Spironolactone is an aldosterone antagonist used as a potassium-sparing diuretic for patients who suffer from: chronic heart failure, edema caused by heart or liver failure, and/or hypertension. The agency has recently released stricter guidance regarding crushing/compounding, recommending against using crushed/compounded products considered “essentially copies of a commercially available drug product” without permission, especially if an FDA-approved alternative exists. Increasing Scrutiny From the FDAĬrushed/compounded formulations have come under increasing scrutiny from the FDA due to fatalities related to contamination. The Centers for Disease Control and Prevention investigators found in 2007 that compounded drugs have a higher risk of contamination than commercially manufactured drugs, and compounding pharmacies have “generally lower quality-control standards than pharmaceutical manufacturers”. In a 2006 survey, the FDA found that 12 of the 36 compounded products surveyed failed quality testing, with potency ranging from 68% up to 268% of the labeled dosage.
Crushed/compounded formulations are not tested for safety or efficacy. These dosing inconsistencies of compounded suspensions have long been a persistent challenge for pharmacists and patients. However, crushed/compounded formulations can exhibit a wide variation in potency due to non-uniformity of compounded materials.
Patients who have difficulty swallowing are often given crushed/compounded versions formulations of the prescriptions.
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