Contact The Driscoll Firm, LLC, at our toll-free phone number or through our online contact form to get straight answers from a caring and dedicated legal professional who understands what you are going through. You may also consult these sources: Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), U.S. Food and Drug Administration Topomax, Janssen Pharmaceuticals, Inc.
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If you were prescribed and took Topomax (topiramate) while you were pregnant, and your baby was born with a cleft lip or cleft palate, you should contact an experienced pharmaceutical injury lawyer as soon as possible. Drug manufacturers have an obligation to ensure that the products they put on the market are safe and effective and to provide adequate warning of any risks that the use of their products entails. The Driscoll Firm, LLC, would like to talk to you… Read More
The FDA issued a “Drug Safety Communication” regarding the risk of oral clefts in children born to mothers taking Topomax (topiramate) in March 2011. It outlined the risks and said women of childbearing age should use effective birth control while taking Topomax or discuss the use of Topomax with their doctors if they become pregnant or plan to become pregnant. The FDA said healthcare professionals should inform women of childbearing age of the increased risk for oral clefts when topiramate… Read More
Yes, additional potential side effects of taking Topomax (topiramate) include: Metabolic acidosis (an elevated level of acid in the blood that may cause brittle or soft bones or kidney stones, harm a pregnant woman’s baby or slow the rate of growth in children) Psychological problems such as confusion, attention issues, tiredness and sleepiness, depression or mood problems. Less serious but common side effects of Topomax include: Diarrhea Loss of appetite Nausea Nervousness Taste change Tingling and numbness (paresthesia) in the… Read More
According to the FDA, topiramate increases the risk of cleft lip or cleft palate (oral clefts) in the babies of pregnant women who take the drug. The North American Antiepileptic Drug (NAAED) Pregnancy Registry reported evidence of an increased risk of oral clefts in infants exposed to topiramate alone during the first trimester of pregnancy. The oral clefts occurred 1.4 percent of the time compared to a prevalence of 0.38 to 0.55 percent of the time in infants whose mothers… Read More
Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, makes and sells the original drug known as Topomax. Its headquarters are in Titusville, New Jersey. Janssen Pharmaceuticals makes drugs that are prescribed for attention deficit hyperactivity disorder (ADHD), general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurological conditions (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management and women’s health.
Topomax is the brand name of the anticonvulsant drug topiramate. It is sold as a tablet (pill) and prescribed alone or with other drugs to control certain types of epileptic seizures or to prevent migraine headaches. The FDA has approved it for these uses. The FDA says it has also been prescribed “off-label” for other conditions. From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were written in the U.S., the FDA says.
