Frequently Asked Questions for Our Topomax Birth Defects Lawyers
Topomax (topiramate) is prescribed to assist with certain types of epileptic seizure and to prevent migraine headaches. Unfortunately, the drug has been linked to the development of cleft lip and cleft palate in the children of women who took the drug while pregnant.
The U.S. Food and Drug Administration (FDA) has warned of the potential for birth defects among the children of expectant mothers who took Topomax. However, the FDA says the potential benefits of the drug may outweigh its risks.
The FDA says women should talk to their doctors about Topomax or alternative treatments, and it advises health care professionals to advise patients of the drug’s risks.
At The Driscoll Firm, LLC, our drug injury lawyers are investigating cases of birth defects in the children of women who were not properly warned about the risk of taking Topomax while pregnant.
Below are answers to frequently asked questions (FAQs) about Topomax to assist those who may have taken this potentially harmful drug.
If you have additional questions about Topomax or believe you may have a legal claim pertaining to your use of the drug, please complete our contact form or call our toll-free number. We are ready to answer your questions and advise you of your rights and options.
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.
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.
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 took other antiepileptic drugs. There was an oral cleft prevalence of 0.07 percent among infants born to mothers who did not have epilepsy and did not take an antiepileptic medication.
The UK Epilepsy and Pregnancy Register reported a similar increased prevalence of oral clefts (3.2 percent) among infants exposed to topiramate alone, or a 16-fold increase in risk compared to the risk in their background population (0.2 percent), the FDA says.
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:
- Loss of appetite
- Taste change
- Tingling and numbness (paresthesia) in the arms and legs
- Upper respiratory tract infection
- Weight loss.
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 is used in the first trimester of pregnancy. Doctors should weigh the benefits and risks of topiramate when prescribing it to women of childbearing age and consider alternatives or, if they prescribe Topomax, should explain that the North American Antiepileptic Drug (NAAED) Pregnancy Registry reported a risk of oral cleft in babies born to mothers who took Topomax.
The position of the FDA as of its March 2011 advisory is that the potential benefits from use of Topomax (topiramate) by pregnant women may be acceptable in certain situations despite the risks.
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 about the circumstances of your use of topiramate and its possible effect on your child. You may be eligible to file a legal claim to obtain compensation for your medical expenses as well as for the pain and suffering of you and your child.
Our lawyers do not charge for our initial meeting with you. We also will not charge for any legal work we do on your behalf afterward unless you secure a full and fair recovery.
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.