The labels on the product and the package insert currently being distributed by Hospira do not reflect the most up-to-date information and warnings. The missing information and warnings may increase the risk to patients and may result in significant patient harm requiring medical intervention. Specifically, these warnings are detailed below: Vincristine sulfate should only be administered by the intravenous (IV) route. Administration of Vincristine sulfate by any other route can be fatal. Syringes containing this product should be labelled "WARNING- FOR IV USE ONLY". Extemporaneously prepared syringes containing this product must be packaged in an overwrap which is labelled "DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FOR INTRAVENOUS USE ONLY-FATAL IF GIVEN BY OTHER ROUTES." Contraindication of Vincristine in patients with demyelinating Charcot-Marie-Tooth Syndrome. Potential risk of acute shortness of breath when Vincristine is coadministered with Mitomycin-C and gastrointestinal toxicities including necrosis with administration of Vincristine.
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