Government health officials are warning pharmacies and patients about fake lots of a supplement used to treat potentially life-threatening genetic disorders diagnosed primarily in children.
Food and Drug Administration officials said on Saturday that lots of the supplement L-citrulline sold by the compounding firm Medisca were found not to contain the drug at all. The company, based in Plattsburgh, N.Y., voluntarily recalled eight lots of the supplement, which is supplied to hospital and retail pharmacies nationwide.
“Health care professionals should discontinue dispensing from these lots, contact patients and return all unused product to Medisca Inc.,” FDA officials said in a notice.
L-citrulline is an amino acid used to treat certain urea cycle disorders, a genetic problem in which the body lacks one of six enzymes that help clear ammonia from the blood. Without enough L-citrulline, the ammonia builds up, potentially causing life-threatening brain damage and death.
Medisca officials said they had contacted their manufacturer, but have not identified what material may have been substituted for the L-citrulline.
But at least a half dozen children nationwide have reported problems resulting from low levels of the supplement, despite taking what they believed was adequate medication, said Cynthia Le Mons, executive director of the National Urea Cycle Disorders Foundation in Pasadena, Calif.
One 14-year-old girl had huge clumps of her hair fall out, suffered stomach pains and had to be hospitalized because of high levels of ammonia in her blood, said Le Mons. There are other suppliers of L-citrulline, but Medisca is a primary source, she said.
Urea cycle disorders are rare, affecting between 2,000 and 2,500 children in the U.S., Le Mons said. About 75 percent of those people may require L-citrulline supplements.
Medisca has had troubles with its drugs in the past. In 2012, the company and its founder were sentenced in U.S. district court in New York to pay a $15,000 fine and forfeit $1.7 million in profits for unlawful sale of human growth hormone drugs imported from China.
First published February 15 2014, 12:52 PM