Ammonul Injection Warning Issued by FDA

The FDA and Ucyclyd Pharma, Inc., a fully owned subsidiary of Medicis Pharmaceutical Corp., have issued warnings to hospital emergency doctors, nursing personnel and risk managers advising that Ammonul injection products may include particulate matter that could affect the safety of the drug.

The manufacturer recently detected the presence of particulate matter in the Ammonul injection products, which requires healthcare providers to take special steps to ensure the safe use of the drug.

The warning indicates that a Millex Durapore GV 33 mm sterile syringe filter (0.22/lm) should be used in the course of the admixture process, prior to injecting Ammonul into the 10% Dextrose IV bag.

Ammonul is a combination of sodium benzoate and sodium phenylacetate, which causes less ammonia to be produced by the body. It is used to treat hyperammonemia, a condition that results from high amounts of ammonia in the blood, which could potentially lead to a brain injury known as encephalopathy, or death.

Ucyclyd Pharma, Inc. warns that the particulate matter may not be readily seen, and the sterile syringe filter should be used in all cases, regardless of whether the particulate matter is seen in the vial.

Particulate matter (PM), referred to as “a mixture of mixtures”, can be solids like soot, ash or dust. It can also take the form of suspended solids in mixtures of liquid or fully liquid aerosols.

Particle pollution causing particulate matter can result in death from cardiovascular causes, including strokes. An increased risk of heart attacks could be caused by particulate matter, especially among the elderly and those with heart problems. Particulate matter has also been associated with increased hospitalization in young children with asthma, inflammation of lung tissue in young and healthy adults, and a higher incidence of asthma attacks in children.

The FDA and drug maker indicate that testing has confirmed that the use of the sterile syringe filter extracted the particulate matter when used before the ad-mix of the Ammonul injection.

In a letter sent to healthcare providers, Ucyclyd indicates that they will distribute Millex Durapore GV 33 mm sterile syringe filters along with all shipments of their Ammonul products as a precautionary measure until further notice.