Recalls

Testing reveals genetic disorder treatment contains wrong drug ingredient

fda logo Testing reveals genetic disorder treatment contains wrong drug ingredientA Food and Drug Administration (FDA) analysis of recalled lots of Medisca’s L-citrulline, a drug used to treat certain urea cycle disorders, a rare genetic disorder primarily diagnosed in children, revealed that the samples contained N-acetyl-leucine, a product used to treat a certain type of dizziness known as acute vestibular vertigo. No L- citrulline was found in the samples tested by the FDA.

The recall was initiated last week after the FDA received reports of adverse events associated with subpotent L-citrulliine in patients who were administered the drug. Subpotent L-citurlline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life threatening.

Affected L-citrulline lots include numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D.

The FDA alerted health care professionals and patients that a recall has been issued. Health care professionals have been asked to discontinue dispensing affected lots of this product, contact patients, and return all unused products to Medisca. Patients and caregivers should stop using affected lots of this product immediately.

The FDA is continuing to investigate reports that may include additional lot numbers. The agency will continue to provide additional information as it becomes available.

Any side effects from use of this drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA