Topamax Allegedly Causes Cleft Palate in Newborn

This case involves a defective drug. The plaintiff was a thirty-seven-year-old female who suffered from migraine headaches. Her doctor prescribed Topamax (topiramate) to decrease and prevent the headaches. One year after being prescribed Topamax, the plaintiff became pregnant with her first child. She continued to take the medication throughout her pregnancy. Nine months later, when the plaintiff gave birth, her child was born with a cleft palate and hypospadia. She did not take any other medication, nor did she consume alcohol or smoke during her pregnancy. Additionally, the plaintiff was not warned by her doctor, or the drug’s labeling, regarding any risks of taking Topamax when pregnant.

Question(s) For Expert Witness

1. How are warnings for pharmaceuticals determined, and what procedures are in place to ensure that relevant parties are informed of any dangers?

Expert Witness Response

Generally speaking, pharmaceutical companies must warn about any known adverse side effects to taking their drug. Topamax is an anticonvulsant medication prescribed to treat symptoms associated with epilepsy, and was later approved for treatment of migraine headaches, as well. Pregnant females taking Topamax during their first trimester of pregnancy can raise the risk of severe birth defects. By adequately warning women and their doctors about the side effects of their drug, the pharmaceutical company gives patients and doctors the opportunity to choose a different form of treatment. It was generally known that infants who had been exposed to Topamax, prior to birth, had an increased risk of being born with an oral cleft. When such information is available to a pharmaceutical company, usually through testing, it must be disclosed to the public. Following extensive testing, any serious adverse effects or risks associated with the drug's use need to be disclosed to the relevant parties. This usually includes the FDA, patients, and the medical community. This is done through scientific publications that discuss the drug’s effects, in addition to any harmful effects the drug may cause. Furthermore, it is customary to have conferences which discuss both the good and the bad to alert the scientific community of the company’s drug.