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FDA: New Label Warning for Reclast
The FDA has issued new warning label information for the osteoporosis drug zoledronic acid (Reclast) indicating that the drug should not be used in patients with significant renal impairment and stating that physicians should screen patients for kidney dysfunction before starting them on the drug. The FDA also identifies risk factors that physicians should take into consideration when prescribing Reclast including advanced age, concurrent treatment with other nephrotoxic drugs, and dehydration secondary to fever, sepsis, gastrointestinal losses or diuretic therapy. This is an amplification of the prior warning that all bisphosphonates not be used in people with creatinine clearance below 30-35 ml/min. Patients should eat and drink at least 1-2 full glasses of fluid on the day of the infusion. The infusion must be given over at least 15 minutes.
As the leading voice for osteoporosis patients, the National Osteoporosis Foundation wants all patients and physicians to be aware of the new warnings and take them into account when taking or prescribing Reclast. As with all medications, the risks and benefits of treatment must be carefully considered and health professionals are advised to screen their patients for renal impairment, advanced age or dehydration and ask their patients about any symptoms they may be experiencing before administering Reclast. As always, patients should consult with their health care providers to discuss their risk factors and determine the method of treatment that will be most effective for them.
Click here (link to:http://www.fda.gov/Drugs/DrugSafety/ucm270199.htm) for additional information.
The latest
Last week, a Food and Drug Administration (FDA) Panel voted that the risks of calcitonin salmon outweigh the benefits for the treatment of postmenopausal osteoporosis. The panel joined health authorities around the world in reviewing the drug’s safety after two recent studies showed slightly higher rates of cancer among patients taking calcitonin. The panel voted against continued use of the drug by a narrow majority, pointing out that it has not been found very effective in preventing bone fractures.
In today's Washington Post article "Calcium and Vitamin D findings show that caring for your bones can be compilicated," NOF's senior clinical director, Dr. Felicia Cosman helps clear up some of the confusion around the recent and conflicting research on calcium and vitamin D. She says: "It’s confusing, even for doctors. But there’s a common thread: None of the heart or kidney risks were associated with calcium from food."
CIRCA, the leading international buyer of fine jewelry, diamonds and watches, announced a new partnership with NOF at a Generations of Strength luncheon at the Friars Club in New York City on February 26. To kick-off the partnership, CIRCA’s Acting CEO Mary L. Forté presented NOF Executive Director and CEO Amy Porter with a check for $25,000, to support NOF’s mission.
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