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New research suggests that the side effects of Topamax and Elavil may make the drugs too dangerous for use in treating children with migraines.
In a study published in the New England Journal of Medicine on January 12, researchers with the Cincinnati Children’s Hospital Medical Center compared the effectiveness of the anti-seizure medication Topamax (topiramate), the antidepressant Elavil (amitriptyline), and a placebo for children suffering from migraine headaches.
According to the findings, the potential risks associated with the medications outweigh the benefits, as the prescription treatments did not appear to be any more effective than the placebo.
The study involved a randomized, double-blinded, placebo-controlled trial where 361 youths between the ages of 8 and 17 were given either 2 mg per day of Topamax, 1 mg per kilogram per body weight per day of Elavil or a generic equivalent, or a placebo. Researchers looked for a relative reduction of 50% or more in the number of headache days the children suffered over a 24-week period, comparing it to the number suffered by the children over a 28-day period before they began taking the medications or the placebo.
The study found that there were no significant differences in the rates of migraines suffered by children in the three groups. However, children who received the actual drugs had a higher rate of adverse events.
Those given Elavil suffered higher rates of fatigue and dry mouth, and those given Topamax suffered from weight loss and paresthesia; which can be a sign of peripheral nerve damage and causes a “pins and needles” sensation.
In addition, the researchers reported that there was one suicide attempt in the Topamax group, and three cases of seriously altered moods in children given Elavil.
“There were no significant differences in reduction in headache frequency or headache-related disability in childhood and adolescent migraine with amitriptyline, topiramate, or placebo over a period of 24 weeks,” the researchers concluded. “The active drugs were associated with higher rates of adverse events.”