Topamax Lawsuit Birth Defects
Helping families affected by Topamax birth defects involving a cleft palate after taking this epilepsy drug during pregnancy and representing individuals who have developed heart, cranial and abdominal birth defects in filing Topamax lawsuits. 2011 cases are being filed individually and no nationwide Topamax class action lawsuithas been filed. On April 14th, 2011 the pharmaceutical manufacturer Ortho-McNeil-Janssen announced a Topamax recall which covered two lots of 100 mg tablets due to consumer reports of an unusual odor.
It has increasingly been reported that the drug Topamax (also referred to by the generic name Topiramate) which is prescribed to treat epilepsy has been linked to serious birth defects involving cleft palate and cleft lip. Many women of childbearing age have taken this medication which was first approved by the FDA for epilepsy treatment and later approved for treating migraines.
These medications, which include Topamax and Topiramate, have serious side effects for the unborn fetus associated with them including the increase risk of developing a cleft palate and cleft lip. The precise degree of risk of Topamax side effects involving birth defects is currently unknown; however the risk of complications has been reported in babies following use of these drugs. Women using Topamax during their pregnancy can expose their baby to the medication while in the womb.
Topamax And Pregnancy Birth Defects May Include:
• Cleft Palate
• Cleft Lip
• PPHN (persistent pulmonary hypertension)
• Abdominal Birth Defects
• Heart Birth Defects
• Cranial Birth Defects
Recently the FDA announced a warning regarding the use of Topamax during the first trimester of pregnancy. The warning stated that there was new data showing evidence of an increased risk for the development of cleft lip and cleft palate (oral clefts) in infants born to women who used Topamax (Topiramate) during pregnancy. Physicians are recommended to consider alternative medications that have a lower risk of oral clefts and other birth defects should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant. Cleft lip and cleft palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking and ear infections. Surgery is often used to close the lip and palate.
Topamax was previously classified by the Food and Drug Administration as a Pregnancy Category C drug, which means that data from animal studies suggested potential Topamax side effects for the fetus, but no adequate data from human clinical trials or studies were available at the time of FDA approval. However, because of recent human data that reveal an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but any potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite Topamax cleft palate risks.
In 2010, Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals (subsidiaries of Johnson & Johnson) agreed to pay more than $81 million dollars in fines related to the illegal promotion of Topamax related to unapproved or “off-label” psychiatric use.
Topamax Lawsuit Settlements
If your child has suffered from Topamax cleft palate birth defects please contact us for a free no-obligation consultation. We are currently investigating cases for families involving Topamax side effects that occurred after using this drug during pregnancy. For the latest news and updates and information on filing a Topamax lawsuit birth defects claim please call or e-mail us today.
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