Anti-Epileptic TOPAMAX Associated With Cleft Lip Birth Defect
On March 4, 2011, the FDA released a warning regarding the anti-epileptic drug TOPAMAX, or generically, TOPIMIRATE. The warning stated that the drug has been found, in multiple cases, to be associated with the development of cleft lips and palates in fetuses when the drug is taken during gestation.
The announcement also included the change of the drugs pregnancy class to Class D. This change illustrates that “there is positive evidence of human fetal risk based on human data…”
What is Topamax?
Topamax is a drug generally used to treat epilepsy and migraines. It works by affecting chemicals in the brain that send signals to the nerves. When the nerves in our brain become overexcited, the result is a severe headache (a migraine), or in worse cases, a seizure (as in epilepsy). The FDA approved Topamax as preventative treatment for migraines and epilepsy only.
In 2010, Ortho-McNeil, the pharmaceutical company responsible for marketing and distributing the drug (and a subsidiary of Johnson & Johnson), was fined $6.14 million dollars for marketing the drug as treatment for certain psychiatric disorders, despite a complete lack of testing to assure that the drug was safe for those uses. If your doctor prescribed you Topamax for a use other than migraines or seizures, discontinue your use and seek out a second medical opinion and an attorney.
Ortho-McNeil’s disregard for their limitations set forth by the Food and Drug Administration does not say much for the care they have for patients. Did they simply look over the fact that animal testing provided data that showed a potential fetal risk when the drug was used during pregnancy? And why can the FDA approve the use of a drug when there is insufficient human testing data available for review? It seems that the human testing was done when the drug began to be prescribed to civilians; patients seeking out relief of debilitating headaches and seizures.
I Used Topamax While I was Pregnant and My Child Was Born with a Cleft Lip/Palate. What Should I Do?
If your child was born with a cleft lip or cleft palate birth defect, and you believe that the defect could be attributed to your use of TOPAMAX during pregnancy, contact the Mininno Law Office for a free case evaluation. The defective product and dangerous drug attorneys at the Mininno Law Office, John Mininno and Jim Nixon, are here to answer any questions that you may have regarding your legal rights and your next step. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Epilepsy is a common, chronic neurological disorder characterized by seizures. About 50 million people worldwide suffer from the disease, which is generally controlled (not cured) with medication. However, over 30% of sufferers do not achieve total control over their seizures, even with medication. Epilepsy is most likely to occur in children, or adults over the age of 65, but can occur at anytime. Often, brain surgery or trauma are catalysts for the onset of epilepsy, but epilepsy is not necessarily a life-long syndrome.
For more information on Epilepsy, or if you are a sufferer looking for community support, visit Epilepsy.Com
Migraine headaches are severe headaches accompanied by nausea, vomiting, and sensitivity to light and sound. They often last anywhere from 4-72 hours and are 3x more common in women than in men. While propensity to suffer from migraines generally lessens during pregnancy, some women begin to suffer more during pregnancy.
For more information on Migraines, visit M.A.G.N.U.M., the National Migraine Association – a source of information and support for those who suffer from chronic migraines.
Information about Cleft Lip and Cleft Palate
- Birth Defects Attorneys Discuss Psychosocial Problems in Children - 2011-09-15
- Birth Defects Attorneys Reveal List of Anti-Convulsants Causing Birth Defects - 2011-09-29
- Birth Defects Attorneys: Study Links Topiramate to Oral Birth Defects - 2011-10-11
- Birth Defects Attorneys: Answering Questions about Surgical Scars - 2011-08-17
- Birth Defects Attorneys Talk About The Cost of a Topamax Lawsuit - 2011-08-15
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