Topamax and Oral Cleft Risks - Consumer Justice Foundation

Topamax and Oral Cleft Risks

Written by Faith Anderson on June 14, 2011
Baby with Cleft Palate

The Antiepileptic Drug, Topamax

Antiepileptic drugs like Topamax were originally developed as a primary treatment for individuals suffering from epilepsy. However, many of these medications have been FDA-approved for additional indications, and some are even prescribed for off-label uses at the discretion of healthcare professionals. Topamax, for example, was approved by the FDA in 1996 to treat partial onset seizures and generalized tonic-clonic seizures associated with epilepsy, although the FDA added an indication for the prevention of migraine headaches in 2004. In some cases, Topamax may be prescribed off-label, for the treatment of bulimia nervosa, obsessive-compulsive disorder, and neuropathic (nerve) pain. The drug company responsible for manufacturing Topamax is Ortho-McNeil Pharmaceutical, a division of pharmaceutical giant, Johnson & Johnson.

Potential Topamax Cleft Palate and Cleft Lip Birth Defects

Both cleft palate and cleft lip are birth defects characterized by the malformation of one of a child’s oral structures. These potential Topamax birth defects occur when there is an interruption in the development of a fetus in utero, preventing the child’s palate or upper lip from forming properly. In children born with a cleft palate, the palate, or roof of the mouth, fails to fuse together completely due to a lack of tissue in the palate area as the structure was forming. A cleft palate can involve either the bony front portion of the mouth or the soft back portion of the mouth, and can range from a small hole at the back of the mouth to a nearly complete separation of the roof of the mouth. Cleft lip is similar to a cleft palate in nature, but involves the malformation of a child’s upper lip. A cleft lip presents as a vertical fissure in one or both side of the upper lip, varying from a small notch in the lip to a severe opening that extends up through the nose.

The side effects resulting from alleged Topamax cleft palate and cleft lip birth defects are severe and can significantly affect a child’s quality of life in the future. Children born with a cleft lip or cleft palate may suffer from serious feeding difficulties caused by food and liquids passing from the mouth back through the nose. Affected children are also more prone to having fluid build up in their ears, which can lead to frequent ear infections and even hearing loss. Other complications associated with potential Topamax cleft lips or cleft palates include dental problems like missing or misaligned teeth, and developmental problems like speech and language delays. Children struggling with cleft lip or cleft palate require surgery in order the correct the malformation, often followed by long-term care in order to monitor the child’s development and prevent further problems.

Topamax Attorneys for Cleft Palate and Cleft Lip Birth Defects

According to the FDA, approximately 32.3 million Topamax prescriptions were filled between January 2007 and December 2010, with an additional 4.3 million Topamax prescriptions filled by patients utilizing outpatient retail pharmacies in the United States. Unfortunately, according to this new information provided by the NAAED Pregnancy Registry, and supported by other medical studies, the use of Topamax and other antiepileptic drugs during pregnancy may be linked to an increased risk of serious birth defects like cleft palate and cleft lip. In fact, the FDA has advised physicians to avoid prescribing Topamax (topiramate) to women of childbearing age, especially when the drug is considered for a condition not typically associated with permanent injury or death.

If you took Topamax while pregnant and subsequently gave birth to an infant with a cleft palate or cleft lip birth defect, your child may be entitled to lifetime medical care. The FDA has developed a questions and answers document for patients and healthcare providers, regarding the risk of oral clefts in infants whose mothers took Topamax during pregnancy. Women who believe their child has been affected by a Topamax birth defect should contact a Topamax lawyer to discuss their legal options. By seeking financial compensation for the alleged Topamax injuries sustained by their child, families can make sure their loved ones receive adequate medical care now and in the future.

Posted Under: FDA - Food and Drug Administration
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