After receiving new data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, the FDA published a news release on March 4, 2011 about an increased risk of oral cleft birth defects in infants of mothers who took Topamax (topiramate) and its generic varieties. What makes the potential risks of Topamax so serious is that oral clefts occur early in pregnancy during the first trimester, which is when most women do not even know they are pregnant. Patients should not stop taking Topamax, even if pregnant, until discussing alternative medication to treat seizures or prevent migraine headaches with a healthcare professional. Immediately stopping Topamax consumption could cause serious problems and not treating epilepsy during pregnancy can put a mother and her baby in danger.
Who Is Liable For Topamax Oral Defects?
FDA drug warnings and updated medication labels help spread awareness about possible side effects and defects. But what about babies who have already suffered cleft palates or pregnant women who are currently taking Topamax? Alternative antiepileptic medications do exist and can be discussed as an option with a healthcare professional. It is the duty of medical professionals to inform women of childbearing age who suffer from epilepsy about the potential dangers of Topamax and possible medication alternatives.
As a result of the new Topamax cleft palate risks, the FDA will be reclassifying the drug as a Pregnancy Category D drug. This means that there is human data showing evidence of the drug presenting human fetal risk. However, the possible benefits of the medication may still outweigh the dangers in some cases. Before the NAAED Pregnancy Registry data was collected and distributed, the FDA approved Topamax and classified it as a Pregnancy Category C drug. This meant that information from animal studies indicated possible fetal dangers, but that no sufficient information from human clinical trials or studies was available.
Some parents may be wondering where the makers of Topamax, Ortho-McNeil-Janssen Pharmaceuticals, Inc., stand in all of this. How did they not know about the increased risk of cleft palate in infants exposed to the drug during the first trimester of pregnancy?
How Can I File A Topamax Lawsuit?
Topamax lawsuits can be pursued with the assistance of a skilled attorney with experience handling pharmaceutical litigation and medical malpractice cases. A successful Topamax lawsuit can help families hold negligent parties liable and obtain compensation for cleft palate surgery, medical expenses, pain and suffering, and other damages. A Topamax claim can also help prevent future infant oral birth defects by helping spread the word about the dangers of Topamax and ensuring that responsible parties do not act negligently again.
Topamax Cleft Palate
Oral clefts affect the formation of the upper lip and/or roof of the mouth. Children with oral cleft defects often have issues eating, talking, and/or with ear infections. During the first year of a child's life that has an oral birth injury, surgery is often conducted to fuse the lip and/or palate. While most cleft palate surgeries are successful, some potential risks include:
- Abnormal connection between the mouth and nose
- Adverse reactions to anesthesia and other medications
- Breathing issues
- Incorrect growth of bones in the middle of the face
There is no doubt that parents of children with cleft palates due to Topamax have a lot on their minds and want what is best for their children. While filing a Topamax lawsuit may not seem like it should be a priority, there is only a limited time to hold negligent parties legally responsible and seek compensation for your child's medical expenses, pain and suffering, and surgery. At Anapol Schwartz, our Topamax birth injury lawyers are part of a highly skilled legal team of over 30 attorneys. We handle each and every case with diligence and sensitivity. To learn more about how we can help, call 866-735-2792 for a free consultation.