Lawsuits are expected to be filed against Johnson & Johnson subsidiary Ortho-McNeil with the US Food and Drug Administration (FDA) increasing the warning on the packaging of its anticonvulsant drug Topamax. According to several studies, there is an increased risk of birth defects to develop among infants whose mothers took Topamax during their pregnancy. Despite the serious risk, epileptic patients may have long to wait for another drug after the
possible Topamax alternative hits a snag with the FDA.
Topamax, which contains the active ingredient Topiramate, has been widely used for the treatment of epilepsy since its approval by the FDA in 1996. It was also indicated by the FDA to prevent certain types of migraine headaches in 2004. About 4.3 million patients filled prescriptions for the drug between 2007 and 2010.
Until studies first reported in the United Kingdom in 2008 suggested that Topamax increases the risk of infants developing birth defects, Topamax has been considered as an effective treatment for epilepsy and the prevention of migraine headaches despite the occurrence of minor side effects. In comparison to other antiepileptic drugs, Topamax had been found to have a higher birth defect rate with the data indicating that other antiepileptic drugs had a birth defect rate somewhere between 0.38 percent and 0.5 percent. Furthermore, newborns of mothers who didn't exhibit epilepsy or take antiepilepsy drugs demonstrate a rate of 0.07 percent indicating that infants whose mothers took Topamax are 21 times more likely to have Topamax birth defects, than normal. Included Topamax birth defects are:
* cleft palate
* cleft lip
* heart defects
* lung defects
* brain defects
* arm and limb defects
A new data from the North American Antiepileptic Drug Pregnancy Registry showed that 1.4 percent of infants exposed to Topamax while inside their mothers wombs developed oral clefts as compared to .38 to .55 percent of infants exposed to other antiepileptic medications made oral clefts as the most prominent among the birth defects. The risk of cleft lips and cleft palates was much lower at .07 percent when the mother was not taking anti-seizure medication during pregnancy.
Leading to difficulties in eating and talking, oral cleft defects occur when parts of the mouth do not completely fuse together and would entail corrective surgery for a child to lead a normal life. With the new data, expected to pile up against Johnson & Johnson and its subsidiary Ortho-McNeil are cleft palate lawsuits which would provide affected families with the opportunity to seek compensation.
