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Topamax and Cleft Palate

Repeated surgeries and years of treatment for a child’s cleft palate or cleft lip could be necessitated by birth defects related to the prescription drug Topamax, which many mothers have taken for epilepsy, migraines and off-label uses.

Studies have shown that Topamax can increase the rate of oral cleft birth defects by up to 20 times. Oral cleft birth defects occur when the lip and/or the palate fail to fully come together during gestation. Surgery is required to correct cleft palates and cleft lips, and children may have to endure several procedures through their teenage years.

Left untreated, oral cleft birth defects can cause serious eating, speaking and hearing problems, not to mention social development problems caused by the defect’s appearance.

The parents of newborns who suffered oral cleft birth defects due to the mother’s use of Topamax (topiramate) during pregnancy could be entitled to compensation for their drug injuries. Lawsuits over medication side effects are essentially product liability matters, but they also involve a lot of medical malpractice law.

The law firm of Gemma Law Associates, Inc., has years of experience handling Rhode Island medical malpractice and product defect cases, including birth injuries caused by prescription drugs. We fight to protect the rights of patients and their families. Call us toll-free or fill out our online contact form for a consultation about your case.

We represent clients throughout Rhode Island including the areas of Providence, Newport, Bristol, Cranston, Woonsocket, and Pawtucket.

Oral Cleft Birth Defects, Topamax and FDA Action

The U.S. Food and Drug Administration first approved Topamax for treatment of epilepsy in 1998 and later, in 2004, approved it for combating migraine headaches. Topamax has also been used for many off-label purposes, such as treating bulimia, alcoholism, bipolar disorder and obsessive-compulsive disorder.

In addition to its generic name, topiramate, Ortho-McNeil Neurologics, and other drug makers have marketed the drug under these names:

  • Topamax;
  • Topamax Sprinkle; and
  • Topiragen.

Medical studies have shown that Topamax and its chemically identical twins significantly increase the likelihood of oral cleft birth defects when a mother takes the drug, particularly during the first trimester. The prevalence of oral cleft birth defects has led the FDA to list Topamax as a pregnancy category D medicine, meaning there is evidence of risks posed to human infants.

Oral cleft birth defects can result in a cleft lip, where the lip has a notch in it that can extend up into the child’s nostril. In instances of a cleft palate, there is a gap in the palate itself, often including the nasal passage. A cleft palate can also affect the child’s teeth.

The only way to correct oral cleft birth defects is with surgery — and often a series of operations. Many children with oral cleft birth defects will also require speech therapy, and they are more prone to serious inner-ear infections.

Contact Rhode Island Drug Injury Lawyers Today

If you suspect your child’s oral cleft birth defects were caused by Topamax, you should seek legal assistance as soon as possible. Even if you are unsure, the Providence, Rhode Island, prescription drug birth defect attorneys of Gemma Law Associates, Inc., can review your case and advise you. Contact us today toll-free or fill out this form.


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