Since 1996, doctors have prescribed Topamax (generic: topiramate) as an anticonvulsant that prevents epilepsy-related seizures. It was only recently, in March 2011, that the FDA concluded Topamax therapy in pregnant moms may result in higher risks of developing a cleft lip or cleft palate in newborns.
Topamax Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Topamax, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 223-3784.
What birth defects are linked to Topamax?
The FDA has linked Topamax to increased risks of oral clefts, which are more commonly known as:
Topamax Overview
Manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Topamax was FDA approved in December 1996. It is prescribed as a seizure medication, or an anticonvulsant. Used alone or in combination with other medications, it is used to treat epilepsy-related seizures or to prevent migraines.
The FDA reports that between January 2007 and December 2010, 32.3 million prescriptions for Topamax or its generic were dispensed.
Unfortunately, after new data became available in March 2011, the FDA relabeled Topamax from a Category C to a Category D drug, as a study proved it was related to dangerous birth defects, including oral clefts in newborns. Also known as a cleft lip or cleft palate, oral clefts are birth defects in which the tissues of the mouth or lip do not form properly during fetal development, particularly the first trimester.
While cleft lips and palates are usually successfully treated with surgery, the severity of the birth defects caused by Topamax may lead you or somebody you know to contact a Topamax birth defect lawyer or attorney with our firm to discuss the potential for a Topamax birth defect lawsuit.
FDA Study and Warning
In a March 4, 2011 Safety Communication, The FDA announced there was an increased risk of oral clefts in children born to mothers taking Topamax (or the generic form of topiramate) during pregnancy.
Data reviewed by the FDA from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicated children born to women who took Topamax during pregnancy had a higher risk of developing a cleft lip or cleft palate than children born to mothers who did not. Related data from the UK Epilepsy and Pregnancy Registry found similar results, with infants exposed to Topamax at a 16-times higher risk of cleft lip or cleft palate than those in the general population.
The NAAED study found that 1.4% of infants exposed to topiramate during pregnancy developed a cleft lip or cleft palate — this is compared to 0.38%-0.55% in infants exposed to other anti-epileptic drugs, and 0.07% of mothers who do not use any anti-epileptic drugs.
Because there was convincing evidence based upon human data, the FDA recommended that Topamax be reclassified with a more serious Category D warning, instead of a Category C. A Category D warning advises patients and doctors that there is a strong risk of fetal harm, proven in both animal and human studies.
Topamax and Cleft Lip and Cleft Palate
Cleft lip and cleft palate occur when parts of the lip or palate do not fuse properly during the first trimester. A cleft is a fissure, opening or gap. Cleft lip and cleft palates range anywhere from a small notch in the lip to a groove that runs into the roof of the mouth and nose. It can cause problems with eating, talking or ear infections. Surgery is often necessary to close the lip and palate.
A cleft palate is a condition where the two plates that form the roof of the mouth, also known as the hard palate, are not completely joined. It creates a hole in the roof of the mouth that can connect the mouth directly to the nasal cavity.
In most cases, a cleft lip is also present. A cleft lip occurs when the maxillary and medial nasal processes, known as the primary palate, do not fuse. It results in either an indentation or a gap of the lip, which can stretch to the nose. While they usually occur simultaneously, a cleft lip can occur without a cleft palate.
FDA Recommendation
In the March 4, 2011 Safety Announcement, the FDA recommended patients and doctors should weigh the benefits and risks of topiramate use in women of childbearing age — not just women who are already pregnant.
The palates develop early on in the first trimester of pregnancy, during a time that most women don’t even know they’re pregnant yet. Therefore, a cleft lip or cleft palate may occur in a fetus before a woman even knows she may be expecting a child.
For this reason, the FDA recommends alternative medications should be considered for women who are of child-bearing age.
The FDA said:
“Women of childbearing age who do decide to take topiramate and are not planning a pregnancy should use effective birth control (contraception) while taking topiramate. Women should talk to their healthcare professionals about the best kind of birth control to use while taking topiramate.”
Off-label Topamax Use
While Topamax is primarily prescribed for seizure and migraine prevention, it is also used for off-label uses. These uses include treating obesity, bipolar disorder and alcoholism.
Due to the severity of the birth defects associated with Topamax, a patient should talk to their doctor before deciding to take Topamax or a generic.
Is there a time limit in filing a Topamax birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their Topamax lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 223-3784.
We hope we will be able to assist you with your potential Topamax birth defects lawsuit and look forward to speaking with you.
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