Why the study?
Does a generic formulation of doxorubicin increase the frequency of acute drug reactions in dogs with tumors compared to a proprietary brand?
Does a generic formulation of doxorubicin increase the frequency of acute drug reactions in dogs with tumors compared to a proprietary brand?
A generic formulation of doxorubicin was associated with an unusually high frequency of acute drug reactions in dogs compared to the proprietary brand.
Answers are grounded in this paper and cite their sources.
May prompt caution with generic doxorubicin in dogs; case report leaves open formulation effects pending controlled studies.
During a 4-month period, 34 dogs with tumors received a total of 60 doses of a single generic formulation of doxorubicin; 13 acute drug reactions were observed in these 34 dogs, and no acute reactions were observed after replacing the product with the proprietary brand. These reactions were characterized by one or more of the following signs: pruritus; head-shaking; urticaria; erythema of the pinnal, axillary, or inguinal regions; vocalization; vomiting; hyperemic or pale mucous membranes; high heart rate; and high respiratory rate. We propose that a component unique to generic doxorubicin was responsible for the unusually high number of acute drug reactions observed.
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Phillips et al. (1998) studied this question.
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