FDA Okays Topamax for Prevention of Migraine in Adolescents

The U.S. Food and Drug Administration gave clearance to Topamax, the first drug approved to prevent migraine headaches in teenagers.

Topamax (topiramate) was initially approved by the federal agency in the year 1996 to prevent seizures. It was in 2004 that the drug was approved to prevent migraine in adults. This is the first time the drug will be used to prevent migraine headaches in adolescents of age 12-17. The drug is approved to be taken on a daily basis to decrease the frequency of migraine headaches.

"Migraine headaches can impact school performance, social interactions, and family life," Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a news 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 newly approved drug's safety and effectiveness in preventing migraine in adolescents was tested through a clinical trial conducted on 103 participants. It was seen that those treated with Topamax experienced a reduction in the frequency of migraine headaches by nearly 72 percent when compared to 44 percent of the control group that were treated with a placebo.

When treated with the approved doze of 100 milligrams of Topamax, the common adverse side effects noticed was paresthesia, a burning or prickling sensation that was felt in hands, arms, legs or feet, infection in the upper respiratory, anorexia and pain in the abdomen.

The federal agency warns that Topamax must be dispensed with a clear Medication Guide that reveals safety information of the drug.  The user must be aware that Topamax, an anti-epileptic drug, increases the risk of suicidal thoughts and behavior. Hence, the user must be informed of the need to be alert for the emergence as well as signs and symptoms of depression and the alteration in mood or behavior.

According to the Health Union, over 37 million U.S. people suffer from migraines of which, 13 percent are adults. 2-3 million of them suffer from chronic pain. Migraine occurs most often in women and those from low income groups. There are 5 million American who suffer with at least one migraine attack per month.

Pregnant women taking Topamax increase the risk of infants to be born with cleft lips and /or cleft palate. The drug is manufactured by Jansen Pharmaceuticals.