In recently released FDA Drug Safety Newsletter the agency published very disturbing news for people taking Reclast, the FDA-approved annual IV osteoporosis treatment. From 2007 through 2009 Reclast was FDA approved for once yearly IV treatment of osteoporosis in postmenopausal women, Paget’s disease of bone, for glucocorticoid induced osteoporosis and for osteoporosis in men. From April 2007 through February 2009 the agency received 24 reports of renal impairment and acute renal failure associated with the use of Reclast-and seven people died. The question is what’s FDA doing about this drug? Nothing. No, pardon me. They encourage physicians to avoid using it in patients with preexisting renal impairment, to be surethat the patients are adequately hydrated before the infusion, to infuse over period of at least 15 minutes (poor nurses are always busy) and report new cases! What about the manufacturer? The information on the current Warning and Precautions, renal impairment label reports an increase in creatine levels, and the manufacturer recently updated Warning and Precautions, Post marketing Experience, and drug interactions section of the Reclast label to include data on acute renal failure.
My advice? Don’t even consider this treatment! Why risk adverse events like osteonecrosis of the jaw (dead jaw), atrialfibrillation (serious abnormal heart rhythm), dialysis or death, when you can find other safe treatments?It is time to start taking care of ourselves, because …well, nobody else will.