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Voltaren Gel and Liver Damage

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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm196683.htm

Voltaren Gel and Liver Damage

New warnings and precautions regarding the risk of liver damage have been added

to the labeling of Voltaren Gel (diclofenac sodium topical gel) 1% and other

drugs that contain diclofenac sodium. Voltaren Gel is a non-steroidal

anti-inflammatory drug used to relieve pain from osteoarthritis of the joints,

such as the knees and those of the hands.

The risk: Liver damage (hepatotoxicity) has been reported in people in the first

month of using Voltaren Gel, although this damage can occur at any time during

use of the drug. Severe reactions including liver cell death (necrosis),

yellowing of the skin and whites of the eyes (jaundice), hepatitis, and liver

failure have been reported. Some of these cases resulted in death or liver

transplantation.

Recommendations:

Let your health care professional know if you have any liver problems before you

use Voltaren Gel.

Contact your health care professional if after using Voltaren Gel you have side

effects, such as nausea, fatigue, lethargy, diarrhea, itching, jaundice, stomach

tenderness, or flu-like symptoms.

This article appears on FDA's Consumer Updates page, which features the latest

on all FDA-regulated products.

Date Posted: January 12, 2010

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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm196683.htm

Voltaren Gel and Liver Damage

New warnings and precautions regarding the risk of liver damage have been added

to the labeling of Voltaren Gel (diclofenac sodium topical gel) 1% and other

drugs that contain diclofenac sodium. Voltaren Gel is a non-steroidal

anti-inflammatory drug used to relieve pain from osteoarthritis of the joints,

such as the knees and those of the hands.

The risk: Liver damage (hepatotoxicity) has been reported in people in the first

month of using Voltaren Gel, although this damage can occur at any time during

use of the drug. Severe reactions including liver cell death (necrosis),

yellowing of the skin and whites of the eyes (jaundice), hepatitis, and liver

failure have been reported. Some of these cases resulted in death or liver

transplantation.

Recommendations:

Let your health care professional know if you have any liver problems before you

use Voltaren Gel.

Contact your health care professional if after using Voltaren Gel you have side

effects, such as nausea, fatigue, lethargy, diarrhea, itching, jaundice, stomach

tenderness, or flu-like symptoms.

This article appears on FDA's Consumer Updates page, which features the latest

on all FDA-regulated products.

Date Posted: January 12, 2010

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