Topamax (topiramate) and its generic versions are used to treat certain types of seizures for individuals with epilepsy as well as prevent migraine headaches. On March 4, 2011, the Food and Drug Administration (FDA) released data outlining an increased risk of cleft palate and cleft lip oral birth defects in babies of women who took Topamax. Parents of children with cleft palates or cleft lips whose mothers were taking Topamax deserve to know how this could have happened. Topamax attorneys will ensure that a family's specific situation is thoroughly evaluated to determine negligent parties. With the help of a Topamax lawyer, a family may be able to receive compensation for medical bills, surgery, treatment, pain and suffering, and other damages.
How Did My Baby Suffer Cleft Palate?
The FDA news release emphasizes the importance of healthcare professionals to weigh the benefits and risks of Topamax when prescribing the medication to women of childbearing age. Prior to the recent FDA warning, there was no concrete data from human clinical trials or studies before Topamax's approval. Because of this, Topamax was formerly classified as a Pregnancy Category C drug, indicating that data from animal studies suggested potential fetal risks. Now, with the North American Antiepileptic Drug (AED) Pregnancy Registry revealing data about the heightened risk of oral clefts in infants exposed to Topamax during the first trimester of pregnancy, Topamax has been placed in Pregnancy Category D. This indicates there is positive evidence of human fetal risk based on human data. However, the new labeling suggests that the possible benefits from use of the medication in pregnant women may outweigh the risks in some situations.
Do I Need A Topamax Attorney?
Healthcare professionals are responsible for informing patients about potential side effects or birth defects associated with a specific medication. If a healthcare professional fails to warn a patient about the potential side effects of Topamax or does not offer alternative antiepileptic medications, and a woman's baby suffers cleft palate as a consequence, the healthcare professional may be held legally accountable. If an alternative medication with a lower risk of oral clefts and other adverse birth defects could have been considered for a patient, but was not, either due to negligence, oversight, or miscommunication, a baby could suffer a preventable oral birth defect.
While most oral birth defects can be successfully treated through surgery and other forms of care, these procedures can be painful, emotional, and expensive. A parent or parents of a child born with cleft palate because of Topamax may want to contact a Topamax birth injury attorney to help send a message to drug manufacturers and healthcare professionals that negligence causing birth injury will not go unpunished.
At Anapol Schwartz, our legal team of over 30 attorneys has extensive experience successfully handling medical malpractice cases and pharmaceutical litigation. To learn more about your legal rights and options, call 866-735-2792 for a free consultation.