Particulate Matter Found in Ammonul Injection

Yael Waknine

Disclosures

September 23, 2008

September 23, 2008 — Particulate matter has been detected in sodium phenylacetate plus sodium benzoate injection (Ammonul, Ucyclyd Pharma, Inc), the US Food and Drug Administration (FDA) warned healthcare professionals today.

Because the particles may not be visible on inspection, clinicians are being advised to use a Millex Durapore GV 33-mm sterile syringe filter (0.22 μm) when injecting the product into the 10% dextrose intravenous bag.

Testing has confirmed the removal of this specific particulate when the filter is used during the admixture process, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program. In a communication to healthcare professionals, the company notes that syringes will be supplied with the product until further notice.

Sodium phenylacetate plus sodium benzoate injection is indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with urea cycle-enzyme deficiencies.

Adverse events related to use of sodium phenylacetate plus sodium benzoate injection should be reported to the manufacturer by telephone 24 hours a day, 7 days a week, at 1-800-900-6389. Alternatively, case data may be relayed to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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