CUBICIN (DAPTOMYCIN) The Patient Counseling Information of the Package Insert (PI) was updated to add serious skin, kidney, lung, or other organ reactions. Additional details were included to highlight muscle pain or weakness (Myopathy and Rhabdomyolysis, Peripheral Neuropathy) and C. difficile-Associated Diarrhea (CDAD).
FLAGYL (METRONIDAZOLE) The Warnings and Precautions section of the PI was updated to include details for use in nursing mothers. There are no data on the effects of metronidazole on milk production. Animal studies have shown the potential for tumorigenicity. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FLAGYL and any potential adverse effects on the breastfed infant from FLAGYL or from the underlying maternal condition. Alternatively, a nursing mother may choose to pump and discard human milk for the duration of FLAGYL therapy, and for 48 hours after the last dose and feed her infant stored human milk or formula.
NEOPROFEN (IBUPROFEN LYSINE) The Warnings and Precautions section of the PI was updated to detail Serious Skin Reactions such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be fatal. Ibuprofen should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
IDACIO (ADALIMUMAB-AACF) The Warnings and Precautions section of the PI was updated to include malignancies in adults, liver enzyme elevations and uveitis in clinical studies.
OPDIVO (NIVOLUMAB) The Clinical Trials Experience section of the PI was updated to detail data from the study CHECKMATE-76K. The medication guide was also updated to state “OPDIVO may be used alone to help prevent Stage IIB, Stage IIC, Stage III or Stage IV melanoma from coming back after it has been completely removed by surgery”
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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