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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
The National Osteoporosis Foundation has named Barbara Hannah Grufferman as its first Bone Health Ambassador. In this newly-established role, Grufferman, a well-known advocate for healthy and positive living, will dedicate her time, talent and energy to raise awareness for osteoporosis and the importance of building strong bones for life.
Thanks to a generous gift from The Samuel J. & Ethel LeFrak Charitable Trust, the National Osteoporosis Foundation met its Generations of Strength fundraising goal one year early. NOF launched the Generations of Strength initiative in September 2011 with the goal of raising $2 million in two years to improve patient care for the most vulnerable – those who have broken bones due to osteoporosis – and to protect future generations from the disease.
The National Osteoporosis Foundation (NOF), the nation’s leading health organization dedicated to preventing osteoporosis and broken bones, has named Claire Gill as its Senior Director of Marketing, Consumer and Corporate Outreach. Gill brings extensive experience in public relations and marketing communications to this newly-established role.
