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 topical diclofenac (Pennsaid, Voltaren) 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. This risk may be higher for people who use NSAIDs for a long time. Do not use an NSAID such as topical 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 topical diclofenac (Pennsaid, Voltaren) right before or right after the surgery.
NSAIDs such as topical diclofenac (Pennsaid, Voltaren) may cause swelling, 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 use NSAIDs for a long time, are 60 years of age or older, have poor health, smoke, or drink alcohol while using topical diclofenac. Tell your doctor if you have any of these risk factors and if you have or have ever had ulcers or 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 topical 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 topical diclofenac (Pennsaid, Voltaren). 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 prescription topical 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?
Nonprescription (over-the-counter) diclofenac topical gel (Voltaren Arthritis Pain) is used to relieve pain from arthritis in certain joints such as those of the knees, ankles, feet, elbows, wrists, and hands. Prescription diclofenac topical solution (Pennsaid) is used to relieve osteoarthritis pain in the knees. 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.
Diclofenac is also available as a 3% gel (Solaraze; generic) that is applied to the skin to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). This monograph only gives information about nonprescription diclofenac topical gel (Voltaren Arthritis Pain) for arthritis and prescription topical solution (Pennsaid) for osteoarthritis of the knee. If you are using diclofenac gel (Solaraze, generic) for actinic keratosis, read the monograph entitled diclofenac topical (actinic keratosis).
How should this medicine be used?
Prescription topical diclofenac comes as a 1.5% topical solution (liquid) to apply to the knee 4 times a day and as a 2% topical solution (Pennsaid) to apply to the knee 2 times a day. Nonprescription (over the counter) topical diclofenac comes as a 1% gel (Voltaren Arthritis Pain) to apply to up to 2 body areas (e.g., 1 knee and 1 ankle, 2 knees, 1 foot and 1 ankle, or 2 hands) 4 times daily for up to 21 days or as recommended by your doctor. Apply diclofenac gel (Voltaren Arthritis Pain) or topical solution (Pennsaid) at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use topical diclofenac (Pennsaid, Voltaren Arthritis Pain) exactly as directed. Do not use more or less of it or use it more often or for a longer period of time than prescribed by your doctor. Do not apply the gel or topical solution to any area of your body that your doctor did not tell you to treat.
Apply diclofenac gel (Voltaren Arthritis Pain) or topical solution (Pennsaid) to clean, dry skin. Do not apply the medication to skin that is broken, peeling, infected, swollen, or covered with a rash.
Diclofenac gel (Voltaren Arthritis Pain) and topical solution (Pennsaid) are only for use on the skin. Be careful not to get the medication in your eyes, nose, or mouth. If you do get the medication in your eyes, rinse your eyes with plenty of water or saline. If your eye(s) are still irritated after one hour, call your doctor.
After you apply diclofenac gel (Voltaren Arthritis Pain) or topical solution (Pennsaid), you should not cover the treated area with any type of dressing or bandage and you should not apply heat to the area. You should not shower or bathe for at least 30 minutes after you apply the topical solution (Pennsaid) and for at least 1 hour after you apply the gel (Voltaren Arthritis Pain). Do not cover the treated area with clothes or gloves for 10 minutes after you apply the gel (Voltaren Arthritis Pain), or until the topical solution (Pennsaid) has dried if you are using the topical solution.
It may take up to 7 days before you feel the full benefit from nonprescription topical diclofenac gel (Voltaren Arthritis Pain). If you do not feel arthritis pain relief from this product after 7 days of use, stop use and contact your doctor.
To use topical diclofenac gel (Voltaren Arthritis Pain), follow these steps:
- Before you use a new tube of diclofenac gel (Voltaren Arthritis Pain) for the first time, open the safety seal that covers the tube and then puncture the opening of the tube using the spiked top of the cap. Do not open the seal with scissors or sharp objects.
- Place one of the dosing cards from the package on a flat surface so that you can read the print.
- Using the lines on the dosing card as a guide, squeeze the correct amount of gel onto the dosing card evenly. Make sure the gel covers the entire area marked for your correct dose depending if it is for the upper (hand, wrist, elbow) or lower (foot, ankle, knee) body. Put the cap back on the tube.
- Clean and dry the skin area where you will apply the medication. Do not apply to skin that has any cuts, open wounds, infections or rashes.
- Apply the gel to the directed skin areas, using the dosing card to help apply the gel to the skin to up to 2 body areas. Do not apply to more than 2 body areas. Use your hands to gently rub the gel into the skin. Make sure to cover the entire affected area with the gel. Do not apply in same area as any other product.
- Hold the end of the dosing card with your fingertips, and rinse and dry the card. Store the dosing card until next use, out of reach of children. Do not share the dosing card with another person.
- Wash your hands well after you apply the gel, unless you are treating your hands. If you are treating your hands, do not wash them for at least one hour after you apply the gel.
To use topical diclofenac 1.5 % topical solution, follow these steps:
- Clean and dry the skin area where you will apply the medication.
- Apply the topical solution to your knee 10 drops at a time. You can do this by dropping the topical solution directly onto the knee or by first dropping it onto the palm of your hand and then spreading it onto the knee.
- Use your hand to evenly spread the topical solution around the front, back, and sides of the knee.
- Repeat this step until 40 drops of topical solution have been applied and the knee is completely covered with the topical solution.
- If your doctor has told you to apply the topical solution to both knees, repeat steps 2 to 4 to apply the medication to your other knee.
- Wash and dry your hands well after you apply the topical solution. Avoid skin contact with other people and the treated knee area.
To use topical diclofenac 2% topical solution (Pennsaid), follow these steps:
- You will need to prime the pump that contains this medication before you use it for the first time. Remove the cap from the pump and hold the pump upright. Press down the top of the pump four times and catch any medication that comes out on a paper towel or tissue. Throw away the paper towel or tissue in a trash can.
- When you are ready to apply your medication, wash your hands well with soap and water.
- Hold the pump at an angle and press down the top of the pump to dispense the medication onto your palm. Press down the top a second time to dispense another pump of medication onto your palm.
- Use your palm to apply the medication evenly to the front, back, and sides of your knee.
- If your doctor told you to apply the medication to both knees, repeat steps 3-4 to apply the medication to your other knee.
- Wash your hands well with soap and water as soon as you finish applying the medication.
- Replace the cap on your pump and store the pump upright.
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 topical diclofenac,
- tell your doctor and pharmacist if you are allergic to diclofenac (Cambia, Flector, Voltaren Arthritis Pain, Solaraze, Zipsor, Zorvolex, in Arthrotec), aspirin, or other NSAIDs; any other medications; or any of the ingredients in topical diclofenac preparations. Ask your pharmacist or check the Medication Guide 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: acetaminophen (Tylenol, in other products); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, Zestril, in Prinzide and 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); digoxin (Lanoxin); diuretics ('water pills'); lithium (Lithobid); medications for seizures,methotrexate (Otrexup, Rasuvo, Trexall) or pemetrexed (Alimta). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- you should know that you should not apply sunscreens, cosmetics, lotions, moisturizers, insect repellents, or other topical medications to areas treated with topical diclofenac. If you have been prescribed diclofenac topical solution (Pennsaid), wait until the area of application is completely dry before applying any of these products or other substances.
- 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 or asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); swelling of the hands, feet, ankles, or lower legs; heart failure; or kidney or liver disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, plan to become pregnant, or if you are breastfeeding. If you become pregnant while using diclofenac gel or topical solution, call your doctor.
- you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of using topical diclofenac.
- plan to avoid unnecessary or prolonged exposure to real or artificial sunlight (tanning beds or lamps, ultraviolet light) and to wear protective clothing to cover areas treated with topical diclofenac. Topical diclofenac may make your skin sensitive to sunlight.
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 the missed dose as soon as you remember it. However, if it is almost time for your next scheduled application, skip the missed dose and continue your regular dosing schedule. Do not apply extra diclofenac gel (Voltaren Arthritis Pain) or topical solution (Pennsaid) to make up for a missed dose.
What side effects can this medication cause?
Topical diclofenac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dryness, redness, itching, swelling, pain, hardness, irritation, swelling, scaling, or numbness at application site
- stomach pain
- numbness, burning, or tingling in the hands, arms, feet, or legs
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, 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
- excessive tiredness
Topical diclofenac 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. Store it at room temperature and keep it from freezing or excess heat.
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
If someone swallows topical diclofenac, 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.
Symptoms of overdose may include the following:
- lack of energy
- stomach pain
- bloody, black, or tarry stools
- vomiting a substance that is bloody or looks like coffee grounds
- slow, shallow, or irregular breathing
- difficulty breathing or swallowing
- loss of consciousness
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.
- Voltaren Arthritis Pain®