Generic Topamax (Migrane Drug) Earns FDA Approval For Seizures

For the first time, the Food and Drug Administration has approved generic versions of Topamax tablets to prevent seizures.

Several drug companies have been given the go-ahead to begin marketing topiramate, giving consumers a less-expensive option for treating conditions that result in seizures. Topiramate tables will be available in different doses offered by the following companies: Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Barr Laboratories Inc., TEVA Pharmaceuticals USA, Ranbaxy Laboratories Ltd., CIPLA Ltd., Glenmark Generics Ltd., Cobalt Laboratories, Apotex Inc., Zydus Pharmaceuticals USA, Aurobindo Pharma Ltd., Torrent Pharmaceuticals Ltd., Invagen Pharmaceuticals Inc., Unichem Laboratories Ltd., Sun Pharmaceuticals Ltd. and Pliva Hrvatska.

Topamax, the brand name version of topiramate, is approved to treat migrane headache and will remain approved for additional uses not approved for the new generic versions, officials said.

Risks of Using Topiramate

Topamax and generic topiramate carry risks of injury, including metabolic acidosis. People with metabolic acidosis have excess levels of acid in the blood and may suffer from symptoms including fatigue, loss of appetite, impaired consciousness, and heart arrhythmia (irregular heartbeat). Patients beginning a regimen including the drugs should have a blood test to monitor the level of serum bicarbonate, the FDA said.

The use of topiramate also has been associated with serious eye problems, including a build-up of fluids in the eye, causing increased pressure in the eye and a sudden decrease in vision. If not treated properly, these side effects may cause blindness. People taking topiramate are advised to consult with their health care provider if they experience vision changes.

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