The U.S. Food and Drug Administration (FDA) has issued a ban on certain batches of a L-citrulline supplement produced by Medisca Inc, a leading pharmacy compounding supplier.
The FDA has warned other pharmacies and patients from using eight lots of L-citrulline supplement that do not contain the amino acid used to treat rare genetic and urea cycle disorders found primarily in children. The lot numbers 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C and 96453/D don't contain L-citrulline, states the FDA report.
"Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc. Patients and caregivers should stop using any product with these lot numbers," the FDA said in a press release.
Low levels of L-citrulline results in excess ammonia in the blood and may lead to brain damage and even death.
After testing the specified lots, the New York-based compounding firm found that none of the products contained L-citrulline. As a result, the company has voluntarily recalled the supplements and issued warnings, stating the health hazards that may be caused by the deficient supplement. The company also stated that they have already informed their manufacturing partner to make up for the deficiency.
The drug loss in the supplement has affected more than half dozen a children, claimed Cynthia Le Mons, executive director of the National Urea Cycle Disorders Foundation, reports Medical Daily. One 14-year girl was hospitalized on account of a deficiency of L-citrulline after she lost clumps of hair and experienced severe stomach pain.
The FDA is further investigating the matter and said it will continue to provide more information as it becomes available.
