The Saudi FDA has communicated a warning circular about the risk of developing kidney failure due to using Aclasta®) product. The warning included the possibility of increase of this risk when using this product by patients who have deficiency of kidney functions or other risk factors such as aging, or using other drugs that may affect the kidneys e.g. urine stimulating drugs, or lack of body fluids after using this product. SFDA advised health care professionals not to use Aclasta®) product for patients whose Creatinine Clearance level is lower than 35% or patients who have acute kidney failure. SFDA has also announced that the manufacturer will communicate a message to all health care professionals advising them of the risk of developing kidney failure when using Aclasta®) product and will update the product bulletin to include this warning.
SFDA recommends that the following instructions shall be observed by Health Care Professional:
• Stop using Aclasta®) for patients whose Creatinine Clearance level is lower than 35ml/min. or patients with acute kidney failure
• Be cautious when prescribing Aclasta®) for patients who use other products affecting kidney functions
• Measure Creatinine Clearance level every time before giving Aclasta®) to the patient and measure Creatinine Clearance level periodically for patients using this product. A temporary increase of Creatinine level occurs in patients who suffer deficiency of kidney functions
• Emphasize the importance of giving adequate hydration to patients before and after using Aclasta®), particularly for patients of old age or patients using urine stimulating drugs