Topomax is an anticonvulsant medication prescribed for migraines and to treat epilepsy patients who have certain types of seizures. According to the U.S. Food and Drug Administration (FDA), Topomax may increase the risk of cleft lip or cleft palate in the babies of pregnant women who use the drug.

The FDA warned the public and healthcare professionals of the risk posed by topiramate, which is marketed as Topomax, in March 2011. The agency reclassified the drug in its Pregnancy Category D. Being placed in this class means there is positive evidence of human fetal risk based on human data, but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.

If you took Topomax while pregnant, and your baby was born with an oral cleft deformity (cleft lip or cleft palate) or other deformities, contact The Driscoll Firm, LLC, today by phone or through our online form to discuss the possibility of our skilled and experienced lawyers pursuing a Topomax lawsuit on your behalf.

FDA Warnings About Topomax (topiramate)

The FDA approved Topamax for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. It was also approved for use to prevent migraine headaches but not to relieve the pain of migraine headaches once they occurred. The drug has also been used off-label (for unapproved uses) for other conditions, the FDA reports.

In March 2011, the FDA said that data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicated an increased risk of oral clefts – cleft lip and cleft palate – in infants exposed to topiramate during the first trimester of pregnancy. Infants whose mothers took Topomax and its generic versions as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent to 0.55 percent in infants exposed to other antiepileptic drugs.

The FDA said packaging of Topomax would include a stronger warning about the risk the drug poses to pregnant women and their babies. The agency advised that, before prescribing topiramate, health care professionals should warn patients of childbearing age about the potential hazard to their fetus if they become pregnant while using the drug.

The FDA also said in a news release about its warning that health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age. It said alternative medications that have a lower risk of birth defects should be considered.

Topomax has also been associated with serious eye problems, such as a sudden decrease in vision and a blockage of fluid in the eye, which causes increased pressure in the eye, according to the FDA. These problems can lead to blindness if not immediately treated.

The FDA also notes that labeling for Topamax and generic topiramate contains a safety warning about metabolic acidosis. This condition is associated with excessive acid in the blood, which can cause symptoms such as tiredness, loss of appetite, irregular heartbeat and impaired consciousness.

From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed and approximately 4.3 million patients filled topiramate prescriptions from outpatient retail pharmacies in the U.S., the FDA reports.

Topamax (topiramate) tablets are sold by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson.

In April 2009, the FDA approved sales of topiramate tablets in generic form at several different strengths 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.
• Pliva Hrvatska.

Contact a Topomax Birth Defects Lawyer

The Driscoll Firm, LLC, believes that manufacturers who market and sell drugs to healthcare professionals and/or patients are obligated to ensure their products are safe and work as advertised. When patients (or the babies of pregnant women) are injured by a defective drug, they have a right to seek compensation for medical expenses, including corrective surgeries, as well as for lost income, pain and suffering and other losses.

For more than a decade, The Driscoll Firm, LLC, has helped clients injured by dangerous pharmaceuticals and medical devices obtain compensation for their losses. John J. Driscoll solely represents plaintiffs and focuses his practice on complex product liability cases, consumer class-action lawsuits and other personal injury litigation.

Call us today or submit our online form to talk to a lawyer about your legal rights and options if you believe you or your child has been injured to use of Topomax. This is a free and confidential consultation.

For more information:

• FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), U.S. Food and Drug Administration
• FDA Approves Generic Topamax to Prevent Seizures, FDA
• Topomax (topiramate) – Migraines, Janssen Pharmaceuticals, Inc.
• Topomax (topiramate) – Epilepsy, Janssen Pharmaceuticals, Inc.