Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de una reducción grave de la frecuencia cardiaca cuando se usa el medicamento antiarrítmico amiodarona junto con tratamientos contra la hepatitis C que contienen sofosbuvir (Harvoni o Sovaldi), en combinación con otro fármaco antivírico de acción directa

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que puede darse una reducción grave de la frecuencia cardiaca cuando el medicamento antiarrítmico amiodarona se toma junto con el fármaco contra la hepatitis C Harvoni (ledipasvir/sofosbuvir) o con Sovaldi (sofosbuvir), en combinación con otro antivírico de acción…

FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug

The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are…

FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)

The U.S. Food and Drug Administration (FDA) has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. We are unable to exclude the possibility that the deaths were caused by rapid,…

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA actualiza la etiqueta del medicamento para dejar de fumar Chantix (vareniclina), para incluir la posible interacción con el alcohol, un riesgo poco común de sufrir convulsiones, y los estudios de efectos secundarios en el estado de ánimo, la conducta o el pensamiento

Interacción con el alcoholLa FDA examinó la base de datos del Sistema de Denuncia de Efectos Adversos de la FDA (FAERS, por sus siglas en inglés) e identificó, desde que se aprobó el Chantix (vareniclina) en 2006, 48 casos de efectos adversos relacionados con una menor tolerancia al alcohol (n=11) o con una conducta agresiva…

FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking

Alcohol interactionFDA searched the FDA Adverse Event Reporting System (FAERS) database and identified, since the approval of Chantix (varenicline) in 2006, 48 cases of adverse events involving decreased tolerance to alcohol (n=11) or aggressive behavior (n=37) in patients taking Chantix and who also consumed alcohol. None of the cases of decreased alcohol tolerance reported that…

FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use

FDA reviewed five observational studies4-8 and two meta-analyses of placebo-controlled trials9,10 to examine the risk of cardiovascular events associated with testosterone replacement therapy (TRT). The five observational studies were retrospective cohort studies that reported conflicting results. Two of these studies found statistically significant cardiovascular harm with TRT (Vigen and Finkle), 4-5 two studies found a…

FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients

In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. Food and Drug Administration (FDA) is requiring additional label warnings prohibiting sharing of these injectable medicines. Insulin pens and pens for other injectable diabetes medicines should never be shared…

Safe Use Initiative

Acetaminophen Atypical antipsychotic medication use in pediatric populations Compounded oral liquid medications Epidural steroid injections Medication adherence Nonsteroidal anti-inflammatory drugs for the treatment of pain in geriatric patients Opioid misuse and abuse Opioid patient-prescriber agreement Opioid safe prescribing Preventing surgical fires Safe injection practices Unintentional medication overdoses in children Acetaminophen Improving prescription container labels for…