[Posted 02/14/2014]

AUDIENCE: Medical Geneticist, Pediatrics, Pharmacy

ISSUE: FDA is notifiying health care professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. FDA has received adverse event reports associated with potentially subpotent L-citrulline. Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.

In addition to the identified lot number 96453, FDA is investigating reports that may include additional lot numbers.

BACKGROUND:Medisca supplies pharmacies nationwide with L-citrulline. The product is sold to pharmacies and clinics in containers filled with powdered L-citrulline, and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder.

RECOMMENDATION: FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information.

Patients should contact their physician or health care provider if they have concerns about the use of L-citrulline.

FDA asks health care professionals, patients, and caregivers to report adverse reactions or quality problems experienced with the use of L-citrulline packed by any companies, including Medisca, to the FDAs MedWatch Adverse Event Reporting program:

[02/14/2014 - Statement - FDA]