Ministry requires insert for Voltaren after FDA warning

The Health Ministry is requiring a warning be added to the patient insert for the gel and other forms of the popular pain reliever and anti-inflamatory Voltaren. It cautions that extended use could cause liver damage.

Following warnings issued by the U.S. Food and Drug Administration, at the beginning of the week, the ministry is requiring a patient insert of similar warnings for Voltaren and other medications containing the same active ingredient, diclofenac; those sold in Israel include Abitren, Arthrortec, Dicloren, Physicare and Betaren. They are highly popular medications thought to be used by hundreds of thousands of Israelis every year as an ointment, salve, gel, pill or injection, primarily for orthopedic patients. Medications containing diclofenac are also sold without a prescription under such names as Voltaren Emulgel, Voltaren Acti-Go and Dicloren Gel.

Over the weekend, the U.S. Food and Drug Administration issued a warning regarding serious side affects associated with Voltaren 1% Gel, involving disruptions to liver function. In a joint announcement to health care professionals, the FDA and the manufacturers of Voltaren, the Novartis and Endo pharmaceutical firms, said recent reports on medications containing diclofenac, which is Voltaren's active ingredient, contained information about patients developing severe liver problems, including death of liver cells, jaundice, hepatitis and liver failure.

The reports included the death of patients or the necessity for a liver transplant. Most of the reports pertained to the first month of use by patients, but it was determined the severe complications could result at any stage of use. American doctors are being directed to conduct blood tests to monitor the liver function of patients who need to take Voltaren 1% Gel for an extended period.

The Novartis Israel office noted that the FDA advisory was to make the warning on the gel consistent with those for other forms of the medication containing the active ingredient diclofenac, including oral medications, and noted that potential effects on the liver were already noted in the patient insert sold with oral Voltaren.

The FDA recommended that liver function tests be conducted within four to eight weeks of initial use of Voltaren Gel. An announcement by Novatis and Endo said that to reduce the risk of liver complications, "the lowest effective dose should be used for the shortest duration possible." The companies' announcement also called on physicians to make sure their patients who are using the drug are aware of the symptoms of a decline in liver function, including fatigue, nausea, rash and flu symptoms.

Teva Pharmaceuticals, which makes Abitren, said: "Following the FDA announcement and the order issued by the [Israeli] Health Ministry on December 13, the Teva registration department that same day provided the Health Ministry updated leaflets for doctors regarding the relevant Teva products, Abitren tablets, suppositories and injections. We wish to note that the existing patient insert on the market already notes the need to conduct periodic liver function tests and at the same time to refrain from use [for patients] with a background of liver or kidney disease. Although the U.S. FDA announcement pertained to the gel form of the medication, Teva broadened its [warning] to all forms. The updated inserts are awaiting Health Ministry approval before they are distributed."