To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
EPINEPHRINE (EPINEPHRINE) The Adverse Reactions section of the Approved Drug Label (ADL) was updated regarding Cardiovascular disorders including stress cardiomyopathy.
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE) The Adverse Reactions, Postmarketing Experience section of the Approved Drug Label (ADL) was updated regarding Immune System Disorders stating that Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.
MERREM IV (MEROPENEM) The Adverse Reactions, Postmarketing Experience section of the Approved Drug Label (ADL) was updated regarding Hepatic Disorders including drug-induced liver injury.
CUBICIN (DAPTOMYCIN) The Adverse Reactions, Postmarketing Experience section of the Approved Drug Label (ADL) was updated regarding Metabolic and Nutritional Disorders including hyperkalemia.
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER The Warnings and Precautions section of the ADL was updated to include a new subsection regarding Rhabdomyolysis. Rhabdomyolysis has been reported with the use of linezolid, including Linezolid injection. If signs or symptoms of rhabdomyolysis such as muscle pain, tenderness or weakness, dark urine or elevated creatine phosphokinase are observed, discontinue Linezolid injection and initiate appropriate therapy. These details were also included within the Adverse Reactions and Patient Counseling Information. Additional Adverse Reactions listed throughout the ADL include: Myelosuppression, Peripheral and Optic Neuropathy, Serotonin Syndrome, Clostridioides difficile-Associated Diarrhea, Lactic Acidosis, Convulsions, Hypoglycemia, and Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with Coram.