Safety Alerts & Recalls

What does this mean?

For many patients, the benefits of diclofenac will continue to outweigh the small risk of liver toxicity. However, if you take a diclofenac product you should be aware of the warning signs and symptoms of liver toxicity, including nausea, fatigue, tiredness, diarrhea, itching, jaundice (yellowing of the skin or whites of the eyes), pain or tenderness in your right side, and "flu-like" symptoms. Please seek medical attention as soon as possible if any of these symptoms occur.

For those individuals who are not experiencing side effects, you may want to follow up with your physician at your next visit to discuss your liver function and evaluate your other risk factors for liver toxicity, including use of alcohol or other medications that may be toxic to the liver. The possible risk for adverse liver related events from taking diclofenac may be minimized by using the lowest dose to treat your pain for the shortest duration possible.

If you have any questions or concerns about the update to the prescribing information for diclofenac products or if you think you are experiencing side effects, please follow up with your doctor.

Safety Update to the Prescribing Information for Diclofenac Products

The FDA has required revisions to the prescribing information for diclofenac to add new warnings about the potential for increases in liver enzymes during treatment. There have been post-marketing reports of cases of drug-induced liver toxicity reported in the first month of use of diclofenac. Increased liver enzymes can be an early sign of liver toxicity. The prescribing information is being updated for all products containing diclofenac, including capsules, gels, patches, solutions, and tablets.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Diclofenac is also used to treat painful menstrual periods and pain from other causes. Diclofenac is sold under the names Cambia, Cataflam, Flector Solaraze, Voltaren, Voltaren-XR, ZIpsor, and as a combination product called Arthrotec (containing diclofenac and misoprostol).

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-12-08
Last Updated: 2009-12-08

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