Pregnancy and Topamax Birth Defects
In September, Topamax lawsuits pending in federal courts throughout the county, were consolidated in Pennsylvania. The lawsuits allege birth defects in children whose mothers took Topamax. This blog post discusses these suits. If you have an interest in discussing a potential Topamax lawsuit, call 800-553-8082 or get a free on-line consultation.
Topamax is an antiepileptic medication. It is often prescribed, off label, as a mood stabilizer for patients with bi-polar disorder. Topamax lawsuits claim that birth defects such as cleft lip, cleft palate, genital malformations and other birth defects in children were caused by their mothers taking Topamax (topiramate).
Topamax and topiramate (generic) are manufactured by several companies. The lawsuits allege that manufacturers failed to warn both the public and regulatory agencies about the potential for birth defects if used during pregnancy. To give you some idea of who the bad guys are in this story, consider this: Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay more than $81 million dollars in fines in 2010 for illegal promotion of Topamax related to off-label psychiatric use. The history is replete with the choice of profits over patients.
Earlier this year, the FDA issued a warning and required label changes to list oral clefts as a possible side effect of its use during pregnancy. Risk is highest if used during the first trimester of pregnancy. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry show that infants exposed to antiepileptic drugs have a 0.38 to 0.55% prevalence of oral clefts, however, those exposed to topiramate have a 1.4% prevalence of oral clefts, nearly 3-4 times higher than other anticonvulsants.
Cleft palate is a condition in which the infant has a gap on the roof of the mouth which interferes with the normal functioning of the mouth including chewing and talking. To correct the birth defect, surgery is required. Surgery is generally required between 6 and 12 months of age and can take several surgeries, and years, to correct.
Topamax was previously classified as a Pregnancy Category C drug, classified by the Food and Drug Administration. Category C drugs are those in which we have data from animal studies suggesting potential side effects for the fetus, however, adequate data from human clinical trials were not available or sufficient at the time of FDA approval. Due to recent human data demonstrating an increase in risk for oral clefts, Topamax and the generic forms are being reclassified as Pregnancy Category D drugs. This new classification means that there is strong evidence of human fetal risk, based on human data; however, the categorization also allows for use of the drug in pregnant women, as potential benefits may outweigh the risks in certain situations.
Some of the Topamax lawsuits include manufacturing defect claims, design defect claims, inadequate warning labels, and failure to adequately test. A claim that may be raised in lawsuits is that adequate human safety data, especially in pregnant women, was not thorough or publicized in order for women to make an informed decision before using the drug during pregnancy.
Topamax suits claim that there is little question that there is an increased risk of oral clefts in children whose mothers were exposed to Topamax during pregnancy. Topamax suits revolve around the idea that Johnson & Johnson/McNeil should have followed up on the animal data that was an obvious harbinger of the risks of Topamax, but that the problem was ignored because, again, profits reigned supreme over patient safety.
If you think you have a potential Topamax suit, and would like to speak with a lawyer, call 800-553-8082 or get a free on-line consultation.