On Topamax Litigation…
First introduced in 1997, Topamax is a prescription medication designed to be used in the treatment of migraine headaches and for epilepsy in adults and children. Unfortunately, in recent years, the use of Topamax during pregnancy has been associated with a significantly higher risk of the development of birth defects. Birth defects seen in children of Topamax patients include cleft lips, cleft palates, and hypospadias. A cleft lip or palate occurs when the skull plates that form the roof of the mouth fail to fully fuse during fetal development, leaving a gap in the lip. Hypospadias is a genital defect which results in the improper placement of the urethra on the penile shaft.
According to research cited by the FDA, as many as 1.4% of children exposed to Topamax during pregnancy may develop a cleft lip or palate, compared to only .07% of children whose mothers did not take the drug during pregnancy. Studies in the U.K. have found the risk of hypospadias may be as much as 14 times higher for women who use Topamax during pregnancy.
Topamax and Off-Label Use
Even with the known risks of prescribing Topamax to individuals who need an effective epilepsy medication, Topamax has also been prescribed by many health care professionals for several “off-label” uses. When a physician prescribes a drug for an “off-label” use, it means they are prescribing it for a condition that the FDA has not approved it to be used for. The “off-label” uses Topamax has been prescribed for include the treatment of bipolar disorder, nerve pain, and for reducing alcohol cravings in alcoholics. Prescribing a medication for an off-label use is not illegal, but it is illegal for a pharmaceutical company to promote their medication for non-FDA approved uses. In 2010, Ortho-McNeil-Janssen Pharmaceuticals was ordered to pay 81 million dollars in fines for the illegal promotion of Topamax for off-label uses.
Complications of Cleft Palates
Cleft palates are the most frequently cited birth defects associated with the use of Topamax. Children who develop cleft palates may experience a number of medical and social consequences from their condition. These may include:
- Difficulty eating (especially for infants)
- Increased likelihood of ear infections and total hearing loss
- Speech problems
- Difficulties with socialization
Sadly, children who suffer from this side effect may face greater challenges than many of their peers.
Complications of Hypospadias
Hypospadias is also a potential health problem arising from the use of Topamax during pregnancy.
Children with hypospadias may experience a range of issues as a result of their condition, including:
- Difficulty urinating
- Impairments to procreation
- Erectile dysfunction
The good news is that both hypospadias and cleft palates can frequently be treated early in life with appropriate medical intervention, typically surgical repair. However, in severe cases, it may not be possible to fully correct these conditions.
Your Legal Options
Many people are taking legal action against pharmaceutical companies who manufacture drugs that cause severe birth defects, including the makers of Topamax. If your child has suffered from a birth defect that may have been caused by the use of Topamax during pregnancy, a Topamax lawsuit may be able to help you secure compensation for your child’s unnecessary suffering.