Topamax - Cleft Palate - Consumer Justice Foundation

Topamax – Cleft Palate

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Topamax and Cleft Palate

Topamax falls into the category of anticonvulsant medication, drugs which were initially designed as a primary treatment method for individuals suffering from epilepsy. However, since the first anticonvulsant was introduced to the U.S. market, these medications have been approved for additional uses and are even being prescribed for off-label purposes, as healthcare providers see fit. For instance, Topamax was originally approved by the FDA in 1996 for the treatment of generalized tonic-clonic and partial onset seizures associated with epilepsy. In 2004, the FDA included an additional indication for the purpose of decreasing the frequency and intensity of migraine headaches. The active ingredient in Topamax is topiramate, and the drug is currently manufactured by Johnson & Johnson.

Topamax and other anticonvulsant drugs function by interfering with certain impulses in the brain which are responsible for causing seizures. These medications have become increasingly popular in recent years, with Topamax being one of the most commonly prescribed drugs of its kind. However, Topamax has become the subject of significant scrutiny in recent years as new studies have indicated a potential connection between Topamax use and the development of serious birth defects among infants exposed to the drugs in utero. Among these birth defects is a craniofacial defect called cleft palate.

Cleft Palate Described

Cleft palate is a congenital birth defect characterized by a malformed palate, or roof of the mouth. In children with a cleft palate, the roof of the mouth fails to close completely, caused by a lack of tissue in the palate area during the early stages of fetal development. A cleft palate can affect the bony front part of the mouth or the soft back part of the mouth, and can vary in degree from a minor hole at the back of the mouth to a large opening in the roof of the mouth.

Cleft Palate Treatment and Complications

Children with cleft palate typically struggle with a number of complications caused by the separation of the roof of the mouth. Among these problems are:

  • Frequent ear infections
  • Hearing loss
  • Difficulties during feeding
  • Speech and language delay
  • Missing or misaligned teeth

Although there are temporary solutions to alleviate the symptoms associated with cleft palate, including the use of a man-made palate to allow the child to eat properly, the only permanent treatment for this defect is reconstructive surgery. With treatment, affected children typically make a full recovery. However, some infants may require long-term care in order to repair any additional complications associated with the birth defect.

Topamax and Birth Defect Studies

The FDA recently elevated the pregnancy category of Topamax from C to D after reviewing new data concerning the drug’s potential to cause serious birth defects. The FDA assigns a category D to medications which positive human evidence has shown can cause significant, unreasonable harm to a fetus when taken during pregnancy. This decision was made based on data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry which determined that infants born to women who took Topamax while pregnant were twenty times more likely to be born with cleft palate or cleft lip, compared to infants whose mothers received no anticonvulsant treatment during pregnancy, and three to four times more likely to be born with one of these two defects than infants exposed to other anticonvulsant drugs. The prevalence of oral clefts was 1.4% among infants exposed to Topamax, 0.38-0.55% among infants exposed to other anticonvulsants, and 0.07% among unexposed infants.

The journal Neurology published a study in 2008 in which researchers sought to examine the adverse effects of Topamax use on infants exposed to the drug during pregnancy. The study involved 178 infants born to women who became pregnant while taking Topamax, sixteen of which were born with major birth defects. Of these sixteen mothers, three took Topamax alone while pregnant and thirteen took Topamax in combination with another anticonvulsant drug. Of the sixteen affected infants, four were born with cleft lip or cleft palate, a prevalence eleven times what would be expected among the general population, and four were born with genital defects like hypospadias, a rate fourteen times what would be expected among unexposed infants.

Topamax Use While Pregnant

If you are currently pregnant or planning to become pregnant and you are taking Topamax, consult your healthcare provider immediately. The FDA has advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. Women who take Topamax during pregnancy may significantly increase their chances of giving birth to a child with one or more serious birth defects. It is never encouraged 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.

Contact a Topamax Attorney for Help

Victims of serious injuries resulting from the use of a dangerous drug are not at fault and should not be held accountable for the consequences resulting from their injuries. Cleft palate is a serious birth defect, and affected children will require reconstructive surgery, sometimes followed by long-term medical care. Unfortunately, this may put a financial burden on a family already emotionally distressed by a birth defect diagnosis. If you or a loved one has suffered from a cleft palate and you believe Topamax to be the cause, contact a Topamax attorney to discuss the benefits of filing a Topamax lawsuit against Johnson & Johnson. The goal of Topamax lawsuits and potential Topamax class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family.

Pharmaceutical companies are responsible for the safety of their medications, even after they enter the market, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, many drug manufacturing companies operate in their own best interest, intentionally concealing the harmful nature of their medications in order to avoid negative consequences, such as a drug recall. This leaves consumers vulnerable to serious injuries and even death, simply by taking their prescription medications. The only way to protect your rights and stand up to big drug companies is to hire a qualified Topamax lawyer to represent your case.

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