TITUSVILLE, NJ — Food and Drug Administration approval of Topamax (topiramate) for migraine headaches prophylaxis has been extended to adolescents ages 12 to 17. It was the first FDA approval of a drug for migraine prevention in this age group.
Topamax, which is taken on a daily basis to reduce the frequency of migraine headaches, was first approved by the FDA in 1996 to prevent seizures and then approved for migraine prevention in adults 10 years ago. Topamax is manufactured by Janssen Pharmaceuticals, Inc. of Titusville, NJ.
“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. “Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform healthcare professionals and patients in making treatment choices.”
The FDA noted that about 12% of the U.S. population experiences migraine headaches, and, with many patients experiencing their first migraine attack before reaching adulthood, the condition can be as disabling in teenagers as in adults.
Topamax’s safety and effectiveness in preventing migraine headaches in adolescents ages 12 to 17 was established in a clinical trial that enrolled 103 participants. Those treated with Topamax experienced a decrease in the frequency of migraine of approximately 72% compared with 44% in participants receiving a placebo.
The most common adverse reactions with the approved dose of Topamax (100 milligrams) were paresthesia, upper respiratory infection, anorexia and abdominal pain.
Topamax is required to be dispensed with a Medication Guide cautioning that topamax and all anti-epileptic drugs may increase the risk of suicidal thoughts and behavior. 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 behavior, the FDA said.
Topamax also increases the risk of the development of oral clefts in infants born to women who take the drug during pregnancy. The benefits and risks of Topamax should be carefully weighed before using it in women of childbearing age, the FDA warned, noting that, if a decision is made to use the medication by a woman of childbearing age, effective birth control should be used.