A birth defects lawsuit could be an option for mothers, who took the anticonvulsant Topamax in the last 15 years and gave birth to infants with birth defects, to seek compensation. 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. However, the drugs side effects have only been scrutinized recently after studies linked it to birth defects. Leading to brain damage or worse, death is the
Topamax side effect Hyperammonemia with concomitant valproic acid use.
However, Hyperammonemia is not the worst Topamax side effect there is as considered as the most serious so far are the birth defects. This side effect prompted the FDA to issue a warning last March on the anticonvulsants 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 birth defects lawsuit could use as basis 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 remained silent when studies linking the drug to birth defects started getting published in 2008, and only made a move when 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 drugs for epilepsy is Topamax, which contains the active ingredient Topiramate. About 4.3 million patients filled prescriptions for the drug between 2007 and 2010. Thinking it was safe to do so in the absence of a warning from the drug manufacturer, we could only speculate how many of these patients could have continued taking the anticonvulsant during their pregnancy. The birth defects in association with Topamax according to the studies are:
* Arm and limb defects
* brain defects
* cleft lip
* cleft palate
* heart defects
* Hypospadias
* lung defects
Oral clefts are the most likely to develop in infants among the birth defects suggested by the studies. 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 child born with oral cleft might probably need to undergo corrective surgery for a chance at a normal life. Affected families could seek compensation for medical bills and other damages resulting from the birth defect via the Topamax lawsuit.
