Popular Prescription Epilepsy Drug Causes Concern Over Birth Defects Children born with birth defects enter this life facing tremendous challenges, primarily when the birth defects affect the child’s appearance. One out of every 594 babies are born with a cleft lip or palate. The total equates to approximately 6,800 children each year born in […]
Children born with birth defects enter this life facing tremendous challenges, primarily when the birth defects affect the child’s appearance. One out of every 594 babies are born with a cleft lip or palate. The total equates to approximately 6,800 children each year born in the United States with a cleft lip or palate. Consequently, cleft lips and palate are the most common birth defect newborns face in the U.S.
Every parent desires their child to be born healthy. Giving birth to a child born with a cleft lip or palate exponentially adds to the stress new parents experience. Additionally, the baby will require reconstructive surgery to bridge the gap that did not occur naturally. This fact causes even greater stress and worry, not to mention piling up medical bills and lost wages for the parents who must take time out of work to tend to their son or daughter who has to undergo surgery to repair their cleft lip or cleft palate.
No one knows why children are born with a mouth that did not completely grow while the baby was in the womb. Doctors do not understand what happens. However, newly emerging evidence suggests that at least one frequently prescribed medication called topiramate, whose generic name is Topamax, might be responsible for some of the children born with cleft palates or cleft lips. Topiramate is an anti-seizure medication, but the drug is used to treat other medical conditions when used in lower doses. Researchers have made a correlation between a mother taking topiramate in her baby’s first trimester and a cleft lip and palate. It is no coincidence that the palate and lip of the child form within the first three months after conception.
The birth defect lawyers with Parker Waichman LLP understand your pain, anguish, frustration, sense of worry, and also a sense of betrayal. That is why our drug defect lawyers relentlessly pursue justice for you and your baby to hold those responsible for causing your child to be born with a birth defect. Parker Waichman’s birth defect attorneys will rely on their vast experience they accumulated filing legal claims against large, international pharmaceutical companies and winning verdicts or reaching settlements on their clients’ behalf.
To date, Parker Waichman LLP has recovered over $2 billion in damages for their client. You and your family can count on Parker Waichman’s experience, skill, and unparalleled resources to help you achieve a substantial monetary settlement for your Topiramate birth defect claim.
Findings from a study released in late December of 2017 indicate that women who take 100 mg of topiramate for reasons other than to control epilepsy in their first trimester increased the risk of the child being born with a cleft lip or palate by 50%. However, women with epilepsy who take the prescribed dose of 200 mg are at an even higher risk of having a child born with a cleft problem.
The results of the study were significant. Researchers found that 4.1 out of every 1,000 children born to mothers taking topiramate were born with a cleft lip or palate. Conversely, 1.1 out of every 1,000 children born to mothers who did not take anti-seizure medication had a cleft problem and 1.4 children out of 1,000 were born with a cleft deformity to mothers taking other anti-seizure medicines.
These figures are significantly higher than the data released by the U.S. Food and Drug Administration (FDA) in 2011. At that time, the FDA issued a warning about the dangers pregnant women could encounter from taking topiramate.
A cleft lip and cleft palate are related medical conditions. A child had a cleft lip when the left and right side of the top lip did not attach in the womb. Similarly, a cleft palate is similar in that the right and left side of the child’s mouth did not grow together. The lips and palate fuses or grows together during the first three months of gestation. The fusion process creates those two vertical lines that appear to connect to the bottom of the nose as well as the line that runs down the center of the roof of the mouth.
Parents of children born with a cleft problem worry that their child may not develop as a “normal” child otherwise would. One of the most visible issues is whether the child will be able to nurse or take a bottle because of the cleft problem. The baby may or may not have a problem taking food. Medical experts seem to think that feeding problems are dealt with on an individual basis. Similarly, parents worry about whether their baby’s teeth will grow correctly. The prevailing opinion is that the baby’s teeth will be fine as long as the cleft did not involve the gums. The child will need specialized dental care when the time comes if the cleft palate involved part of the upper gum.
Parents have other concerns the go beyond the appearance of their child. Many parents of cleft babies question whether the child will enjoy normal psychological and intellectual development. Doctors opine that the child should develop naturally without impediment unless the cleft problem is related to a syndrome.
Another deeply held concern is whether the child can develop a speech impediment. The chances are better for typical speech development for a child with a cleft lip. However, a child with a cleft palate will require speech therapy and even additional surgeries so that the baby has an opportunity to learn to speak later in life. Pediatricians usually include speech therapists as part of the baby’s treatment team as the child matures to the point that the child should begin to talk. The stated goal is to intervene as soon as possible, so the child has an excellent opportunity to develop a healthy speech pattern.
Lost in all of the concerns about the child are the concerns for the parent. Depression, anxiety, and despair are common emotions experienced by parents whose children were born with a cleft lip or palate. There is nothing abnormal about those emotions.
The health of the newborn is the most pressing concern for the parents, and they might disregard the stress they are under from the tremendous responsibility they have to care for a child suffering from a birth defect. Telling other family members about the baby’s physical ailment can be very stressful. Naturally, concerned family members will have a battery of questions and voice concerns, all of which are normal but can easily overwhelm a parent. Without proper treatment for these emotional problems at an early stage, they could become worse over time and affect other aspects of the parents’ lives.
Janssen Pharmaceuticals, the makers of topiramate, have a duty to warn their patients about the possible side effects of their drugs. Janssen has failed to warn of the significant risk for a child to be born to a mother taking topiramate. Proving that Janssen is liable in court is much more complicated than one might believe. Proving a pharmaceutical company is responsible for damages for failing to warn about the possible risks of taking their medication requires complex scientific evidence and testimony from experts. Also, Janssen Pharmaceuticals is a profitable international company who has a phalanx of lawyers at their disposal. That means you need the right lawyers who are skillful, knowledgeable, and not afraid of taking on drug companies like Janssen.
Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) or use our contact form to schedule a free, no-obligation consultation. We promise to fight for your child and you, so you can stop worrying about the financial responsibility with which you have been unjustly saddled and take care of your family. Call today because law strictly limits the time to file a claim.
Sources:
https://www.upi.com/Widely-used-epilepsy-drug-may-raise-risk-for-birth-defects/5621514408947/
http://www.cleftline.org/parents-individuals/frequently-asked-questions/
https://www.recallreport.org/side-effects/topamax
https://www.fda.gov/Drugs/DrugSafety/ucm245085.htm
