The FDA has approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken daily basis to reduce the frequency of migraine headaches.
Topamax is manufactured by Janssen Pharmaceuticals and was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004. The safety and effectiveness of Topamax 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 percent compared to 44 percent in participants that took an inactive drug (placebo).
The most common adverse reactions with the approved dose of Topamax (100 milligrams) were paresthesia (a burning or prickling sensation felt in the hands, arms, legs, or feet), upper respiratory infection, anorexia (loss of appetite), and abdominal pain. However, Topamax and all anti-epileptic 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 behavior.
Additionally, Topamax has been shown to increase 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. If a woman of childbearing age uses Topamax, effective birth control should be used.
[1] FDA News Release "FDA approves Topamax for migraine prevention in adolescents," March 28, 2014.
[2] FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate) (03/04/2011).
Topamax is manufactured by Janssen Pharmaceuticals and was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004. The safety and effectiveness of Topamax 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 percent compared to 44 percent in participants that took an inactive drug (placebo).
The most common adverse reactions with the approved dose of Topamax (100 milligrams) were paresthesia (a burning or prickling sensation felt in the hands, arms, legs, or feet), upper respiratory infection, anorexia (loss of appetite), and abdominal pain. However, Topamax and all anti-epileptic 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 behavior.
Additionally, Topamax has been shown to increase 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. If a woman of childbearing age uses Topamax, effective birth control should be used.
[1] FDA News Release "FDA approves Topamax for migraine prevention in adolescents," March 28, 2014.
[2] FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate) (03/04/2011).
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