The discovery of the birth defects in association with Topamax had the anticonvulsants side effects list growing and getting attention despite its minority. One is
Topamax side effect Parasthesia characterized by tingling in the extremities, although it pales in comparison to the seriousness of the increased risk of an infant to birth defects. The public has been warned of a new data which suggested of an increased risk for the development of either a cleft lip or palate among children born to mothers who took Topamax or its generic Topiramate during their pregnancy by the US Food and Drug Administration (FDA).
Topamax, which has Topiramate as its active ingredient, has been approved by the FDA to be used either as a monotherapy or adjunctive therapy to treat epileptic seizures in 1996. Topamax, manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson, was also indicated to prevent certain types of migraine headache in 2004. However, studies, which started cropping up in 2008 in the United Kingdom, have suggested that infants, whose mothers were treated with Topamax during pregnancy, are at risk of being born with birth defects.
The North American Antiepileptic Drug Pregnancy Registry in a new data suggested 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. Their was a lower risk at .07 percent cleft lips and cleft palates when the mother was not taking anti-seizure medication during pregnancy.
Just imagine what it entails if you gave birth to an infant with Topamax cleft palates and cleft lips which typically require surgery and other related treatments if taking care of a normal baby is a full time job. Not only does it become a financial burden on the childs family, it also becomes an unpleasant life-changing event that parents may not be prepared for not to mention the burden that it also places on the child itself.
Despite the various studies linking Topamax to birth defects, Johnson & Johnson, has so far escaped responsibility with no birth defects lawsuit filed against its subsidiary Ortho-McNeil yet. Currently facing a shareholder lawsuit, Johnson & Johnson had attributed manufacturing quality failures at its McNeil consumer healthcare division to cuts, internal management tensions, frequent executive turnover and distractions caused by the integration of businesses acquired from Pfizer.
