Kidney stones, or nephrolithiasis, are a
potential side effect of certain antiretroviral
drugs, notably indinavir (Crixivan).
Stones can occur when a drug precipitates and forms crystals in the kidneys. Symptoms
include severe flank pain and blood in the urine.
In the May 31, 2007 issue
of AIDS, scientists from the Food and Drug Administration's Center for
Drug Evaluation and Research Division of Antiviral Products summarized reported
cases of nephrolithiasis in people taking atazanavir
(Reyataz).
The
authors searched the agency's Adverse Event Reporting System -- which collects
voluntary reports from clinicians and patients -- for reports of kidney stones
in HIV-infected individuals using atazanavir-based regimens. A total of 30 cases
were identified over a 4-year period (December 2002 through January 2007).
Of
the 30 cases, 21 were in men, 5 were in women, and 4 were not specified; 5 patients
had a known prior history of kidney stones. Interestingly, of the 20 cases that
included complete information about the patient's HIV treatment, 13 were also
taking tenofovir (Viread, also a component of the fixed-dose pills Truvada
and Atripla), which has been associated
in some studies with impaired kidney function.
Several of the patients
required hospitalization for management, including lithotripsy (use of shock waves
to break up kidney stones), ureteral stent insertion, or endoscopic stone removal.
Some cases of nephrolithiasis resulted in atazanavir discontinuation.
While
this adverse event appears to be uncommon overall, the authors wrote that, "Healthcare
professionals and patients should be informed that nephrolithiasis is a possible
adverse event with atazanavir."
Manufacturer
Bristol-Myers Squibb has revised the drug's package insert to include the potential
for this side effect.
06/22/07
Reference KM
Chan-Tack, MM Truffa, KA Struble, and others. Atazanavir-associated nephrolithiasis:
cases from the US Food and Drug Administration's Adverse Event Reporting System.
AIDS 21(9): 1215-1218. May 31, 2007.
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