comscoreFDA Warning: Reclast May Cause Severe Kidney Problems

FDA Warning: Reclast May Cause Severe Kidney Problems

On Sept. 1, 2011 the U.S. Food and Drug Administration warned doctors and patients that Reclast may cause severe kidney problems.
Sep 1, 2011.This article is archived
We archive older articles so you can still read about past studies that led to today's standard of care.
Reclast (chemical name: zoledronic acid) is given intravenously once a year to prevent or treat osteoporosis in postmenopausal women. On Sept. 1, 2011 the U.S. Food and Drug Administration (FDA) warned doctors and patients that Reclast may cause severe kidney problems. These kidney problems can lead to kidney failure, the need for kidney dialysis, and could be life threatening.
Kidney problems after receiving Reclast are more likely in women who:
  • already have kidney problems
  • take a diuretic (medicine that removes water from the body)
  • are dehydrated when they get a Reclast injection or become dehydrated afterward
  • take other medicines that can cause kidney problems
As a woman gets older, serious kidney problems from Reclast become more common.
The announcement came after a number of cases of serious kidney problems following treatment with Reclast came to the agency's attention. The manufacturer of Reclast must include new warnings about kidney risks and advice on monitoring kidney function before and after treatment with Reclast in information given to doctors and patients. The new prescribing information includes the recommendation that women scheduled to get Reclast drink at least two glasses of water or other liquid within a few hours of treatment to reduce the risk of kidney problems.
Zometa (chemical name: zoledronic acid), which contains the same active ingredient as Reclast, is used to protect bones and reduce bone fracture risk in people diagnosed with cancer (including breast cancer) that has spread to bone. Information about kidney damage risks and related precautions for people being treated with Zometa are already included in that medicine's prescribing information.
Reclast is a bisphosphonate, a type of medicine used to prevent or treat osteoporosis. Other bisphosphonates are:
  • Actonel (chemical name: risedronate)
  • Boniva (chemical name: ibandronate)
  • Fosamax (chemical name: alendronate)
These bisphosphonates are pills taken by mouth.
The special FDA warning only applies to Reclast, not the other bisphosphonates that are taken as pills. Still, any bisphosphonate should be used with caution in women who have kidney problems or are at risk for them.
In addition to bisphosphonates, postmenopausal women have two other options to treat osteoporosis:
  • Evista (chemical name: raloxifene), a selective estrogen receptor modulator (SERM), is a pill taken once a day. Evista also is used to reduce the risk of breast cancer in women diagnosed with osteoporosis.
  • Prolia (chemical name: denosumab), a targeted therapy, is given as an injection once every 6 months.
If your doctor has recommended Reclast for you to prevent or treat osteoporosis, ask your doctor about the risk of kidney problems before your first or next dose of Reclast and whether Reclast is still a good choice for you. If you are to get Reclast, be sure to ask your doctor what you should do before and after treatment to minimize the risk of kidney problems. It's also a good idea to ask about any kidney function monitoring your doctor recommends before and after treatment.
The Bone Health section has detailed information on bone health, how bone health is measured, and how both menopause and breast cancer treatments can affect bone health. You will also find tips to keep your bones as strong as they can be and an overview of osteoporosis treatment and prevention options you and your doctor may consider.

— Last updated on February 22, 2022, 9:53 PM

Share your feedback
Help us learn how we can improve our research news coverage.