FDA Issues Warning On Osteoporosis Drug Reclast

Reclast is a Novartis drug (chemical name: zoledronic acid or zoledronate) that prevents the release of calcium from bones, thus reducing the rate of bone mass deterioration, especially in post-menopausal women. The chemical is also sold under the brand name Zometa. It is prescribed for men to help increase their bone mass and is especially recommended in persons who will be on any steroid combination for over a year as a part of their osteoporosis management program. ⁽¹⁾

Now there is sufficient evidence that Reclast raises the risk for kidney failure in osteoporosis patients especially if they already have kidney impairment or suffer from severe dehydration. The U.S Food and Drug Administration (FDA) has gone further to warn such patients as those on potentially kidney-damaging medications or diuretics while they are being given Reclast.

Though the drug which was approved in April 2007 had said that kidney failure was a rare scenario for persons, case counts only two years later, began to show as many as 24 kidney failure incidences after starting the drug, out of which 5 patients actually died. As a result, the FDA recommended that doctors who prescribe Reclast ought to monitor the patient’s serum creatinie regularly when on the drug to reflect on the patient’s kidney health. However, the next two years saw more than 11 Reclast related deaths brought on by kidney failure. ⁽²⁾ Besides this, 9 cases reported kidney damage calling for dialysis.

So what does the FDA now recommend for Reclast and it’s usage? ⁽³⁾

1. The agency has now notified healthcare professionals as well as patients of an update to the drug label for Reclast concerning the dangers of kidney failure.
2. FDA recommends the calculation of creatinine clearance before each dose of Reclast.
3. For those who are even mildly at risk should be monitored for kidney health between doses of Reclast.
4. Reclast is not to be prescribed for patients with creatinine clearance less than 35 mL/min, or in such persons whose diagnostic tests show positive results for kidney impairment.
5. The healthcare providers and patients are urged to report to the FDA’s MedWatch program should they observe/experience any adverse effect after Reclast dosage administration.
6. The agency advises patients that they should explore other options beyond Reclast with their doctor if they have kidney conditions.
7. FDA also recommends that osteoporosis patients inform their physicians of all the medications they are taking so that their doctor’s can take an informed decision for osteoporosis treatment and management.

*Source: U.S Department of Health and Human Services – FDA

Sources:

1. Reclast, Drugs.com, 2011. http://www.drugs.com/reclast.html
2. M. McMillen, L. J Martin MD, FDA: Osteoporosis Drug Reclast Raises Kidney Failure Risk, WebMD, September 2011. http://www.webmd.com/osteoporosis/news/20110901/fda-osteoporsis-drug_ups-kidney-failure-risk
3. Reclast (zoledronic acid): Drug Safety Communication – New Contraindication and Updated Warning on Kidney Impairment, U.S Department of Health and Human Services – FDA, September 2011. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270464.htm