Johnson & Johnson subsidiary Ortho-McNeil might be facing Topamax lawsuits for its alleged failure in issuing an early warning regarding the anticonvulsant’s potential to cause birth defects. Despite studies suggesting that mothers who take Topamax during pregnancy are exposing their infants to the risk of developing birth defects started cropping up in 2008, Ortho-McNeil chose to remain silent about it until its attention was called this year. As if the Topamax problem is not enough, Ortho-McNeil division Janssen has reported shortages of cancer treatment drug.

Ortho-McNeil began distributing Topamax in 1996 after it received the stamp of approval from the US Food and Drug Administration (FDA) for epilepsy treatment. FDA added an indication for the prevention of certain types of migraine headaches for the anticonvulsant in 2004. Topamax has become one of the most frequently prescribed antiepileptic drugs in the US market since its introduction.   

The first information reported about Topamax’s link to birth defects was a study pertaining to it which was published in the Neurology journal in the United Kingdom in 2008. The data provided by the UK Epilepsy and Pregnancy Register was used as basis for the study which determined that infants born to women who take Topamax during pregnancy have an increased risk of being born with serious birth defects like cleft lip, cleft palate and hypospadias. Similar findings were reported by the North American Antiepileptic Drug (NAAED) Pregnancy Registry in 2010.

Despite these findings from legitimate agencies, Ortho-McNeil allegedly never issued any warning about the pregnancy risks until the FDA published warnings about the dangers of Topamax use in pregnancy early this year. The FDA also elevated the pregnancy category of Topamax from C to D, meaning there is positive human evidence of the drug’s potential to cause serious harm to a fetus when taken during pregnancy after reviewing the registry’s data. 

Ortho-McNeil was made to pay a fine of $6.1 million for illegally marketing Topamax as a treatment for psychiatric conditions so this is not the first time that the pharmaceutical got into trouble with Topamax. Mothers who might have taken the drug in the last 15 years, and who have given birth to infants with birth defects could seek compensation for medical expenses and other damages incurred as a result of the birth defect through a Topamax lawsuit.