Topamax and Birth Defects
On Friday, February 4th 2011, the Food and Dug Administration issued a warning against pregnant women and women of child-bearing age taking the epilepsy and migraine drug Topamax, also sold under the generic name of topiramate. The FDA warned that Topamax can increase the risks of birth defects in and around the mouth of the child. Topomax will now have to carry a stronger warning label that informs pregnant and potentially pregnant women of the risk of potential birth defects.
Topamax-related birth defects can include abnormal development in and around the area of the mouth, including the risk of cleft lift and cleft palate. Women who had taken Topamax or topiramate during the first trimester of pregnancy had a risk of delivering children with oral birth defects at a rate that was more than three times greater than women taking other seizure medications.
About Topamax and Topiramate
Topomax and its generic form topiramate are prescribed to treat seizures in people who have epilepsy or to control seizures in individuals who have Lennox-Gastaut syndrome.
Topomax Birth Defects in the News
- FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)
- FDA: Risk of oral birth defects in children born to mothers taking topiramate
- FDA Warns of Birth Defects With Topamax
- FDA Warns of Birth Defects Tied to Epilepsy Drug
- FDA Strengthens Topamax Warning On Evidence Of Birth Defects
Topamax and topiramate are also used to prevent migraine headaches. Roughly 4.3 million patients were given prescriptions for Topamax between 2007 and 2010.
The drug is sold under the name of Topamax by Johnson & Johnson corporation, a company that has recently come under scrutiny for a series of recalls, safety and manufacturing problems related to its drugs and medical devices.
A generic form of the drug called topiramate is sold by Mylan, Teva and other manufacturers.
Topamax, Cleft Lip and Cleft Palate
Cleft lip, cleft palate and other oral birth defects are considered severe birth defects and can have a significant effect on the development of a child. Because of the malformation in the mouth caused by cleft lip and cleft palate, children born with these conditions often have trouble with feeding. Children born with oral birth defects often are unable to form sufficient pressure in their mouths to suckle properly, making it difficult for these children to receive sufficient nutrition. This can lead to developmental difficulties that can affect a child for a lifetime.
Cleft lip and cleft palate can require multiple surgeries to correct. Because a child born with a cleft is unable to imitate a parent’s speech or begin to properly form words, an oral birth defect can create significant delays in speech development, putting a child at a lifetime disadvantage.
The FDA Warning on Topamax
In an FDA warning on Topamax issued on February 4th, 2011 the federal regulatory agency warned that doctors should “carefully consider the benefits and risks of topiramate when prescribing it to women of child-bearing age," and that "Alternative medications that have a lower risk of birth defects should be considered."
The FDA raised the drug's pregnancy category to D, meaning that there is evidence the drug can harm a human fetus. The FDA may still move to place the the drug in category X, which means the drug should never be used by women who are or may become pregnant.
The severe nature of the birth defects caused by Topamax can lead to a developmental difficulty and a lifetime of issues for the child. Clefts may require multiple complex surgeries to correct, which can be both emotionally traumatic and financially devastating for an affected family. Parents of children who have been born with cleft lip, cleft palate or other birth defects as a result of taking Topamax or topiramate have a right to seek compensation for their child’s injuries, their expenses, and their pain and suffering.
If your family has been harmed by Topamax or topiramate, the law firm of Blizzard & Nabers will work with you to file a Topamax lawsuit. Our firm specializes in pharmaceutical law. For more than 25 years, our attorneys have successfully represented our clients and stood up for the rights of people harmed by pharmaceutical companies and dangerous drugs. We are a nationwide law firm serving clients from all over the country. We handle all Topamax-related injury cases on a contingency basis.
To learn more, or for a free case review from an experienced Topamax attorney, please contact us by email or call us at 1-800-349-0127.