FDA Approves Janssen's Topamax For Migraine Prevention
By Cyndi Root
The Food and Drug Administration (FDA) announced in a press release that they have approved Topamax. The Janssen Pharmaceutical drug is indicated for migraine headache prevention in adolescents ages 12 to 17 — the first approval for migraines in this age group. Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said, “Migraine headaches can impact school performance, social interactions, and family life. 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.”
Migraine Headaches
Migraine headaches are no ordinary headaches. They are neurological disorders, often inherited. Some individuals are genetically more susceptible to this painful and debilitating condition. Migraines often start before a person becomes an adult and continue throughout a person’s life. Triggers like light, hormone fluctuations, noise, certain foods, and other stimuli may start a migraine headache. Patients feel pain, throbbing, nausea, and may vomit. In many cases, no trigger is identifiable. In the U.S., about 12 percent of people get migraines.
Topamax
Topamax was approved by the FDA in 1996 for seizures. In 2004, it was approved for migraines. Patients take Topamax on a preventative basis as daily dosing reduces the frequency of episodes. The FDA approved the drug for adolescents based on a clinical study with 103 people ages 12 to 17. Participants took Topamax or a placebo. On Topamax, patients decreased the frequency of migraines by 72 percent compared to 44 percent for the placebo group.
Topamax is distributed with a Medication Guide. The FDA cautions the public and medical professionals that the drug has known side effects including a prickly sensation in the limbs, loss of appetite, abdominal pain, and upper respiratory infections. Like other anti-epileptic drugs, Topamax may increase the risk of depression, mood changes, and suicidal thoughts or behavior. Women of childbearing age should evaluate the risk of cleft lip or cleft palate.
Topamax on Trial
Janssen Pharmaceuticals has lost two court trials over Topamax, and faces about 100 more suits filed in the Philadelphia Courts, First Judicial District of Pennsylvania, Court of Common Pleas. Plaintiffs successfully argued to the jury that Topamax caused birth defects in their children. In 2011, the FDA issued a drug safety communication warning consumers of increased risks for cleft lip and palate in infants.