A few people have serious reactions to Carbatrol. These serious problems are very rare but everyone who takes this medicine should at least be aware of them because a very small number of people have died because of them.

On December 12, 2007, the Food and Drug Administration informed healthcare professionals that dangerous or even fatal skin reactions (called Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine, the active ingredient of Carbatrol, are significantly more common in patients who have a particular type of gene, called “HLA-B*1502”. This gene occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from these areas in which HLA-B*1502 is present should have a blood test by their physicians to see if they have the “HLA-B*1502” gene before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is even true for patients who test positive for HLA-B*1502. (source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine)

Other serious side effects from Carbatrol and other forms of carbamazepine are certain kinds of blood abnormalities. Only about 1 in 30,000 people who take carbamazepine will develop one of these disorders, but the risk is higher than the risk for other people. The doctor will probably recommend a complete blood test before starting Carbatrol. Then it will be possible to recognize and follow any changes that occur. Many people do have some small changes in their blood that reverse on their own.

The first symptoms of a blood disorder may include:

• fever
• sore throat
• sores in the mouth
• nosebleeds or other unusual bleeding or bruising
• tiny red spots on the skin

If you notice any of these things, call the doctor right away, but do not stop using the Carbatrol unless the doctor says so.

Liver problems are another serious disorder that occurs in a few people who take Carbatrol. These may be the first symptoms:

• yellow eyes or skin
• loss of appetite
• upset stomach with vomiting
• black or pale bowel movements

Tell the doctor right away if you notice any of these problems, but don't stop using the Carbatrol unless the doctor says so.

 

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If you believe that you have experienced a serious side effect from a medication, you or your physician can bring it to the attention of the FDA, through their MedWatch program, by completing an adverse event report form (http://www.fda.gov/medwatch/getforms.htm). MedWatch is the FDA's program for reporting serious reactions and problems with medical products, such as drugs and medical devices. (http://www.fda.gov/medwatch/getforms.htm.) To learn more about the Medwatch program go to: http://www.fda.gov/medwatch/report/consumer/consumer.htm

 

Last Revised: 12/14/07