New York-based compounding firm Medisca issued a voluntary recall of certain lot numbers of its L-citrulline supplement and warned consumers to be on alert for potential problems.
Prescription drug watchdogs are keeping an eye on future stocks of L-citrulline following a warning by the U.S. Food and Drug Administration (FDA) about defective batches of the supplements. The FDA issued an alert in early 2014 after the manufacturer recalled batches of the supplement that were compounded improperly and yet sent out to hospitals, clinics and retail pharmacies.
Doctors prescribe L-citrulline, an amino acid, to treat rare and serious genetic disorders that most frequently affect children. Without the supplement, these children may build up an overload of ammonia. That overload can cause severe side effects, including death.
Medisca Inc., a compounding firm based in Plattsburgh, N.Y., supplies L-citrulline to all parts of the United States. The company sells the supplement to hospitals, clinics and retail pharmacies in powder form. From there, the supplement can be compounded into capsules, tablets or liquids for consumers.
Medisca Recalls Bad Lots
The FDA’s actions came after it received several reports of adverse events about the L-citrulline, but the FDA did not order a recall. Instead, the recall came from Medisca, and it was voluntary. Medisca recalled eight lots of its L-citrulline product on Feb. 14, 2014. An investigation by the company indicated that the recalled lots did not contain any L-citrulline. The possibility of people taking the inactive supplements represented a potential health hazard.
Medisca asked that the defective lots not be used for any purpose. It asked hospital and retail pharmacies to check existing stocks for these products and lot numbers:
- 1 kg size:Lot numbers 96453/A and 95482/A in 2.8 L white HDPE bottles
- 500 g size: Lot numbers 96453/B and 95482/B in 1000 mL white HDPE bottles
- 100 g size: Lot numbers 96453/C and 95482/C in 300 mL white HDPE bottles
- 25 g size: Lots numbers 96453/D and 95482/D in 100 mL white HDPE bottles
The company asked hospitals and pharmacies that if any of these recalled products are found that they be returned to Medisca. The company also asked distributors to contact customers, including individual patients, to alert them about the defective supplements and the recall and to ask for returns of any unused products.
Medisca asked its customers and supplement users to report any adverse events.
FDA: Defective L-Citrulline Supplements Pose a Threat to Children
The FDA’s concern about the defective lots stems from the danger that could occur. Primary users of pharmaceutical-grade L-citrulline products from Medisca and other manufacturers are children diagnosed with certain urea cycle disorders. These conditions are characterized by a deficiency in one of six enzymes that aid in clearing ammonia from the body, which accumulates in the bloodstream as a byproduct of normal metabolic function. L-citrulline can be a life-saving medication for these children, helping their bodies eliminate ammonia from the bloodstream and preventing it from accumulating to toxic levels.
According to the National Urea Cycle Disorders Foundation, side effects can include metabolic instability and hyperammonemia – abnormally high ammonia levels in the body.
High ammonia levels can lead to:
- Brain damage
In its safety alert, the FDA said it had received adverse event reports associated with potentially sub-potent L-citrulline. This sub-potency in patients with certain urea cycle defects can lead to high ammonia levels, a condition that is serious and potentially life-threatening. The agency advised that health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca.
In an update to that safety alert, released on Feb. 17, 2014, the FDA said that after testing samples from the recalled lots of Medisca's L-citrulline product, the agency found that the faulty lots contained no L-citrulline at all. Instead, they contained N-acetyl-leucine, another amino acid that is used to treat vertigo.
In light of these findings, FDA updated its recommendations to health care professionals, advising them to focus attention on following up with patients who are at greatest risk from these mislabeled products.