Prevention of Preterm Labor with 17α-Hydroxyprogesterone (17OHP) Caproate: A Comparison of Adverse Drug Reaction Rates between Compounded and Commercial Formulations.

Abstract

Objective A commercial formulation of injectable 17α-hydroxyprogesterone (17OHP) for prevention of preterm birth was introduced in 2011; however, use of compounded formulations remains widespread. This study compared the frequency of adverse drug reactions (ADRs) associated with compounded versus commercial 17OHP formulations, aiding in provider assessment of 17OHP tolerability. Study Design A retrospective cohort evaluation of data obtained from the electronic medical record (EMR) of patients prescribed weekly 17OHP injections at an obstetric clinic between 2009 and 2015 was performed. A descriptive analysis characterized the frequency and proportion of ADRs associated with 17OHP administration. Patient differences between 17OHP formulations were identified with t-test, chi-square, or Fischer's exact tests. Results Of 175 patients included, 56% received commercial formulation and 44% received compounded formulation. ADRs occurred in 16 patients, all of whom received the compounded formulation (p < 0.001). The most common ADRs were injection site reaction (n = 7) and acute coughing following 17OHP administration (n = 6). Of patients with an ADR, 63% discontinued all medication therapy for prevention of preterm birth or changed to an alternative therapy. Conclusion Comparison of ADR rates between compounded and commercial formulation differed significantly. In addition to food and drug administration (FDA) compliance, providers may consider preferential use of the commercial formulation, since 21% of women receiving compounded product experienced an ADR.