Topamax is an anti-convulsant used to treat seizures in adults and children over the age of 10. It is also used to treat migraines. The drug is not used to stop a migraine headache or seizure that is already in progress, but to prevent either one from happening. The drug has been approved by the FDA only for these two purposes, but has been used by doctors to treat other conditions. Legal action was taken, and the pharmaceutical company responsible for this was fined over six milliion dollars.
What Are Side Effects or Risks Associated with Topamax?
Topamax is associated with a few side effects and risks, some more dangerous than others. The most common side effect associated with the drug is numbness and tingling (parasthesia) in arms and legs. Other side effects include fatigue, change in tastes, weight loss, difficulty focusing, short term/non-severe loss of memory, nausea, loss of appetite, and diarrhea. No side effects seem to be long-term or life threatening.
Recently, the FDA announced a change in the drugs pregnancy classification from Class C to Class D. Data has shown that women who take the drug during at least the first trimester of pregnancy expose their fetuses to the risk of developing a cleft lip or cleft palate. Other birth defects have been reported as a result of Topamax use, but not at the same frequency as the oral clefts and malformations.
The FDA has suggested that doctors not prescribe the drug to pregnant women, or women of childbearing age, if there is another, viable option for treatment. Only when there is no other choice for treatment should a pregnant woman be prescribed Topamax (topimirate).
Birth Defects Attorneys in New Jersey and Philadelphia
If your child was born with a cleft lip or cleft palate birth defect and you believe the defect was brought on by your use of Topamax during the pregnancy, you may be entitled to compensation from Johnson & Johnson and/or Ortho-McNeil, the companies responsible for manufacturing and marketing the drug. Contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Let our attorneys help your family earn your due compensation.
An infant’s face and skull form within the womb during the first trimester. Normally, the tissues that make up the hard palate (roof of the mouth) and the lip fuse together. When they do not, a hole or opening forms. This hole/opening is known as a cleft. 
A cleft lip can lead to extreme alterations of one’s life and can be difficult to cope with. If your newborn baby has a cleft lip or cleft palate, you will be bombarded with information from medical professionals across varying fields. These professionals will provide you with an abundance of helpful information, however, it is natural to feel overwhelmed. You need not panic as there are many other parents –like yourself—who are going through the same situation. Birth defects, such as 
Topamax was prescribed to millions of people who were excited about this “medical break through”. Unbeknownst to those taking the medication, Topamax has been found to increase the occurrence of birth defects in expectant mothers who take it. Five years after its release, in March 2011, the FDA forced Topamax to issue a warning about the correlation between their drug and birth defects. Five years of availability on the market means that countless expectant mothers have taken this pill, hoping to no longer suffer from epilepsy and seizures. The FDA’s website has confirmed that taking Topamax will increase fetal risk of birth defects, such as cleft lip or palate. The severity of this side effect must be taken into consideration when prescribing medication to expecting mothers. If you take Topamax and suspect that you could be pregnant, you should seek a medical professional to receive an expert opinion on the matter. There are alternative medications available that have not shown side effects of birth defects which are far safer to take during pregnancy.
Your doctor will take your personal circumstance into deep consideration and will advise you of the great benefits that are possible from surgery, along with the potential risks and side effects. The advantages of surgery are obvious in helping the child’s dentition, oral health, and your child’s ability to lead a “normal” life. However, when making this important decision, you, as the parent, need to be aware of the potentially harmful effects. 
Cleft lip occurs in about one out of seven hundred births, meaning there are people who are ready to help your child live a normal life. This team consists of professionals like a plastic/craniofacial surgeon, pediatrician, orthodontist, pediatric dentist, speech language pathologist, ear nose and throat specialist, an audiologist, genetic counselor, nurse team coordinator, and a social worker. Each of these individuals will provide a form of support and strength to your baby and family. These professionals are trained to treat your baby’s needs and answer any questions you may have. Beyond providing healthcare for your baby, counselors and social workers are designated to help your child cope with the psychological aspects that may accompany a cleft lip/palate. A child with a cleft lip will face many health problems, but the deeper, emotional problems can be just as significant. These counselors will introduce you to organizations for certain birth defects, as well as support groups of other families just like yours. Despite the fear of the unknown, it is crucial to be an advocate for your child and to utilize all possible resources.
Diagnostic screenings will be needed in order to avoid reactions from the medications that will be given to your new baby for the surgery. The first phase of the surgery is the anesthesia. The anesthesia will be administered to your baby to put him or her in a “sleep like coma” to avoid pain. The sedation can be given generally or intravenously, and will be chosen depending on your doctor’s recommendations. Next, an incision will be made on either side of the cleft. This flap will then be sewn together to close the cleft. If the incision is successful the surgery is complete and your baby will wake up when the sedation wears off. Once your child is awake, it is important to closely follow the surgeon’s suggestions on caring for the wound. Certain medications may be taken orally or applied directly to the incision to aid in preventing infection and strengthening the new formation. There will be specific feeding restrictions for your child which your doctor will suggest for you. Following surgery, you may find your baby restrained to keep him or her from touching the surgical site until it heals. This surgery is the first of the process to correct clefts, and depending on the outcome of this surgery and your child’s individual case, he or she may need to undergo follow up procedures for health or cosmetic reasons.
Most children with these birth defects require a first, initial surgery as early as 3 months. These surgeries are often invasive and require tedious work on behalf of the plastic surgeon. This initial surgery is crucial to preventing disease from forming in the exposed region of the cleft lip, and to providing a healthier dentition. This preliminary surgery helps restore the actual structure of the face. 
When a cleft does not affect the mouth’s palate structure it is referred to as cleft lip. Cleft lips can occur on one or both sides of the lip which are generally referred to as unilateral or bilateral clefts. The first category of cleft lip is known as an incomplete cleft. An incomplete, or partial, cleft lip occurs at the top of the lip. The cleft appears as a small gap or indentation that does not reach the nose.
Psychosocial problems are not a definite side effect of birth defects and generally, when children have their cleft lip operated upon soon after birth they will have a strong recovery and a healthy social life. The risk in adolescents is far greater when they suffer from birth defects and this may lead to self-esteem, social, and behavioral issues. As children grow older, dealing with a cleft lip may lead to issues relating to self concept, relationships with their peers, and worries with their appearance. During the preschool years, ages three through five, children who have a cleft lip or cleft palate tend to be on par with peers without any oral malformations with regards to self-concept. As children grow older however, they may feel increased pressure and face more social issues. As children have increased interaction with other kids, children who have clefts tend to have more dissatisfaction with relationships with peers and have an increased level of social anxiety. With age, children will generally experience increased social anxiety and pressures with regards to their cleft. These visible deformities may yield a stigma and it is best to have birth defects treated as soon as possible in order to limit the social issues children face as they age.