Topamax lawsuits are expected to be on the rise with affected families urged not to let its manufacturer Ortho-McNeil, a Johnson & Johnson subsidiary, get away with not issuing an early warning about the birth defects linked to the anticonvulsant. Johnson & Johnson had pleaded guilty to promoting Topamax for unapproved uses last year and paid a fine of $81.5 million, so it will not be the first time should the lawsuits reach the court. As
Ortho-McNeil faces charges of illegal marketing practices for another drug, Topamax may be the least of Johnson & Johnsons problems.
For issuing a warning on the drugs potential for fetal risk only March this year, roughly 15 years after Ortho-McNeil began marketing Topamax for epilepsy treatment, Topamax lawsuits could hinge on this fact. More than 32 million Topamax prescriptions have been filled since 2007 as per FDA data. In the 15 years that the anticonvulsant was listed as a Pregnancy Category C medication, millions of women, unfortunately, may have taken Topamax during pregnancy without knowing the associated risks.
The classification of Topamax was elevated to Pregnancy Catgeory D by the US Food and Drug Administration (FDA) meaning there is positive human evidence of the drugs potential to cause serious harm to a fetus when taken during pregnancy. The classification was changed prompted by several studies suggesting that pregnant women undergoing Topamax treatment is exposing their infants to the risk of developing birth defects such as:
* cleft palate
* cleft lip
* heart defects
* lung defects
* brain defects
* arm and limb defects
The FDA said the finding is supported by similar data from the United Kingdom Epilepsy and Pregnancy Register which was published in 2008 in the journal Neurology and prompted the studies in the US. Ortho-McNeil and Johnson& Johnson waited for FDA promptings only this year to update the warning label on the Topamax packaging to include the birth defects risk, instead of taking notice immediately. To cover medical expenses, pain and suffering resulting from medication-related birth defects, patients who have taken Topamax during pregnancy may be eligible to receive compensation via a birth defects lawsuit or a Topamax lawsuit.
