Wednesday, April 16, 2014
First Migraine Drug Approved for Use in Adolescents
For the first time, the US Food and Drug Administration (FDA) has approved the drug topiramate (Topamax) for migraine prevention in adolescents, ages 12 to 17. Topiramate is indicated for daily use in order to reduce the frequency of migraine headaches. The drug was first approved by the FDA in 1996 to prevent seizures. In 2004, topiramate was approved for migraine prevention in adults.
The approval is based on safety and efficacy data from a clinical trial of 103 adolescents (ages 12 to 17). The trial showed a significant decrease (p=0.016) in monthly migraine frequency in those individuals taking 100 mg of topiramate (72 percent) compared with those taking placebo (44 percent). The study was published in a 2009 edition of Pediatrics by Donald Lewis, MD, of Eastern Virginia Medical School, and colleagues.
Common adverse effects included paresthesia, upper respiratory infection, loss of appetite, and abdominal pain. The FDA warned that the drug should be dispensed with a Medication Guide that provides safety information about the drug. Some potentially serious side effects may include suicidal thoughts and behavior, depression, unusual changes in mood or behavior, and birth defects in infants born to women who take the drug during pregnancy.
Topiramate is manufactured by Janssen Pharmaceuticals, Inc. of Titusville, N.J.
Read our previous stories on migraine in adolescents: http://bit.ly/QpP6CQ.