La FDA revisa la descripción de los efectos secundarios para la salud mental de los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban (bupropión) para reflejar las conclusiones de estudio clínico

[12-16-2016] Según una revisión de la Administración de Alimentos y Medicamentos de Estados Unidos (FDA) de un estudio clínico amplio que exigimos realizar a las compañías farmacéuticas1, hemos determinado que el riesgo de efectos secundarios graves sobre el estado de ánimo, comportamiento o pensamiento con los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban…

FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings

[12-16-2016] Based on a U.S. Food and Drug Administration (FDA) review of a large clinical trial that we required the drug companies to conduct,1 we have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion)* is lower than previously suspected. The risk of…

FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women

FDA reviewed many published research studies, including both nonclinical and clinical data. Nonclinical Studies We reviewed published nonclinical studies showing that early exposure to anesthetic drugs can produce adverse neurotoxic effects in different species, including simple nematodes, rats, and nonhuman primates.1-20 The studies demonstrate that the use of anesthetic drugs during the period of rapid…

FDA Drug Safety Communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer

We systematically reviewed published epidemiological studies evaluating the risk of bladder cancer with pioglitazone use. Some studies found an increased risk of bladder cancer with pioglitazone use and others did not. The following studies are presented to illustrate the inconsistent findings among all reviewed studies. The manufacturer of pioglitazone, Takeda Pharmaceuticals, conducted a 10-year prospective…

Non-Inferiority Clinical Trials

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