The U.S. Food and Drug Administration (FDA) states that women treated with Topamax (topiramate) and generic equivalents for migraines or epilepsy during pregnancy run an increased risk of their babies developing cleft lip and/or cleft palate (oral clefts).

The FDA said in a 2011 statement that Topomax would be reclassified into Pregnancy Category D. This means that the federal agency recognizes the evidence of human fetal risk based on human data (as opposed to animal studies) but also recognizes that the drug’s potential benefits may be acceptable in certain situations. Packaging of Topomax would include a stronger warning about the risk, the FDA said.

If you took Topomax or a generic drug containing topiramate while pregnant, and your baby was born with an oral cleft deformity, The Driscoll Firm, LLC, can help you to seek compensation for your child’s medical bills and for your pain and suffering. Contact us at our toll-free number or through our online form to discuss the possibility of a legal claim.

Topomax and Oral Cleft Deformity

Topamax (topiramate) is an anticonvulsant manufactured in tablet form. The product is sold by Janssen Pharmaceuticals, Inc., which is a subsidiary of Johnson & Johnson. Topiramate is also sold by several other companies in generic form.

The FDA has approved topiramate for use alone or with other medications to treat patients who have epilepsy and suffer certain types of seizures. It is also approved to prevent migraine headaches. It has also been prescribed for “off-label,” or unapproved uses, according to the FDA.

The FDA warns that, “If you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.”

Other Topomax Side Effects

Topomax can also increase the level of acid in your blood, which is known as “metabolic acidosis,” according to Janssen Pharmaceuticals. If untreated, metabolic acidosis can cause brittle or soft bones or kidney stones, slow the rate of growth in children and may possibly harm your baby if you are pregnant. People with metabolic acidosis may feel tired, lose their appetite, experience changes in their heartbeat or have trouble thinking clearly.

Topomax can also cause confusion, problems with concentration, attention, memory or speech, tiredness and sleepiness, depression or mood problems. Like other antiepileptic drugs, Topomax may cause suicidal thoughts or actions, its manufacturer says.

The most common side effects of Topomax include:

• Tingling and numbness in arms and legs
• Loss of appetite
• Nausea
• Taste change

• Diarrhea
• Weight loss
• Nervousness
• Upper respiratory tract infection.

Contact Our Topomax Side Effects Lawyers

For more than a decade, The Driscoll Firm, LLC, has helped clients injured by dangerous prescription and over-the-counter drugs to seek compensation for their losses. John J. Driscoll represents only plaintiffs. He focuses on complex product liability cases, consumer class actions and personal injury litigation.

If you believe that you have been harmed by taking Topamax (topiramate) or that your baby has a cleft lip or cleft palate because you took Topomax while pregnant, contact The Driscoll Firm, LLC, right away. You have rights that must be protected, including a right to seek compensation for medical expenses and for your pain and suffering.

Call us today or contact us online to receive a review of your case at no charge to you.

For more information:

• Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), U.S. Food and Drug Administration.
• Understanding Topomax side effects, Janssen Pharmaceuticals, Inc.