The U.S. Food and Drug Administration (FDA) has warned on Saturday that certain lots of Medisca's L-citrulline supplement, which is used to treat a rare but potentially life-threatening genetic disorder that primarily afflicts children, do not contain the crucial drug.
Medisca, a pharmacy compounding firm based in Plattsburgh, New York, has already taken steps to recall eight lots of the supplement, saying that these pose potential health hazards and should not be used for any purpose. The FDA, on the other hand, has advised doctors and patients not to use the fake supplement, which is available in hospitals and retail pharmacies throughout the country, and to report unwanted reactions and quality problems with any L-citrulline product.
"FDA alerts health care professionals and patients that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline," the agency said in a statement. "Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc."
L-citrulline is used for treating certain urea cycle disorders, a rare genetic disorder that often affects children and is characterized by a deficiency in an enzyme responsible for clearing ammonia from the blood. Ammonia builds up without enough L-citrulline and this could cause brain damage and even death. Of the approximately 2,500 children in the U.S with urea cycle disorders, about 75 percent require L-citrulline supplements.
Cynthia Le Mons, executive director of the National Urea Cycle Disorders Foundation (NUCDF) in Pasadena, California reported that at least six children have encountered problems with excess ammonia in their blood regardless of taking what they believed was adequate L-citrulline medication. A 14-year old girl, for instance, suffered from stomach pains, experienced massive hair loss and needed to be hospitalized for having high levels of ammonia in her blood, Le Mons reported.
Medisca conducted an investigation and found that its L-citrulline supplements with lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D did not contain L-citrulline. The company has voluntarily recalled the products with these lot numbers but there may still be other affected lot numbers.
"FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information," the FDA said. "FDA has received several adverse event reports associated with Medisca's L-citrulline product. FDA is investigating reports that may include additional lot numbers, continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available."
