[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for diclofenac (topical) to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
What is this medicine?
DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). The 1% skin gel is used to treat osteoarthritis of the hands or knees. The 3% skin gel is used to treat actinic keratosis.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for external use only. Follow the directions on the prescription label. Wash hands before and after use. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Use your doses at regular intervals. Do not use your medicine more often than directed.
A special MedGuide will be given to you by the pharmacist with each prescription and refill of the 1% gel. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. The 3% gel is not approved for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
aspirin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
Do not use any other skin products without telling your doctor or health care professional.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need to follow up with your health care provider to monitor your progress. You may need to be treated for up to 3 months if you are using the 3% gel, but the full effect may not occur until 1 month after stopping treatment. If you develop a severe skin reaction, contact your doctor or health care professional immediately.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.
This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.
This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store the 1% gel at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Store the 3% gel at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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