March 11, 2011
If you or someone you care about is using the osteoporosis drug Reclast, please read the alert below. This medication has been linked to serious kidney damage.
On October 12, 2010, presumably at the behest of the Canadian govenment, Novartis, the maker of the osteoporosis-infusion drug zoledronic acid (known as Reclast in the U.S. and Aclasta in Canada) sent Canadian health professionals and patients letters warning them of the possibility of kidney toxicity with use of the drug.
Since Novartis did not send similar letters to U.S. health professionals and patients, we are providing our readers with the information sent to Canadian doctors and consumers. We also urged the FDA to require Novartis to issue these warnings to U.S. doctors and patients.
As of April 2010, Novartis had received 265 reports of kidney damage after consumers used Reclast. The true number of patients whose kidneys have been harmed is likely far greater, as only a small percentage of adverse events are ever reported.
Renal failure requiring dialysis or with a fatal outcome has occured. The elderly, those taking drugs that had the potential to damage kidneys, and those on diuretics or who experienced dehydration after Reclast administration were found to be most at risk.
What You Should Do
Novartis provided the following guidance for consumers:
- “Before you take [Reclast], talk to your doctor or pharmacist if you have, or used to have, a kidney problem.”
- “Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any you have bought without a prescription. It is especially important for your doctor to know if you are taking any medicines known to be potentially harmful to the kidneys (such as nonsteroidal anti-inflammatory drugs (NSAIDs)).”
- “Make sure that you drink a sufficient amount of water (at least two glasses or 500 mL) before and after your treatment with [Reclast].”
- “[Reclast's] infusion should take a minimum of 15 minutes.”
If you are currently being treated with Reclast, you should consider discussing alternative treatments with your physician. Possible alternatives include lifestyle changes and the medications alendronate (FOSAMAX) and risedronate (ACTONEL).
Do not discontinue use of any medication without consulting your physician first.