The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication today, notifying healthcare professionals and patients that the FDA is conducting “an ongoing review of data from published studies” to evaluate whether taking oral osteoporosis drugs (generically called, “bisphosphonates”) may lead to an increased risk of cancer of the esophagus.
The drugs named in the FDA’s Drug Safety Communication included: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate).
The Drug Safety Communication was published on the FDA’s Website, and a summary form of the notice was also e-mailed to healthcare professionals in the fields of Geriatrics, Family Practice, and Internal Medicine, and to patients and consumers who have subscribed to the FDA’s MedWatch communications.
In its Drug Safety Communication today, the FDA said that, “At this time, FDA believes that the benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks. FDA’s review is ongoing and the Agency has not concluded that patients taking oral bisphosphonate drugs have an increased risk of esophageal cancer.” The Agency further stated that, “There are insufficient data to recommend endoscopic screening of asymptomatic patients.”
However, the FDA announced that it “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 – Conflicting Findings:
In its Communication, the FDA provided the following background information:
The FDA made the following recommendations for patients:
In the full version of the Safety Communication posted on the FDA’s website, the Agency also provided Additional Information for Patients and Additional Information for Healthcare Professionals.
The FDA urged healthcare professionals and patients to report adverse events or side effects related to the use of osteoporosis drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, as follows:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm or
- Download a form or call 1-800-332-1088 to request a reporting form, and then complete and return to the form 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:
See also our previous reports on:
And see generally, HelpngYouCare™’s resource pages on:
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