Related Information for Sacrosidase Oral Solution
Re-verified May 2, 2018
FDA coordinated with QOL Medical, LLC (QOL), the company that manufactures Sucraid (sucrosidase) oral solution, to release an individual unapproved lot of Sucraid. Please see the latest drug shortage posting for individual lot information: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sacrosidase (Sucraid) Oral Solution&st=c&tab=tabs-1.
FDA is making this exception to distribute an unapproved lot of Sucraid so that patients with severe congenital sucrase-isomaltase deficiency (CSID) whose disease cannot be managed with diet alone can have access to the drug. FDA recommends that health care providers prioritize access to the drug for these patients and for patients with evidence of malnutrition.
Patients and health care providers should be aware that the released lot was manufactured at an unapproved facility under conditions that did not meet FDA’s standards for pharmaceuticals. Product from this lot may contain bacterial byproducts that could cause food poisoning-like illness, which is a safety concern, particularly in patients with weakened immune systems. Patients and health care providers should evaluate and discuss the potential risks of this product against the benefits and any alternate treatments. FDA remains concerned about QOL’s production process and the company’s ability to consistently produce safe and reliable product.
Alleviating the Sucraid shortage is a priority for FDA, and the Agency continues to work closely with the manufacturer to provide assistance needed to mitigate the shortage and to resolve remaining manufacturing issues. As with all drugs, FDA’s primary concern is that patients have products that are safe and effective for their intended uses and are manufactured to a high standard of quality.
Questions and Answers:
Posted 5/22/15, Updated 5/13/16, 4/26/2017, 11/20/2017, 5/2/2018
Q: What is Sucraid and what does it treat?
A: Sucraid (sacrosidase) oral solution is used for the treatment of symptoms associated with sucrose ingestion in patients with a rare gastrointestinal genetic disease called congenital sucrase-isomaltase deficiency (CSID). Patients with CSID cannot metabolize sucrose or starch, and they experience symptoms such as diarrhea, abdominal pain, bloating, and abdominal distention from the excessive fermentation of undigested carbohydrates. A subset of patients, often the younger patients, may present with dehydration or evidence of malabsorption, such as failure to thrive or signs of micronutrient deficiencies. Sucraid does not enable the metabolism of starch, so CSID patients still need to avoid starch in order to avoid digestive problems while taking Sucraid.
Q: Why is Sucraid posted on the FDA Drug Shortages: Additional News and Information page?
A: FDA is notifying prescribers, patients and their families that there is currently a limited supply of Sucraid, so they will have the opportunity to plan how to appropriately manage the remaining supply.
Q: Will supply of Sucraid run out?
A: We are working closely with QOL Medical, LLC, the company that manufactures Sucraid on the supply. There is currently a limited supply on hand. Therefore, FDA recommends that health care practitioners prioritize access of the remaining supply for patients with severe CSID, whose disease cannot be managed with diet alone (e.g., infants and toddlers) and for patients with evidence of malnutrition.
Q: Where can we obtain Sucraid? Are there any other suppliers?
A: Sucraid is available only by prescription, and QOL Medical, LLC is the sole supplier. There are no other approved suppliers. Please promptly report distribution of Sucraid by other suppliers to DRUGSHORTAGES@cder.fda.gov.
Q: Is this limited supply of Sucraid going to be long term? When will supply be back to normal?
A: We will continue to monitor the shortage and take steps as appropriate to address the supply issues FDA is working closely with QOL Medical, LLC on the supply and manufacturing concerns and will update the Drug Shortage Web site as information becomes available. Please contact QOL Medical, LLC directly for further information.
Q: Are there any other drug products that can be taken if there is a supply interruption of Sucraid?
A: There is no other product that has been approved by the FDA to treat CSID. In some CSID patients, the disease can be managed by diet, by avoiding sucrose and sucrose-containing foods and medicines, as well as by avoiding starch.
Q: What do I do if I and/or my child(ren) need Sucraid?
A: Please contact your physician as soon as possible to review and discuss this information regarding limited available supply, in order to assure ongoing access to the drug for patients with severe disease that can’t be managed with diet alone (e.g., infants and toddlers) and for patients with evidence of malnutrition.