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A New Warning for Patients Taking Bisphosphates for Osteoporosis
by admin on: June 29th, 2011

Bisphosphonates are drugs that are prescribed to patients that are diagnosed with a bone-thinning disorder called osteoporosis. In October 2010, the U.S. Food and Drug Administration (FDA) published a news release on their website indicating that there will be a change in the information contained on the labels of these drugs, as well as the medication guides that are provided as supplementary information.

The reason for this change stems from an announcement in March of 2010; the FDA was conducting an ongoing safety review of bisphosphonates drugs and their correlation with atypical femur fractures. After reviewing the data ??? including data that came from the American Society for Bone Mineral Research Task Force report ??? it became apparent that some patients may be at risk for atypical femur (thigh) fractures because of bisphosphonate use.

Oddly, this class of drugs has been shown to reduce or inhibit the loss of bone mass in patients that have been diagnosed with osteoporosis. One theory for this is that there is no known optimal range whereby patients receive benefit from taking these drugs. Simply put, the patients that are experiencing these fractures have been using bisphosphonates for periods that extend beyond five years.

Of course, the FDA is not recommending that patients stop taking prescribed medication, but rather to be advised of this risk and, if concerned, speak with their respective physician.

The specific oral drugs that will be affected by this labeling change are:

  • Actonel
  • Actonel with Calcium
  • Atelvia
  • Boniva
  • Fosamax
  • Fosamax Plus D
  • the generic pharmaceutical products for these drugs

In addition to the aforementioned oral drugs listed above, there are two injectable bisphosphonate drugs that will also be affected by this labeling change; these drugs are Boniva and Reclast.

Of note, there are bisphosphonate drugs that are used for Paget???s disease or for cancer/hypercalcemia (Didronel, Skelid, Zometa, and the respective generic products), but the new warning does not apply to these drugs.

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