Topamax FDA Approved for Migraine Prevention

Patient Expert

by Teri Robert, MyMigraineConnection Lead Expert

Migraine prevention is one of the most important issues facing Migraineurs who experience frequent and / or debilitating Migraine attacks. The vast majority of medications in use for Migraine prevention (more than 100 medications) are prescribed off-label. That means that they're approved for use by the U.S. Food and Drug Administration (FDA), but not specifically for the prevention of Migraine. This is a quite common practice, not only in treating Migraine, but for other conditions as well.

In August, 2004, the FDA approved Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules for the prophylaxis (prevention) of Migraine attacks in adults. In clinical studies with Topamax, many people with Migraines experienced significantly fewer attacks, enabling them to help manage their condition. The approval of Topamax, brings the number of medications approved for Migraine prevention to four. The other three are Depakote and Depakote ER (divalproex sodium), Inderal LA (propranolol), and Blocadren (timolol).

Clinical trials found that patients receiving the recommended daily dose of Topamax experienced a significant reduction in monthly Migraine attacks, compared with placebo.

"Many people who suffer from frequent or severe Migraines may benefit from preventive therapy... for people who experience frequent Migraine attacks, Topamax may have a significant impact by helping to reduce how often they occur... Many people who may be candidates for Migraine prevention are not offered this as an option. Physicians are more likely to recommend appropriate treatment when patients fully discuss their condition.

Dr. Elizabeth Loder, Assistant Professor of Medicine,

Harvard Medical School Headache Management Program

"I work and have a family to take care of so having fewer Migraines is very important to me... Taking Topamax for my Migraines reduced the number of Migraines I had each month, allowing more time for the things I wanted to do."

Sandra Bryan, a Topamax clinical trial patient

Migraineurs should talk to their doctors about the treatment options that are right for them. Factors to discuss include:

  • the frequency and severity of their Migraines;
  • the impact of Migraine on their daily activities;
  • medications they are currently using;
  • how often they are using their Migraine medications;
  • and how well their current Migraine medications are working.

Last updated May 31, 2007