Migraine/Epilepsy Drug Topamax (Topiramate) Causes Cleft Palate and Cleft Lip Birth Defects

Topamax, generic name Topiramate, is a drug approved for the treatment of epilepsy and migraine prevention. When used by pregnant women, it significantly increases the risk of their babies having cleft lips and cleft palates, birth defects that are collectively referred to as oral clefts. The risk of oral clefts from Topamax was only recently revealed to consumers when, on March 4, 2011, the FDA issued a safety announcement to publicize the risk. The Topamax lawyers at DeCarli Law are actively investigating these injuries.

Topamax Developed as a Treatment for Epilepsy, and Later Approved for Migraine Prevention

Topamax (generic name Topiramate) was originally developed and produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. Topamax was first approved by the FDA to treat epilepsy in 1996. It is used with other medications to treat a variety of forms of epilepsy, including simple partial seizures, complex partial seizures, generalized tonic-clonic seizures, and Lennox-Gastaut syndrome. Topamax also has been approved for use to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur.

FDA Issues Safety Alert that Topamax/Topiramate Causes Cleft Palates and Cleft Lips

On March 4, 2011, the FDA issued a safety announcement warning that when pregnant women use Topamax and its generic equivalent, they risk their babies developing cleft lips and cleft palates. The FDA also reclassified Topamax/Topiramate as a Pregnancy Class D drug because of the risk of birth defects. This classification means “[t]here is positive evidence of human fetal risk based on adverse reaction data from investigating or marketing experience or studies in humans.” Previously, Topamax had only been classified as a Pregnancy Class C drug, reflecting a mistaken belief regarding its safety.  You may learn more about the difference between a Pregnancy Class C drug and a Class D drug HERE.

New Topamax Label Warns Against Use by Pregnant Women or by Women of Childbearing Potential

In recognition of the risk of birth defects, the FDA now requires Topamax and Topiramate to have a specific warning of the potential hazard to the fetus from exposure to Topamax.

The warning label now discloses the risk of cleft lips and cleft palates, and advises that contraception should be used when women take Topamax. This is particularly important because the risk of oral clefts to the fetus occur in the first trimester of pregnancy, before many women know they are pregnant. The warning also advises that alternative treatments should be considered, especially when Topamax is not being used for treatment of a life-threatening injury.  The complete text of the relevant portions of the new Topamax warning may be found HERE.

Women who used Topamax before March 4, 2011 received none of these warnings.

Topamax Manufacturer Fined $80 Million for Illegal Marketing

Although Topamax is only approved for treating epilepsy and preventing migraines, its manufacturer has illegally encouraged doctors to use it for other conditions. Among the unapproved -- or “off label” -- uses are for bipolar disorder, cluster headaches, weight loss, PTSD, and alcoholism.

Government officials have punished the manufacturer of Topamax for this illegal behavior. In April 2010, Topamax manufacturer Ortho-McNeil agreed to pay $6.14 million in criminal fines, and $75.37 million in civil penalties for illegally promoting Topamax for treatment of psychiatric conditions.

Topamax Birth Defect Lawsuits

When a woman has given birth to a child with a cleft lip or cleft palate after taking Topamax or Topiramate while pregnant, both she and her child may have a legal claim against the drug manufacturer. DeCarli Law’s Topamax lawyers offer free, no-obligation telephone consultations for women whose children were born with oral clefts after using Topamax. Feel free to use the contact form on this page, or call our toll free number, to get more information. Because every state has rules called statutes of limitations that impose deadlines on when a legal claim may be made, please do not delay in seeking legal advice.