FDA MedWatch Alert
Dear Guideline Developer,
As you may know, on January 5, 2006, GlaxoSmithKline and the U.S. Food and Drug Administration (FDA) notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone. In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.
You may access this alert, including links to the GSK Dear Healthcare Professional letter, at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Avandia
When an alert such as this is issued, we search the National Guideline Clearinghouse (NGC) database for all guideline summaries (already published and/or in our work queue) that mention the drug(s) in question. During this search, a guideline from your organization was identified. In keeping with our policy, we will insert a notice into the NGC summary to alert readers to the FDA Alert. NGC has recently added a new field to our summary called “FDA Warning/Regulatory Alert” where we intend to place this notice. This field is positioned near the beginning of the summary so that it is clearly visible to our users. This new field is intended to identify warnings and/or revised regulatory information released by the U.S. Food and Drug Administration (FDA) or other official regulatory bodies for a drug and/or device for which recommendations are provided in the original guideline document(s).
Be assured that no action is required on your part. Modification of the summary will begin immediately and you should not see any interruption in the posting of your organization's summary on the NGC web site. This e-mail is our way of notifying you of NGC's planned response to the FDA alert. Please also note that NGC will periodically monitor the relevance of this notice within the NGC summary and may remove it at some point in time in the future.
Please feel free to contact me at 610.825.6000 ext. 5216 or by e-mail (lhaskell@ecri.org) if you would like to discuss this further.
Sincerely,
Lisa T. Haskell, MS, OTR/L
Manager, Clinical Content Development
National Guideline Clearinghouse
ECRI
5200 Butler Pike
Plymouth Meeting, PA 19462-1298
610/825-6000 ext. 5216
lhaskell@ecri.org
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