• By Keng Jin Lee
    American Society of Cataract and Refractive Surgery
    Cataract/Anterior Segment, Comprehensive Ophthalmology

    A recent alteration in the formulation of preservative-free epinephrine could lead to a shortage of mydriatic agents for ophthalmologists, according to an alert issued by the American Society of Cataract and Refractive Surgery (ASCRS). 

    The new formulation from PAR Pharmaceutical—a major manufacturer of generic drug products—contains 0.457 mg of sodium metabisulfite and 2.25 mg/ml of tartaric acid, and is thus not safe for use in the eye. 

    PAR has sent out updated prescribing information to providers on several occasions, and their 30 ml bottles of epinephrine 1 mg/ml (1:1000) specifically state on the label “Not for Ophthalmic Use”. The smaller, 1-ml single-use vials, however, do not display this warning. This could potentially result in inadvertent use of the new product in hospitals or ambulatory surgery centers. 

    Currently, there is no published data or experience with intracameral administration of solutions containing tartaric acid. The alert also noted that the ASCRS has become aware of several reports of toxic anterior segment syndrome (TASS) that appear to have resulted from the inadvertent use of this product. 

    Alternatives for inducing mydriasis recommended by the ASCRS include a preservative-free/bisulfite-free formulation by Belcher Pharmaceuticals, or a non-preserved, methylparaben-free epinephrine by Imprimis Pharmaceuticals. Surgeons could also consider using Omidria (Omeros Corporation), a phenylephrine 1%/ketorolac 0.3% combination drug that can be used in the irrigating solution during surgery.