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May 7, 2014 Drug Alert: Association of TEMODAL® (temozolomide) with the risk of liver problems.

May 7, 2014
Drug Alert: Association of TEMODAL® (temozolomide) with the risk of liver problems.


Merck Canada Inc., in consultation with Health Canada, would like to inform you of new important safety information about TEMODAL® (temozolomide) and risk of liver problems. TEMODAL® is an antitumor agent used in combination with radiotherapy in the treatment and maintenance therapy of some brain cancers. TEMODAL® may cause liver problems which may, in some cases, result in death. Liver problems may occur several weeks after starting treatment with TEMODAL® or after treatment has been stopped. If you are using TEMODAL®, your doctor will be monitoring you for signs of liver problems with blood tests as appropriate for your condition. It is important to tell your doctor if you already have liver problems.

Contact your doctor if your skin or the whites of your eyes turn yellow, you feel tired or have flu-like symptoms, your urine is dark or brown, your stools are discoloured and/or pale, you experience itching, you have nausea or vomiting, you have pain on the right side of your stomach just below the ribs, or you do not have an appetite. These may be signs of liver problems. Merck Canada Inc. has sent a letter to health care professionals informing them of this important safety information.