or liver disease, if you have had severe vomiting or diarrhea or think you may be dehydrated, and if you are taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); or diuretics ('water pills'). If you experience any of the following symptoms, stop using ketorolac injection and call your doctor: unexplained weight gain; swelling of the hands, arms, feet, ankles, or lower legs; confusion; or seizures.
Some people have severe allergic reactions to ketorolac injection. Tell your doctor if you are allergic to ketorolac, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn), any other medications, or any of the ingredients in ketorolac injection. Also tell your doctor if you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose). If you experience any of the following symptoms, stop using ketorolac injection and call your doctor right away: rash; fever; peeling or blistering skin; hives; itching; swelling of the eyes, face, throat, tongue, lips; difficulty breathing or swallowing; or hoarseness.
You should not receive ketorolac injection during labor or while you are giving birth.
Do not breast-feed while you are using ketorolac injection.
Tell your doctor if you are 65 years of age or older or if you weigh less than 110 lb (50 kg). Your doctor will need to prescribe a lower dose of medication. If you are an older adult, you should know that ketorolac injection is not as safe as other medications that can be used to treat your condition. Your doctor may choose to prescribe a different medication that is safer for use in older adults.
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 ketorolac injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) each time you receive a dose of ketorolac injection . 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) to obtain the Medication Guide.
Why is this medication prescribed?
Ketorolac is used to relieve moderately severe pain in adults, usually after surgery. Ketorolac 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?
Ketorolac injection comes as a solution (liquid) to inject intramuscularly (into a muscle) or intravenously (into a vein). It is usually given every 6 hours on a schedule or as needed for pain by a healthcare provider in a hospital or medical office.
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 using ketorolac injection,
- tell your doctor if you are taking probenecid (Probalan) or pentoxifylline (Pentoxil, Trental). Your doctor will probably tell you not to use ketorolac injection if you are taking either of these medications.
- 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 the medications listed in the IMPORTANT WARNING section and any of the following: alprazolam (Niravam, Xanax); angiotensin II receptor antagonists such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor), telmisartan (Micardis), or valsartan (Diovan, in Exforge); lithium (Lithobid); medications for seizures such as carbamazepine (Equetro, Tegretol) or phenytoin (Dilantin); methotrexate (Otrexup, Rheumatrex, Trexall); muscle relaxants; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax, others), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), and sertraline (Zoloft); or thiothixene (Navane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any medical condition, especially the conditions mentioned in the IMPORTANT WARNING section.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or you plan to become pregnant. If you become pregnant while using ketorolac injection, call your doctor.
- you should know that your blood pressure may increase during treatment with ketorolac injection. Your doctor will probably monitor your blood pressure during your treatment.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
Ketorolac injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- sores in the mouth
- ringing in the ears
- pain at injection site
- small red or purple dots on the skin
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using ketorolac injection and call your doctor immediately:
- yellowing of the skin or eyes
- excessive tiredness
- unusual bleeding or bruising
- lack of energy
- loss of appetite
- pain in the upper right part of the stomach
- flu-like symptoms
- pale skin
- fast heartbeat
Ketorolac injection may cause other side effects. Call your doctor if you have any unusual problems while using 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).
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:
- stomach pain
- bloody, black, or tarry stools
- vomit that is bloody or looks like coffee grounds
- difficulty swallowing
- difficulty breathing, slowed breathing or fast, shallow breathing
- coma (loss of consciousness for a period of time)
What other information should I know?
Ask your pharmacist any questions you have about ketorolac injection.
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.
¶ This branded product is no longer on the market. Generic alternatives may be available.