Topamax is one of a group of prescription medications called anticonvulsants, which were initially developed as a form of treatment for individuals with epilepsy. In recent years though, these drugs have been indicated for additional uses, and have even been prescribed for off-label purposes when a physician deems it appropriate. Topamax was approved by the FDA in 1996 specifically for the treatment of partial onset and generalized tonic-clonic seizures associated with epilepsy. In 2004, the FDA added another indication, approving Topamax for the prevention of migraine headaches. The active ingredient in Topamax is topiramate, and the drug functions by slowing down certain impulses in the brain which are responsible for causing seizure-related episodes. Topamax is currently manufactured by Johnson & Johnson and has become one of the most popular forms of anticonvulsant drugs on the U.S. market.
Although Topamax has become increasingly popular over the past fifteen years, recent research has raised concerns about the safety of the drug, especially in treating pregnant women. According to some studies, women who take Topamax while pregnant may significantly increase their chances of giving birth to infants with serious birth defects, including cleft lip.
Cleft lip is a craniofacial malformation characterized by the failure of the child’s upper lip to fuse together completely in utero. During normal fetal development, the lip is fully formed by the fifth or sixth week of gestation. When there is a problem during this process however, a cleft lip may occur. A cleft lip is caused by an inadequate amount of cells in the lip area while this structure is forming. A cleft lip may affect one or both sides of the lip and can range in severity from a minor notch in the lip to a severe opening which may even extend up through the nose.
Infants born with a cleft lip often struggle with significant issues resulting from the defect. In cases where there is a large opening in the lip, the child may struggle with feeding difficulties caused by fluids passing from the mouth back through the nose. Children with a cleft lip are also more prone to having fluid build up in their ears, which can result in frequent ear infections and even hearing loss. Infants with this malformation typically have missing or malformed teeth, and may also experience speech and language delay because of the defect. The only way to correct a cleft lip is for the child to undergo reconstructive surgery. Once the child’s lip is repaired, the additional difficulties should also be alleviated. However, some children with this defect may require long term dental and orthodontic care in order to ensure normal development and correct any further issues.
In 2008, the journal Neurology published a revealing study which involved 178 infants born to women who took Topamax during pregnancy. According to the report, sixteen infants were born with major birth defects which included cleft lip, cleft palate, and genital defects like hypospadias. Of the sixteen infants, three mothers took Topamax alone as monotherapy while pregnant, and thirteen took Topamax in combination with other anticonvulsant drugs. Of the sixteen affected infants, four were born with cleft lip or cleft palate, a rate eleven times what would be expected among unexposed infants, and four were born with genital defects like hypospadias, a rate fourteen times that among unexposed infants. Researchers involved in the study also indicated that the birth defect rate was highest among infants exposed to Topamax in combination with valproate, or Depakote.
More recently, the North American Antiepileptic Drug (NAAED) Pregnancy Registry collected new Topamax birth defect data which was subsequently reviewed by the FDA. According to the registry, 1.4% of infants whose mothers took Topamax while pregnant were born with cleft lip or cleft palate, compared to the rate of 0.38-0.55% among infants exposed to other anticonvulsant drugs, and 0.07% of infants exposed to no anticonvulsants during pregnancy. These results indicate that infants born to women who took Topamax while pregnant were twenty times more likely to develop an oral cleft than unexposed infants, and three to four times more likely to develop cleft lip or cleft palate than infants exposed to other anticonvulsant drugs.
The FDA has elevated the pregnancy category of Topamax from C to D because of new NAAED pregnancy registry data concerning Topamax use during pregnancy and the development of birth defects. Category D is reserved for medications which positive human evidence has shown can cause serious 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. You should never stop taking a prescription medication without medical consent, as this may cause further harm. However, 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. With your doctor’s help, you may be able to find a safer way to treat your condition.
If you or a loved one has suffered from a cleft lip which you believe to be associated with the use of Topamax, contact a Topamax attorney as soon as possible. You are not at fault for any adverse side effects sustained during the proper use of a dangerous drug, and you may be entitled to reimbursement for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Topamax lawsuit. Children born with a cleft lip typically suffer from a number of debilitating complications, and may require multiple surgical procedures in order to correct the defect and relieve the accompanying symptoms. Unfortunately, this means that the victim’s family will likely incur medical expenses which may be overwhelming, especially after experiencing the physical and emotional distress of a birth defect diagnosis.
By filing a Topamax lawsuit or joining a potential Topamax class action lawsuit against Johnson & Johnson, victims of alleged Topamax birth defects can collect the compensation they deserve and also bring public attention to the potentially harmful nature of the drug. Although it is the responsibility of drug manufacturing companies to alert consumers of any adverse side effects associated with their products, many pharmaceutical companies fail to do so. This puts consumers unknowingly at risk of suffering life-altering injury, illness or even death, which could have been avoided had the appropriate steps been taken. By hiring an experienced Topamax lawyer, you can protect your rights, receive the reimbursement you are entitled to, and potentially prevent further defective drug injuries.