The Food and Drug Administration (FDA) has posted a notice relating to the availability of Sucraid (sacrosidase oral solution; QOL Medical). The product is currently in shortage because the process that has been used to manufacture the product does not meet the FDA’s good manufacturing practices. While the company works to meet these pharmaceutical standards, a limited amount of unapproved product will be available to physicians and patients who consent to the use of this product.
Sucraid is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). CSID is a chronic, autosomal recessive, inherited phenotypically heterogeneous disease with very variable enzyme activity. In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Sucraid helps to improve the breakdown and absorption of sucrose from the intestine which can help relieve the gastrointestinal symptoms of CSID.
The unapproved lot of Sucraid contains 650 boxes (each box containing two bottles). The FDA is recommending that clinicians prioritize access to the drug for patients with severe CSID and for patients with evidence of malnutrition. As the product was manufactured at an unapproved facility, clinicians should be aware that the bottles from this lot may contain bacterial byproducts, which may be a safety concern, especially in patients with weakened immune systems. The risks of this product should be weighed against the benefits and discussed with patients.
The FDA is working closely with QOL Medical to alleviate the Sucraid shortage by providing assistance to the company to help resolve the manufacturing issues. In the meantime, the FDA has posted consent forms for both prescribers and patients to review and fill out. A separate Acknowledgement Form needs to be completed for each patient prescribed Sucraid. As of May 4, 2017, these forms must be filled out in order to receive a prescription for Sucraid. The completed forms should be faxed to SucraidASSIST at (800) 632-1944.
The consent forms can be found here.
For more information visit FDA.gov.