Topamax Cleft Lip Lawsuit
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The U.S. Food and Drug Administration (FDA) recently warned that the anti-epilepsy drug Topamax® was responsible for causing cleft lips and palate in babies, when taken during pregnancy. The Topamax® birth defect risk makes it 20 times more likely to have a baby with an oral cleft than women who are not taking any anti-epilepsy medication.
The chances of an infant developing cleft lip are 4 times higher in Topamax® patients than any other epilepsy drug. If you were prescribed Topamax® during pregnancy and your child developed cleft lips and palate, we may be able to help you seek compensation.
While surgery can be used as a treatment, you and your family should not have to go through the emotional suffering caused by giving birth to a child with defects. A cleft lip lawsuit aims to hold the drug maker accountable.
Topamax® Birth Defect Risk
The FDA previously had Topamax® classified as a Category C drug, meaning animal studies had shown a potential risk to the fetus, but there was no human data. The new data has prompted the FDA to change the pregnancy category from C to D. Category D means there is evidence of human fetal risk, although in some cases the benefit to the mother might outweigh the risk.
Cleft lip and palate develop when the structures that form the lips and palate don't fuse together, leaving gaps. Newborn cleft lip develops very early in the pregnancy, between 5-6 weeks after conception, while the palate is formed about a week later. In many cases, the mother may not know she is pregnant this early. Because of this, the FDA advises healthcare providers to warn all women of the child bearing age of the potential dangers.
Oral Cleft Treatment
Children born with cleft lips and palate will usually require surgery to correct the problems. Even in surgeries that successfully correct the appearance of cleft lips and palate, the child may develop problems with:
- Feeding
- Hearing
- Speech
In addition, the social stigma can also necessitate counseling in addition to speech therapy.
Filing a Topamax® Lawsuit
Women who were unaware of the risk should speak with an attorney as soon as possible. Drug makers and healthcare providers can be considered negligent if they do not provide patients with the appropriate safety information. While a lawsuit may not reverse the damage, financial compensation can help ease the stress of the situation. Recoverable compensation can pay for medical bills as well as pain and suffering.
For more information, please contact a Topamax® cleft lip lawyer today.
