The US Food and Drug Administration (FDA) today approved topiramate (Topamax, Janssen Pharmaceuticals Inc) for the prevention of migraine headache in adolescents aged 12 to 17 years.
"This is the first FDA approval of a drug for migraine prevention in this age group," a statement from the FDA notes. Topiramate was first approved in 1996 as an antiepileptic drug and was later approved in 2004 for migraine prophylaxis in adults.
"Migraine headaches can impact school performance, social interactions, and family life," said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research in a statement. "Adding dosing and safety information for the adolescent age group to the drug's prescribing information will help to inform health care professionals and patients in making treatment choices."
The safety and effectiveness of topiramate in preventing migraine headaches in this age group were established in a clinical trial that enrolled 103 participants. Frequency of migraine decreased by approximately 72% in treated patients vs 44% in participants receiving placebo.
The most common adverse reactions with the approved dose of topiramate (100 mg) were paresthesia, upper respiratory tract infection, anorexia, and abdominal pain.
The agency notes that the drug must be dispensed with a Medication Guide that describes important safety information.
"Topamax and all antiepileptic drugs may increase the risk of suicidal thoughts and behavior, and patients should be advised of the need to be alert for the emergence of, or worsening of, the signs and symptoms of depression, or unusual changes in mood or behaviour," the FDA notes.
Topamax increases the risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women who take the drug during pregnancy; the benefits and risks of treatment should be carefully weighed before it is used in women of childbearing age, the FDA notes. "If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used."