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 use nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as transdermal diclofenac may have a higher risk of having a heart attack or a stroke than people who do not use these medications. These events may happen without warning and may cause death. The risk may be higher for people who use NSAIDs for a long time. Do not use an NSAID such as transdermal diclofenac 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 your body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not use transdermal diclofenac right before or right after the surgery.
NSAIDs such as transdermal diclofenac may cause swelling, ulcers, bleeding, or holes in the stomach or intestines. 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 use NSAIDs for a long time, are older in age, have poor health, smoke, or drink alcohol while using transdermal diclofenac . Tell your doctor if you have any of these risk factors and if you have or have ever had ulcersor bleeding in your stomach or intestines, or other bleeding disorders. 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) or naproxen (Aleve, Naprosyn); 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). If you experience any of the following symptoms, stop using transdermal diclofenac and call your doctor: stomach pain, heartburn, vomiting a substance 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 take your blood pressure and order certain tests to check your body's response to transdermal diclofenac. Be sure to tell your doctor how you are feeling so that the 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 transdermal diclofenac 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) to obtain the Medication Guide.
Why is this medication prescribed?
Transdermal diclofenac is used to treat short-term pain due to minor strains, sprains, and bruises in adults and children 6 years of age and older. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain.
How should this medicine be used?
Transdermal diclofenac comes as a patch to apply to the skin. Diclofenac patches are usually applied two times a day, once every 12 hours. Apply diclofenac patches at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not apply more or fewer patches or apply patches more often than prescribed by your doctor.
Do not apply diclofenac patches to skin that is broken, damaged, cut, infected, or covered by a rash.
Do not let the patches come in contact with your eyes, nose, or mouth. If the patch does touch your eye, wash the eye out immediately with water or saline. Call a doctor if there is eye irritation that lasts for more than one hour.
Do not wear a patch while bathing or showering. Plan to bathe or shower after you remove a patch and before you apply the next patch.
To apply diclofenac patches, follow these steps:
- Wash the skin area where you will apply the patch with soap and water. Do not use any moisturizing soaps, lotions, astringents, or other skin care products on the chosen skin area.
- Completely dry the skin area where you will be applying the patch.
- Cut open the envelope containing the patches, cutting on the dotted line and making sure not to cut the zipper seal just below it.
- Pull apart the zipper seal on the envelope and remove one patch. Reseal the envelope by squeezing the zipper seal together. Make sure the envelope is closed tightly to keep the patches inside from drying out.
- Fold over one corner of the patch and gently rub the folded corner between your finger and thumb to separate the patch from the clear liner that is attached to the sticky side. Peel off the entire liner.
- Firmly press the patch into place on the chosen skin area. Press down around all four edges to secure the patch.
- The patch may begin to peel off while you are wearing it. If this happens, tape down the edges of the patch with first aid tape.
- When you remove a patch, fold it in half so that it sticks to itself and throw it away in a garbage can that is out of the reach of children and pets.
- Wash your hands when you are finished applying or handling the patch.
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 diclofenac patches,
- tell your doctor and pharmacist if you are allergic to diclofenac (Cambia, Pennsaid, Solaraze, Voltaren, Zipsor, Zorvolex, in Arthrotec), aspirin, or other NSAIDs; any other medications; or any of the other ingredients in diclofenac patches. Ask your pharmacist or check the Medication Guide for a list of the ingredients. Tell your doctor and pharmacist if you have asthma, growths in your nose, or an ongoing runny nose and if you have had an asthma attack, hives, difficulty breathing or swallowing, or an allergic reaction after taking aspirin, an aspirin-containing product, or any other NSAID medication. Your doctor will probably tell you not to use diclofenac patches.
- 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: acetaminophen (Tylenol, other products); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc, in Uniretic); perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as 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); certain antibiotics; 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); cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); lithium (Lithobid); medications for seizures; and methotrexate (Otrexup, Rasuvo, Trexall). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have severe diarrhea or vomiting or think you may be dehydrated, if you drink or have a history of drinking large amounts of alcohol, and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, heart failure; swelling of the hands, feet, ankles, or lower legs; or kidney or liver 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 breast-feeding. If you become pregnant while using diclofenac patches, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using diclofenac patches.
- you should know that during treatment with diclofenac patches it may be harder to know if you have an infection or illness because this medication may also lower or prevent fever. Call your doctor if you are not feeling well or have other signs of an infection or illness.
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?
Apply a new patch as soon as you remember it. However, if it is almost time for the next scheduled application, skip the missed dose and continue your regular schedule. Do not apply an extra diclofenac patch to make up for a missed dose.
What side effects can this medication cause?
Transdermal diclofenac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dryness, redness, itching, swelling, irritation, or numbness at application site
- changes in taste
- tingling skin
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- difficulty swallowing
- swelling of the face or throat, arms, or hands
- unexplained weight gain
- shortness of breath or difficulty breathing
- swelling in the abdomen, ankles, feet, or legs
- worsening of asthma
- yellowing of the skin or eyes
- extreme tiredness
- unusual bleeding or bruising
- lack of energy
- loss of appetite
- pain in the upper right part of the stomach
- flu-like symptoms
- dark-colored urine
- blisters on skin
- pale skin
- fast heartbeat
Diclofenac patches 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).
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 and pets. Store it at room temperature.
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
If someone swallows, chews, or sucks on diclofenac patches, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Do not let anyone else use 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.
- Flector® Patch