Reclast Kidney Damage Warning Issued in Canada, But Not in U.S.

A consumer watchdog is urging federal regulators to force Novartis to issue warnings in the United States about potential side effects of Reclast, an osteoporosis drug that has been linked to a risk of kidney problems. 

Novartis sent a “Dear Health Care Professional Letter” to providers in Canada on October 12, 2010, alerting them about a potential link between Reclast and renal problems. However, no such warning has been provided to doctors in the United States.

In a letter sent to the FDA on March 10, Public Citizen urged the federal regulators to require the drug maker to warn health care providers in the U.S. about the potential risk of kidney damage from Reclast.

Public Citizen accuses Novartis of failing to warn physicians and patients in the United States about the potential Reclast side effects, despite growing evidence linking the osteoporosis drug to serious and potentially life-threatening problems. The group also suggests that the FDA has dropped the ball by failing to action to require such a warning in the five months since health care providers in Canada were alerted about the risk.

In the letter sent to Canadian doctors, Novartis indicated that at least 265 reports of kidney damage from Reclast had been received as of April 20, 2010.

Sold as Aclasta in Canada, Reclast (zoledronic acid) has reportedly been linked to kidney problems in some users after a single dose. The drug maker also indicated that kidney failure requiring dialysis treatment and death from kidney problems have occurred in some cases, particularly when patients have a history of renal impairment.

The letter greatly strengthens previous warnings on Reclast labels regarding kidney risks, some of which were already known. Public Citizen is urging the FDA to force Novartis to send a similar letter to U.S. doctors with the same enhanced warnings.

Reclast, which is part of a class of medications known as bisphosphonates, was approved by the FDA in 2007 for treatment of postmenopausal osteoporosis and is also approved for the treatment of Paget’s disease. It is given in 5 mg annual injections. It is sold as Zometa with injections given every 3 to 4 weeks.

In October 2010, the FDA did issue a warning about a potential link between atypical femur fractures and side effects of Reclast and other bisphosphonates used for treatment of osteoporosis. Medications like Reclast, Actonel, Boniva, Atelvia and Fosamax have been linked to low-energy femur fractures, which typically occur from falls of standing height or less. Generally, these types of femur fractures are very uncommon and account for less than 1% of all hip and femur fractures. The FDA found that they occur predominantly in people taking bisphosphonates.