Birth Defects Lawsuit, An Option For Topamax Victims To Seek Compensation
Mothers who gave birth to infants with birth defects could seek compensation through a birth defects lawsuit if they had taken the anticonvulsant Topamax in the last 15 years. A Johnson & Johnson subsidiary, Ortho-McNeil, first marketed Topamax in 1996 after it was approved by the US Food and Drug Administration (FDA) for the treatment of epilepsy. Recently, after studies linked it to birth defects, the drug’s side effects have been scrutinized. One Topamax side effect Hyperammonemia with concomitant valproic acid use with concomitant valproic acid use which could lead to brain damage or worse, death.
Considered as the most serious Topamax side effect are the birth defects; so Hyperammonemia is not the worst side effect there is. This side effect prompted the FDA to issue a warning last March on the anticonvulsant’s potential to cause harm among infants of mothers who are taking Topamax during their pregnancy. The drug was also reclassified by the FDA from pregnancy category C to D.
The fact that Ortho-McNeil failed to issue an early warning that taking Topamax during pregnancy increases the risk of infants developing birth defects could be used as basis for the birth defects lawsuit. Studies linking the drug to birth defects have been publicized since 2008, however, Ortho-McNeil chose to be silent about it until its attention was called by the FDA early this year to include birth defects in the safety warning label on its packaging.
One of the most prescribed antiepileptic drugs is Topamax, which contains the active ingredient Topiramate. About 4.3 million patients filled prescriptions for the drug between 2007 and 2010. How many of these patients could have continued taking the anticonvulsant during their pregnancy thinking it was safe to do so in the absence of a warning from the drug manufacturer. According to the studies, birth defects in association with Topamax are:
* cleft palate
* cleft lip
* Hypospadias
* heart defects
* lung defects
* brain defects
* arm and limb defects
The studies further suggested that among the birth defects, the infants are most likely to develop the oral clefts. Cleft lip and cleft palate occur when a child’s oral structures fail to develop properly in utero. Feeding difficulties, recurring ear infections, dental problems, hearing loss, and delays in speech and language development are the severe side effects that could be suffered by children born with cleft lip or cleft palate.
A corrective surgery is what a child born with oral cleft might probably need to have a chance at a normal life. The birth defects lawsuit could provide affected families an opportunity to seek compensation for medical bills and other damages resulting from the birth defect.