Common treatment of epilepsy and migraine headaches includes medications such as Topamax. Topamax, or Topiramate, is an anti-convulsant medication. Communication between the nerve cells relies on complex movements of electrically charged particles. Seizures and migraines occur when nerve cells collect and release too many particles, causing abnormal, excessive, or synchronous activity in the neurons. Topamax works by calming these excitable nerve cells, reducing the occurrence of seizures and migraines. Epilepsy and migraines are usually controlled, but not cured, with medication such as Topamax.
Even innocuous over-the-counter medications, such as ibuprofen or aspirin, are not recommended for use during pregnancy. If you have a health condition that requires regular medication, your doctor can evaluate whether it’s safe for you to remain on the drug. Before you take any medication — prescription or over the counter — talk to your doctor first.
As a general rule, it’s best to use caution and avoid use of any medications during pregnancy. Exposure to pharmaceuticals is accounts for 2-3 percent of birth defects. Some of the most dangerous drugs include the acne drug Accutane, the sleep aid/morning-sickness drug Thalidomide, and the psoriasis treatment Soriatane.
In addition, the anti-convulsant, Topamax, has recently been shown to cause severe congenital birth defects, such as cleft lip and cleft palate. Earlier this year, the Food & Drug Administration strengthened warnings regarding Topamax during pregnancy. If you took Topamax prenatally, and have a child with a birth defect, contact an attorney today to see if you qualify for a Topamax lawsuit.
FDA Topamax Warnings
The development and approval process for drugs is the Center for Drug Evaluation and Research (CDER), a division of the U.S. Food & Drug Administration. CDER evaluates all new drugs before they are sold, evaluating their efficacy, as well as ensure that their health benefits outweigh their known risks.
Drugs are first tested in laboratories and on animals to evaluate safety. Next, clinical trials are performed on people to determine whether the drug is safe, and to document any potential side effects. The pharmaceutical company will send the results of these tests to CDER for evaluation. If the drug is proven to be safe and effective, it will be approved.
Due to the dangers of clinical trials on pregnant women, many drugs lack information regarding the effects of taking the drug prenatally. For example, the anti-seizure and migraine drug, Topamax, was recently shown to cause serious birth defects in infants whose mothers took the drug while pregnant. In fact, women taking Topamax had an 11 times higher rate of congenital birth defects.
Due to this new data, the Food & Drug Administration recently increased the pregnancy warning of Topamax to Category D, meaning there is positive evidence of fetal risk. Though the warning has been updated, many children suffer Topamax birth defects due to this FDA-approved drug.
Thankfully, many parents are filing Topamax lawsuits to ensure that they obtain compensation for the defects caused by the drug. If you or someone you know took Topamax prenatally, and has a child with a cleft lip or cleft palate, you should contact an experienced Topamax attorney today to assist you with your claim.
Studies show that 64 percent of pregnant women use at least one prescription drug during pregnancy. However, with all prenatal drugs, doctors must weigh the potential benefits against the risk of possible fetal harm. Unfortunately, little information exists because of the ethical issues surrounding clinical trials on pregnant women.
Topamax Birth Defects
Many women may have taken the anti-convulsant, Topamax, for the prevention of seizures or migraine headaches. On March 4, 2011, the Food & Drug Administration increased the pregnancy warning of Topamax to Category D, meaning there is positive evidence of fetal risk. The previous designation was Category C because of lack of human data.
The new label states, “there may be an association between the use of Topamax during pregnancy and congenital malformations.” A 2008 study published in Neurology found that women who took Topamax prenatally had a higher rate of babies born with cleft lips, cleft palates, or other congenital defects. In fact, the rate of birth defects in women taking Topamax was 11 times higher than the normal rate.
Cleft lip and cleft palate are variations of a type of congenital deformity caused by abnormal facial development during gestation. A cleft is a fissure or opening–a gap. An older term for cleft lip is harelip.
Cleft lip and palate birth defects can increase the risk of ear infections and cause problems eating and communicating. A cleft lip or palate can be successfully treated with surgery, especially if conducted soon after birth or in early childhood.
According to a scientific study published by the American Academy of Neurology in April 2008, taking Topamax significantly increases the risk of cleft lip and palate birth defects. The published study reviewed 203 pregnancies. Overall, the rate of oral clefts observed was 11 times more prevalent than the normal rate.
Approximately 1 in 700 infants are born with a cleft lip and/or a cleft palate. Therefore, the normal rate of cleft palates is 0.0014 percent. However, according to this study, persons taking Topamax during pregnancy had a cleft palate rate of 0.0157 percent — 11 times the normal rate of congenital malformations.
Due to these and other serious side effects, the United States Food and Drug Administration (FDA) issued additional warnings for Topamax. The warning was raised to Pregnancy Category D, which means there is positive evidence of human fetal risk.
Topamax has serious side effects. Taken prenatally, it can significantly increase the risk of congenital birth defects. If you or someone you know took Topamax while pregnant and has a child with a birth defect, contact an experienced products liability attorney today to discuss your possible Topamax lawsuit.
Due to the insufficient pregnancy warnings, many women are filing Topamax lawsuits to seek compensation for their infant’s birth defects. If you took Topamax prenatally, you should contact an experienced Topamax attorney today to assist you in evaluating your claim.