Topamax Allegedly Causes Cleft Palate in Newborn

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.