Teva Pharmaceutical Industries Ltd. said the Food and Drug Administration has given its approval for the company’s abbreviated new drug application to market its generic version for Ortho-McNeil’s anticonvulsant Topamax tablets, 25 mg, 50mg, 100mg and 200 mg.

 

Topamax, generically known as topiramate, is indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome, a severe form of epilepsy that is characterized by the onset in early childhood of frequent seizures of multiple types, developmental delay, a particular brain wave pattern and behavioral disturbances with poor social skills and attention-seeking behavior. The seizures in this syndrome are notoriously hard to treat and may lead to falls and injuries.

 

Topamax’s sales were approximately $2.4 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.

 

Among side effects of the drug are abdominal pain, abnormal coordination, abnormal vision, agitation, anorexia, anxiety, appetite loss, back pain, breast pain, chest pain, confusion, constipation, depression, difficulty with concentration, difficulty with memory, dizziness, double vision, drowsiness, fatigue, flu-like symptoms, indigestion, language problems, leg pain, loss of coordination, menstrual problems, mood problems, nausea, nervousness, nose inflammation, rash, sinusitis, slowing of movements, sore throat, speech problems, tingling or burning sensations, tremors, weakness, weight loss.

 

Some of the side effects are more likely to surface with high doses of Topamax. Others occur regardless of dosage. While many tend to disappear after the first 8 weeks of therapy, it's still important to report them to your doctor. Only your doctor can determine if it is safe for you to continue taking Topamax.