Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

The US Food and Drug Administration’s recent approval of Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Topamax (topiramate), the first preventive treatment for episodic migraines in patients aged between 12 and 17 years, will ensure the drug’s effective dosage for adolescents suffering two or more migraine attacks a month. However, potential side-effects mean that concerns may still be raised around its use, says an analyst with research and consulting firm GlobalData.

According to Alvina To, GlobalData’s therapy analyst covering neurology, the latest approval for Topamax was supported by a randomized and placebo-controlled efficacy and safety clinical trial in 103 patients, who had at least six months of migraine history. The results showed that Topamax significantly lessened monthly migraine attacks in 72% of participants, compared with 44% of those taking placebos.

The analyst says: “Migraine is experienced by both children and adults alike. For children in particular, these symptoms can affect school performance, social interactions and family life. The good news is that Topamax proved safe and well-tolerated in this patient group. Along with Depakote (divalproex sodium), this is now the only other anti-epileptic drug that has been approved by the FDA for migraine prevention.”