The Emerging Infections Network (EIN) is a forum for infectious diseases consultants and public health officials to report information on clinical phenomena and epidemiological issues with public health significance. Any diagnostic or therapeutic recommendations and all opinions presented are those of the individual contributor. They do not necessarily represent the views of EIN, IDSA (EIN’s sponsor), or the Centers for Disease Control and Prevention (CDC), which funds EIN. The reader assumes all risks in using this information.
Last summer, several EIN members discussed vancomycin and acute renal toxicity, a topic raised again recently on the forum when the Food and Drug Administration (FDA) issued a statement, providing new information and study results for clinicians.
A member in Indiana started the initial discussion in August 2011. “We seem to be seeing patients with rapid onset of acute renal failure on IV vancomycin again (and also piperacillin-tazobactam),” the member wrote. “We had wondered about intermittent ‘bad lots’ of vancomycin but were unable to pin it down. Pharmacy monitoring has not changed. Anyone else noting the same?”
A respondent in New York also reported several similar cases. “My three patients required hemodialysis and prolonged hospitalization. All patients were young and on no other nephrotoxic medications,” the member wrote. “Is there any formulation of generic vancomycin or manufacturing process that has changed?”
The cases appeared to be unrelated to age, sex, weight, or underlying illness, noted a member in Florida. “My theory is that there is a certain genetic polymorphism that causes this renal insufficiency that is not seen with other combination antibiotics,” the member noted. “Maybe in the future we can predict who should not get this combination if there truly is a predisposition from a genetic basis as the field of pharmacogenetics is finding new genetic polymorphisms that lead to drug toxicity.”
A member in Iowa described two recent outpatient parenteral antimicrobial therapy patients who experienced a rapid change in renal function (creatinine > 4) “within a span of one weeks duration,” with no good explanation. From Michigan, another respondent wrote of a “34-year-old patient who developed increase in serum creatinine, which kept escalating along with nonoliguric renal failure within 48 hours of starting vancomycin. It was held, but the creatinine continued to increase up to10. There was one trough at 24.”
“Did you recently change your trough levels to coincide with the new recommendations of troughs 15-20 for most indications?” an EIN member in California asked. “If so, that’s the issue. We almost never saw toxicity with levels 5-10, or even 10-15. As soon as we instituted 15-20 for serious infections, we saw renal toxicity.”
“Part of the equation is the purity of generic vancomycin,” a member in Oregon wrote, noting that manuscripts on the subject recently had been submitted for publication. “Back in the 1980s, we had a reliable animal model of aminoglycoside nephrotoxicity,” the member continued. “In that model, the Eli Lilly drug, even in enormous dosage, did not cause any evidence of nephrotoxicity. Low dose vancomycin greatly amplified gentamicin nephrotoxicity, as was later validated clinically.”
In March 2012, one of the original respondents posted an update, referencing FDA’s recent statement, which cited two new FDA studies published online in February:
“Additional studies are underway to determine efficacy of generic vancomycin preparations in animals,” the member added. “I am unaware of any animal nephrotoxicity studies.”
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The Emerging Infections Network (EIN) is a provider-based sentinel network designed to help the public health community detect trends in emerging infectious diseases.
A joint project of IDSA and the Pediatric Infectious Diseases Society (PIDS) with funding from the Centers for Disease Control and Prevention (CDC), EIN tracks emerging infectious diseases and keeps the public health community up to date with new disease trends, difficult cases, and other issues affecting members’ clinical practices. The Network provides a great opportunity for members to share knowledge quickly across large geographical distances. Both IDSA and PIDS members are eligible to join. Click here for more information or to join EIN.
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