FDA Approves Generic Topamax to Prevent Seizures

The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

Topiramate tablets in several different strengths have been approved to be marketed by the following firms: 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.

Prescribing information, or labeling, for generic topiramate will differ from the innovator drug, Topamax, because some uses of Topamax continue to be protected by patents and exclusivity.

The labeling for Topamax and generic topiramate contains an important safety warning about metabolic acidosis, a condition associated with excessive acid in the blood, which can cause symptoms such as tiredness, loss of appetite, irregular heartbeat, and impaired consciousness. Health care professionals should perform a blood test to monitor the level of a patient’s serum bicarbonate.

The use of topiramate has been associated with serious eye problems, such as a sudden decrease in vision and a blockage of fluid in the eye causing increased pressure in the eye. Patients taking topiramate should contact their health care professional immediately if they have a loss in vision or experience eye pain. These problems can lead to blindness if not treated right away.

Note: The Epilepsy Foundation recommends that you talk to your doctor before making any medication switch from brand-name drugs to generic, between different manufacturers of the same generic, or from generic to brand.

Source: FDA press release. For more information, visit www.fda.gov. Reviewed by Epilepsy Foundation Professional Advisory Board member Brian Alldredge, PharmD.