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News

Notification from FDA Regarding Sucraid

The CSID Society received notification from the Food and Drug Administration regarding the drug Sucraid. Please refer directly to the FDA website for accurate and current information regarding the Sucraid drug shortage. The following is the information provided by the FDA:

http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sacrosidase (Sucraid) Oral Solution&st=c&tab=tabs-1

In the posting there is a link to the Physician and Patient Informed Consent Forms, and QOL's Questionnaire, and a link to related information for the public to reserve supply for serious cases.  The forms state:

"As a temporary measure, since Sucraid is in shortage, the FDA has allowed the release of Sucraid lot number A1147. This lot of Sucraid was manufactured at an unapproved facility under conditions that did not meet FDA's standards for pharmaceuticals."

 The form requests physicians to:

". . . inform both the manufacturer of Sucraid, QOL Medical LLC (Phone: 1-866-469-3773 | Fax: 772-365-3375 | Email: info@qolmed.com), and the FDA at 1-888-INFO-FDA (463-6332) of adverse events that occur while the patient is taking Sucraid."