Topamax is a prescription anticonvulsant medication currently manufactured by Johnson & Johnson. The drug was approved by the FDA in 1996 for the treatment of partial onset seizures and tonic-clonic seizures associated with epilepsy, and an indication was added in 2004 for the prevention of migraine headaches. The active ingredient in Topamax is topiramate, and the drug is used by itself as monotherapy or in combination with other anticonvulsant drugs to slow down certain impulses in the brain which are responsible for causing seizure-related episodes. Because epilepsy and even migraine headaches affect millions of people in the United States alone, anticonvulsant medications like Topamax have become increasingly popular in recent years. Unfortunately, recent Topamax side effect studies have indicated a potential connection between the use of Topamax during pregnancy and the development of major birth defects among infants exposed to the drug in utero. Among these defects is a craniofacial birth defect called cleft palate.
A cleft palate is a congenital birth defect affecting the formation of a child's palate, or roof of the mouth, in utero. During normal fetal development, the cells of the palate begin to fuse together after five weeks' gestation. However, when there isn't enough tissue in the palate area during this time, the roof of the mouth may fail to close completely in utero, resulting in an opening one one or both sides of the mouth. The severity of a cleft palate can range from a minor opening in the soft portion of the back of the mouth to a nearly complete separation of the roof of the mouth.
Children with cleft palate typically struggle with a number of difficulties associated with the condition, including feeding issues, chronic ear infections, hearing loss, missing or malformed teeth, and speech and language delay. The only way to permanently repair a cleft palate birth defect and correct the side effects linked to the condition is for the child to receive reconstructive surgery. There are also temporary solutions which can be employed in order to alleviate the symptoms of cleft palate before surgery can be performed. There are baby bottles specifically designed to keep liquids flowing downward which can be used during feeding, and there are also mad-made palates which can help a child eat properly. Tubes can also be inserted in the child's ears in order to drain the fluid which causes ear infections and hearing loss. Many children with cleft palate will require several surgeries in order to repair the malformation, followed by long-term dental care in order to prevent any further complications.
A study published in the journal Neurology in 2008 examined the adverse side effects of Topamax use during pregnancy on infants exposed to the drug in utero. According to researchers, infants whose mothers took Topamax while pregnant had a significantly increased risk of being born with serious birth defects like cleft palate, cleft lip and genital defects like hypospadias, compared to infants who were not exposed to the drug during pregnancy. Of the 178 births reviewed in the study, sixteen infants were born with birth defects, three of which were exposed to Topamax alone and thirteen of which were exposed to Topamax and another anticonvulsant drug in utero. Of the sixteen affected infants, four were born with cleft lip or cleft palate, a percentage eleven times what would be expected among unexposed infants, and four were born with genital defects like hypospadias, a rate fourteen times what would be expected among unexposed infants. Even more revealing, side effect researchers indicated that the birth defect rate was highest among infants exposed to Topamax in combination with valproate, the active ingredient in the anticonvulsant drug Depakote.
In addition to this side effect study, Topamax birth defect information was gathered by the North American Antiepileptic Drug Pregnancy Registry and reviewed by the FDA. The side effect data indicated that 1.4% of infants born to women who took Topamax during pregnancy were born with cleft lip or cleft palate, compared to the rate of defects among infants exposed to other anticonvulsant drugs in utero (0.38-0.55%), and the rate among infants not exposed to any anticonvulsants during pregnancy (0.07%). After this information was released, the FDA issued a safety announcement regarding the increased risk of craniofacial defects like cleft lip and cleft palate among infants exposed to Topamax in utero.
The FDA has increased Topamax's pregnancy category from C to D, which means there is positive human evidence of the drug's side effect potential to cause significant harm to a fetus when taken during pregnancy. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician as soon as possible. The FDA has advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of Topamax treatment justify the potential risks to the fetus. It may be dangerous to discontinue use of a prescription medication without medical consent, but with your doctor's help, you may be able to find a safer alternative to Topamax for treating your condition.
If you or a loved one has suffered from a birth defect like cleft palate and you believe the anticonvulsant drug, Topamax, to be the cause, contact a Topamax lawyer to discuss your legal options. You may have grounds to file a Topamax lawsuit or join a Topamax class action lawsuit against Johnson & Johnson in order to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering sustained by you and your family. Drug manufacturing companies are responsible for the safety of their medications and should be held liable for any adverse side effects sustained by consumers of their products. The only way to protect your rights and stand up to big drug companies is to hire a Topamax attorney to represent your case.
Following a birth defect diagnosis, the families of victims should be given time to concentrate on seeking medical care for their child without having to worry about developing a birth defect case as well. Defective drug litigation can be a complex process, but with the help of a qualified Topamax attorney, potential birth defect victims can feel confident that their Topamax lawsuit is in good hands.
Topiramate (Topamax) passes into breast milk, but its effects on developing babies are so far unknown. If you take Topamax, consult your physician to discuss the best way to feed your baby.
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Cleft palate birth defects, along with cleft lip and hypospadias, may be a result of Topamax side effects when taken during pregnancy. Victims of defective drug injuries may be entitled to lifetime care by filling a Topamax lawsuit or joing a class action against Topamax.