We recently wrote that anticonvulsant medication, <"http://www.yourlawyer.com/topics/overview/topamax-birth-defects-side-effects-clefts-lawsuit">Topamax (topiramate), was linked to the development of oral cleftsâ€”cleft lip and/or cleft palateâ€”in babies born to women who took the drug during early pregnancy. We also wrote that the U.S. Food & Drug Administration (FDA) said Topamax, previously classified as a Pregnancy Category C drug, will now be placed in Pregnancy Category D. Topamax is rapidly showing itself to be a far too risky drug for use in expectant mothers.
According to the FDA, the Pregnancy Category D designation means that there is positive evidence of human fetal risk based on human data, but the potential benefits of Topamax in pregnant women were believed to outweigh the risks in certain situations. The new classification also applies to generic forms of Topamax.
Topamax is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches.
According to AlterNet, the FDA just issued a warning that women taking Topamax are 20 times likelier to give birth to babies with oral clefts and three times likelier to develop facial anomalies. Last year, said AlterNet, Johnson & Johnson (J&J), maker of Topamax, agreed to pay a $6.1 million fine for illegal drug marketing of the medication for psychiatric conditions and paying physicians to call health care providers, in collaboration with sales staff, to speak at meetings and dinners. The marketing scheme was cooked up by J&J subsidiary Otho McNeil and was entitled, â€œDoctor-for-a-Day,â€ According to the AP, Topamax was bringing in a hefty $2 billion annually by 2006, which, ultimately, more than covered the $6.1 million fine, noted AlterNet.
Oral clefts are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate.
Healthcare providers have been advised by the FDA to inform women of childbearing age of the increased risk for oral clefts when Topamax is used in the first trimester of pregnancy, and to weigh the benefits and risks of Topamax when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. If they decide to prescribe Topamax to women of childbearing age, doctors should recommend use of effective contraception.
As far back as 2004, the FDA warned J&J its marketing minimized â€œserious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis,â€ a violation of the Federal Food, Drug and Cosmetic Act, said AlterNet. â€œThese materials raise serious public health concerns because they encourage the unsafe use of Topamax, including, particularly, in pediatric patients,â€ said FDA.
In 2006, the FDA warned that Topamax can cause a serious eye condition â€œcharacterized by acute myopia and secondary angle closure glaucoma,â€ which can lead to â€œpermanent loss of vision,â€ quoted AlterNet. In 2008, FDA warned patients on all antiepileptics should be â€œmonitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behaviorâ€; warning labels were mandated. Last year, the FDA rejected diet drug candidate, Qnexa, which includes Topamax and phentermine (the so-called â€œgoodâ€ drug in Fen Phen) because of emerging questions regarding Topamax, said AlterNet.