2016 Volume 4 Issue 2 Pages 97-101
Aim: To compare the safety and efficacy of Utemerin, an original ritodrine hydrochloride drug formulation, with those of generic Ritodrine.
Methods: We examined patients who developed side effects, targeting 400 cases in which either Ritodrine or Utemerin was administered intravenously between 2006 and 2011.
Results: The number of cases with side effects was significantly greater in the Ritodrine group than in the Utemerin group (96 cases [48%] vs. 55 cases [27.5%], respectively; P<0.001). The most common side effect with both drugs was rash, which was significantly more frequent in the Ritodrine group than in the Utemerin group (40 cases [20%] vs. 25 cases [12.5%], respectively; P=0.04). The number of cases with mid-treatment changes owing to side effects did not significantly differ between groups (Ritodrine: 32 cases [16%] vs. Utemerine: 24 cases [12%]; P=0.31).
Conclusions: Side effects were more frequent with Ritodrine than with Utemerin. It has not been long since the introduction of generic drugs in Japan, and post-use studies conducted shortly after their introduction are insufficient. However, the use of generic drugs that are detrimental to patients are contraindicated, and thus post-use studies are needed to confirm generic drug safety and efficacy.
