The FDA is alerting animal health pros about the potential for dosing errors when using human-labeled products such as epinephrine. To avoid dosing errors, veterinarians should carefully review the label on an epinephrine product to determine if the strength is expressed as mg/mL or as a ratio. The FDA ordered the removal of ratios expressing the drug’s strength (such as 1:1,000 and 1:10,000) and mandated that strength be given only as the amount per unit of volume (mg/mL).
Source: AVMA@Work, August 1, 2017.
The warning to veterinarians follows an announcement made last month by the FDA that it was requiring labeling changes to three critical care medications approved for use in people, which also can be used extra-label by veterinarians in some situations. The changes affected the requirements for labeling the strength of these medications: epinephrine injection, isoproterenol hydrochloride injection, and neostigmine methylsulfate injection.
INSIGHTS: Sales reps and practice managers need to ensure practices’ emergency protocols and charts are updated with the new label information for the affected pharmaceuticals.