FDA MedWatch - Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer

FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Thu, 21 Jul 2011 12:17:09 -0500

Title: 
    FDA MedWatch -  Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal  Cancer

Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal   Cancer

Includes: Fosamax (alendronate), Actonel (risedronate), Boniva  (ibandronate), Atelvia (risedronate delayed release), Didronel  (etidronate), and Skelid (tiludronate)

AUDIENCE: Geriatrics, Family Practice, Internal Medicine
ISSUE:  FDA notified healthcare professionals and patients about its ongoing  review of data from published studies to evaluate whether use of oral  bisphosphonate drugs is associated with an increased risk of cancer of  the esophagus. FDA has not concluded that taking an oral bisphosphonate  drug increases the risk of esophageal cancer. There are insufficient  data to recommend endoscopic screening of  asymptomatic patients. FDA  will continue to evaluate all available data supporting the safety and  effectiveness of bisphosphonate drugs and will update the public when  more information becomes available.
BACKGROUND:  Oral bisphosphonates are commonly used for the prevention and treatment  of osteoporosis as well as to treat other bone diseases such as Paget's  disease. There have been conflicting findings from studies evaluating  the risk of esophageal cancer. Esophagitis and other esophageal events  have been reported, particularly in patients who do not follow the  specific directions for use of oral bisphosphonates. See the Data  Summary in the Drug Safety Communication for additional details.
RECOMMENDATION:  Patients should talk with their healthcare professional about the  benefits and risks of taking oral bisphosphonates and how long they  should expect to take them. Patients should talk with their healthcare  professional if they develop swallowing difficulties, chest pain, new or  worsening heartburn, or have trouble or pain when swallowing. Patients  should be instructed to carefully follow the directions for use of the  oral bisphosphonate drug they are prescribed.

Healthcare  professionals and patients are encouraged to report adverse events or  side effects related to the use of these products to the FDA's MedWatch  Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and  return to the address on the pre-addressed form, or submit by fax to  1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264087.htm

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