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All Topamax lawsuits filed in Pennsylvania state court by families who claim that use of the epilepsy and migraine medication during pregnancy caused their children to be born with severe birth defects, are centralized in Philadelphia for pretrial proceedings.
The complaints all involve similar allegations that Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson, failed to properly research the pregnancy risks associated with their medication or adequately warn about the risk of birth defects from Topamax, such as cleft lip, cleft palate, genital malformations and other problems.
The Pennsylvania state court litigation was centralized in the Philadelphia Court of Common Pleas on September 16.
Topamax (generic topiramate) was approved by the FDA in 2004 for the treatment of epilepsy and later was also approved to treat migraines. It became available as a generic in 2006.
In March 2011, the FDA issued a warning that Topamax side effects may increase the risk of oral cleft birth defects, such as cleft lip and cleft palate, among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.
Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.
Although only a small number of cases have been filed so far, several Topamax birth defect lawyers are investigating and reviewing potential claims for children born with birth malformations or defects after the mother was given the medication during pregnancy.