HHS/FDA Acts to Avoid Shortage of Sucraid and Strengthen the Drug's Safety

October 25, 2008 - The Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.  The approval will prevent a product shortage by allowing the sole manufacturer of the drug, QOL Medical, based in Kirkland, Washington, to obtain Sucraid’s active ingredient from a different manufacturer.

HHS/FDA also has taken new steps to protect the patients who use this treatment.  In addition, the agency is requesting the company to take measures designed to evaluate the risks of adverse events associated with the new version of Sucraid.

Sucraid, originally approved by HHS/FDA as an orphan drug on April 9, 1998, treats an enzymatic deficiency known as Congenital Sucrase-Isomaltase Deficiency (CSID).  CSID is an inherited disorder that affects about 400 patients worldwide, most of whom are Alaska Natives or belong to Nordic populations.  Some patients are as young as five months old.  Patients with CSID are deficient in an enzyme needed to break down the sucrose found in sugar and milk, and maltose found in carbohydrates such as bread and other staples of most diets.  A lack of this enzyme causes diarrhea, abdominal pain and severe cramping when eating these products.

HHS/FDA is concerned the newly manufactured Sucraid could contain increased levels of papain, an enzyme known to cause allergic reactions in some people.

For more information:

• U.S. Food and Drug Administration:

  http://www.fda.gov/

• Center for Drug Evaluation and Research: Questions and Answers about FDA's Enforcement Action Regarding Unapproved Topical Drug Products Containing Papain:

  http://www.fda.gov/CDER/news/papain/qa.htm

   (U.S. Food and Drug Administration)

Last revised: February 17, 2010