USP Quality Review

No. 70, Issued November 1999

Drug Product Problem Reporting Program Gentamicin Report Abstracts

The problem was observed in June 1999. Almost immediately following the first dose of gentamicin 560-mg (7mg/kg dosing weight) every 24 hours, the patient experienced an anaphylactic-like reaction with severe shaking, choking, and dyspnea, requiring administration of diphenhydramine and methylprednisolone. The possibility exists that the reaction could be a result of the endotoxin content of the product, because of the large dose. The patient received the facility's standard once-daily gentamicin dose.

The problem was observed in June 1999. Three patients suffered classic "endotoxin" reactions (fever, malaise, aches, and rash) following loading doses of gentamicin. No subsequent morbidity was reported.

The problem was observed in July 1999. A 56-year-old female was admitted for a surgical procedure. Gentamicin 80 mg IV every eight hours was ordered and three doses were given without incident. Unasyn® 1.5 g IV, every six hours was ordered for the patient for pyelonephritis. Due to gastrointestinal complaints from the Unasyn, the patient was switched to gentamicin 300 mg IV daily. Within one hour of the gentamicin dose, the patient complained of "a sense of impending doom," and developed severe rigors, elevated blood pressure, tachycardia, and shortness of breath. The patient required a code call. The patient improved dramatically after being treated with methylprednisolone, meperidine, and acetaminophen. Gentamicin was discontinued and all symptoms have resolved. Within an hour of hanging the product, the reporter learned that both lots given to the patient had been recalled.