Mothers who have been taking the anticonvulsant Topamax in the last 15 years and gave birth to infants with birth defects could seek compensation through a birth defects lawsuit. Topamax was first marketed by Ortho-McNeil, a subsidiary of Johnson & Johnson, 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 Hyperammonemia with concomitant valproic acid 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. It was this side effect that had the FDA issuing a warning last March on the anticonvulsant’s potential to cause harm among infants of mothers who are taking Topamax during their pregnancy. From pregnancy category C, the drug was also reclassified by the FDA to D.
The birth defects lawsuit could bank on the fact that Ortho-McNeil failed to issue an early warning that taking Topamax during pregnancy increases the risk of infants developing birth defects. Ortho-McNeil had chosen not to act when studies linking the drug to birth defects were reported starting 2008, and had waited until its attention was called by the FDA early this year to include birth defects in the safety warning label on its packaging.
Topamax, which contains the active ingredient Topiramate, is one of the most prescribed drugs for epilepsy. About 4.3 million patients filled prescriptions for the drug between 2007 and 2010. One could just speculate at how many of these patients continued taking the anticonvulsant during their pregnancy thinking it was safe to do so in the absence of a warning from the drug manufacturer. The birth defects in association with Topamax according to the studies are:
* Arm and limb defects
* brain defects
* cleft lip
* cleft palate
* heart defects
* lung defects
The studies further suggested that among the birth defects, the infants are most likely to develop the oral clefts. When a child’s oral structures fail to develop properly in utero, that is when cleft lip and cleft palates occur. 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.
For a chance at a normal life, a child born with oral cleft might probably need to undergo corrective surgery. An opportunity would be provided by the birth defects lawsuit for families who want to seek compensation for medical bills and other damages resulting from the birth defect.
Tags: Health and Fitness