Topamax Lawsuit
Topamax (topiramate) is an anti-seizure medication produced by Ortho-McNeil Neurologics and Normaco Inc., both divisions of Johnson & Johnson. On March 4 2011, the Food and Drug Administration stated that Topamax (generic: topiramate) had been linked to oral clefts in newborns who’s mothers took the drug during pregnancy.
The FDA designated Topiramate as a Pregnancy Category C drug because the data from animal studies suggested the possibility of fetal risks. Based on more recent data, Topiramate labels are now being updated with new information and warnings highlighting the increased risk of oral clefts.
Topamax Cleft Palate Lawsuit
Cleft palates also known as Cleft Lips or Harelips occur when the two parts of the lip or palate do not completely fuse together. The results range from a small indentation in the lip to a groove that runs into the roof of the mouth and nose, potentially causing problems with eating, talking, ear infections, and other complications. Surgery often is performed to close the lip and palate and most children do well after treatment. However some potential risks include:
- Adverse reactions to anesthesia and other medications
- Abnormal connection between the mouth and nose
- Bleeding
- Breathing issues
- Infection
- Incorrect growth of bones in the middle of the face
Cleft palate birth injuries are series. When taking this drug the likelihood of giving birth to a child with an oral cleft is 1.4% as compared to only .07% for mothers who are not taking an anti-seizure medication. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry showed an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Similar research from the United Kingdom Epilepsy and Pregnancy Register supported the North American Antiepileptic Drug (AED) Pregnancy Registry findings.
Contact Our Topamax Lawyers Today
Before prescribing Topiramate, physicians and health care professionals should warn patients of childbearing age about the potential risks to the fetus if a woman becomes pregnant while using the drug for certain types of seizures.
What if your baby was born with a cleft palate or cleft lip? Do you have a Topamax birth defect lawsuit? Do not hesitate to contact the Potts law firm to discover your legal options regarding unsafe drugs prescribed to you during your pregnancy.
