On June 23, 2011, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case is Pliva v. Mesing. Writing for the Court, Justice Thomas noted that if Mesing and Demahy

Is Topamax Safe To Take While Pregnant? Breaking News! – Topiramate (Topamax®) Increases Risk of Birth Defects The American Headache Society (AHS) issued an alert to women of childbearing age to carefully weigh the risks and benefits of Topamax (topiramate) when choosing treatment. AHS also wants women of childbearing age to be informed of the interaction between Topamax and the reduced efficacy of oral contraceptives that contain estrogen (combination oral contraceptives, levonorgestrel implant/Norplant®, etonogestrel implant/Implanon®,

On March 7, 2011, the University of Utah, Department of Pharmacy, Drug Information Service issued a health care alert regarding the use of Topamax (Topiramate) by pregnant women during at least the first trimester of pregnancy. The alert is based on information from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Cleft lip or palate has occurred in 1.4% of infants exposed to topiramate in the first trimester of pregnancy. The frequency of oral cleft

On March 4, 2011, the FDA notified healthcare professionals and patients of an increase risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the