New Migraine Prevention for Teens
Teenagers suffering from migraine headaches now have a new FDA-approved option.
Topamax (topiramate) has won approval for the prevention of migraines in teens (12-17 year olds) “This is the first FDA approval of a drug for migraine prevention in this age group,” according to a press release from the agency.1
Migraines in Teens
About 12% of the population experiences migraine headaches. Although migraines occur less frequently in teens (0.79% of population), the impact of the disease appears to be greater than in adults.2
In teenagers, “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 … will help to inform health care professionals and patients in making treatment choices.”
Migraine headaches are characterized by episodes of throbbing and pulsating pain in the head, and may occur several times per month. Other common symptoms include increased sensitivity to light, noise, and odors, as well as nausea and vomiting. Many patients experience their first migraine attack before reaching adulthood and, for many teenage girls, may be associated with puberty and menstruation cycles.
Teens are Not “Little Adults”
Topamax, which is taken daily to reduce the frequency of migraine headaches, was first approved to prevent seizures in 1996. It later won approval for the prevention of migraines in adults in 2004. When it comes to medication management, teens are not “little adults.” One difficulty facing physicians is judging the safety of a medication approved for adults in this patient population.
Therefore, the FDA required the manufacturer of Topamax, Janssen Pharmaceuticals, to conduct safety and effectiveness studies specifically in adolescents. The clinical trial enrolled 103 teens, aged 12-17 years. The study found that teens treated with Topamax (100 mg) experienced a 72% decrease in the frequency of migraine compared to 44% in participants that took an inactive drug (placebo).
The most common adverse reactions in the study was a burning or prickling sensation felt in the hands, arms, legs, or feet; upper respiratory infection; anorexia (loss of appetite); and abdominal pain.
“Topamax must be dispensed with a Medication Guide that describes important safety information about the drug,” noted the agency. “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.”
For teenage girls, 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. Therefore, the FDA warns that “the benefits and risks of Topamax should be carefully weighed before using it in women of childbearing age.” If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used, they noted.