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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
Transient difficulty with recall; Serotonin syndrome; Parkinsonism; Restless leg syndrome; Restlessness; Eye pain; Altered sense of smell; Photophobia; Pressure on eyes; Inner ear abnormality; Tunnel vision; Galactorrhoea; Irritable bowel syndrome; Burning of the tongue; Arthralgias; Amenorrhoea (cessation of menstrual cycles) Enuresis ...
Plazomicin is approved by the U.S. Food and Drug Administration (FDA) for adults with complicated urinary tract infections, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Enterobacter cloacae, in patients who have limited or no alternative treatment options. Zemdri is an intravenous infusion ...
The pharmaceutical company said the immediate recall came after it was discovered that 16 lots of the anxiety drug were mislabeled with the incorrect strength and National Drug Code (NDC) on them.
The US Food and Drug Administration has warned that antidepressants may be linked with suicidal thoughts and behaviors among youth since 2003, leading to a black box warning for minors in 2005 and ...
Buspirone, sold under the brand name Buspar, among others, is an anxiolytic, a medication primarily used to treat anxiety disorders, particularly generalized anxiety disorder (GAD). [ 10 ] [ 11 ] It is a serotonin 5-HT 1A receptor partial agonist , increasing action at serotonin receptors in the brain. [ 3 ]
Last November, the U.S Food and Drug Administration said it had received reports of patients developing a type of T-cell blood cancer after being treated with CAR-T therapies.Truist Securities ...
Aliskiren (brand names Tekturna and Rasilez) is the first in a class of drugs called direct renin inhibitors.It is used for essential (primary) hypertension. [2] While used for high blood pressure, other better studied medications are typically recommended due to concerns of higher side effects and less evidence of benefit.