FDA safety

FDA Safety Communication for Ocaliva
FDA Safety Communication for OcalivaFDA issues new communication about risk of liver injury with Ocaliva (obeticholic acid).
FDA to drug maker: Pull opioid pain drugPotential public health consquences prompts FDA to request removal of opioid pain medication.
FDA warns of serious risks associated with SGLT2 inhibitorsFDA recently issued a drug safety communication that the labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors include the risks of ketoacidosis and serious urinary tract infections, which can lead to hospitalization.
FDA warns of risk associated with off-label use of tramadol in kidsThe off-label use of tramadol in children following surgery may be problematic and healthcare professionals should consider other FDA-approved drugs for pain relief, according to a FDA safety communication.
FDA accelerated drug reviews need fixingThe FDA’s accelerated drug reviews skip some important research methods – they typically do not use trials with active comparators or clinical outcome measures, according to two new studies.
DPP-4 inhibitors may cause severe joint painFDA issued a warning this week that dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes may cause severe and disabling joint pain.
Study: FDA should warn consumers about chemical in weight loss supplements
Study: FDA should warn consumers about chemical in weight loss supplementsSeveral weight loss and fitness supplements contain the chemical BMPEA, a stimulant similar to amphetamine, according to a new study.
FDA should pull diabetes drug ads, group saysConsumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
FDA updates Chantix label to include possible alcohol interactionFDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.
FDA issues new labeling indications for testosterone replacement therapyFDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.