Causes and consequences of hypokalemia in patients on tenofovir disoproxil fumarate.

To determine the spectrum of clinical manifestations of hypokalemia associated with tenofovir, we reviewed all reports of grades 3/4 hypokalemia received by Gilead Sciences Department of Safety and Public Health. Of 32 cases identified in 2001-2006, 23 were attributed to proximal renal tubular dysfunction, and medically significant conditions attributable to hypokalemia occurred in four, which all improved with medical management. In none of the six fatal cases did hypokalemia appear to contribute to death.

The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: the first 4 years.

Objective: To characterize the safety profile of tenofovir disoproxil fumarate (DF) for the treatment of HIV infection in adults over the first 4 years of use.

Methods: A tenofovir DF expanded access program (EAP) was initiated in 2001; safety data were examined from this program and from the manufacturer's database, which contained reports of all postmarketing adverse drug reactions received up to 30 April 2005. Specific analyses were performed to characterize the renal safety of tenofovir DF.