The US Food and Drug Administration and Health Canada have issued a warning to change the dose and dosing intervals of famotidine in patients with moderate or severe renal failure.

The drug

Famotidine, a histamine H₂ receptor antagonist used mainly to treat peptic ulcer disease, is excreted almost exclusively by the kidney. On March 23, 2001, the FDA issued a warning to physicians treating patients with renal failure, even moderate renal failure (creatinine clearance < 50 mL/minute), to use the drug with care.

Health Canada issued a similar warning on July 10, 2001.

Adverse effects to the central nervous system include psychiatric disturbances, insomnia, somnolence, anxiety and depression, among others. For other adverse effects, consult the product monograph.

Famotidine is marketed in Canada under the following brand names: Alti-famotidine, Apo-famotidine, Gen-famotidine, Riva-famotidine, Pepcid, Novo-famotidine, Nu-famotidine, Penta-famotidine, Famotidine and Rhoxal-famotidine.

What to do

The dose should be reduced by half or the dosing interval extended to 36 or 48 hours in patients with moderate or severe renal insufficiency. Previous recommendations were to reduce the dose only for severe renal insufficiency (creatinine clearance < 10 mL/minute). Renal function should be monitored in elderly patients who are using this drug.