Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) is urging health care professionals to always recheck their dosing calculations prior to administering Arginine Hydrochloride Injections and to be aware that several unlabeled adverse events may be associated with the use of the drug, according to the Postmarket Reviews section of the Volume 2, Number 2 2, 2009 issue of its quarterly online newsletter, Drug Safety News (DSN).

The findings are from a post-market safety review of arginine hydrochloride (HCL) injection (marketed as R-Gene 10), a diagnostic drug used to evaluate pituitary function, which identified several reports of medication errors and other adverse events associated with the drug. The events were reported to the FDA’s Adverse Events Reporting System (AERS) and included four cases of fatal overdose in pediatric patients, instances of serious injection site and hypersensitivity reactions (which were previously noted on the medication’s label), and several cases of hematuria (an unlabeled event). Hematuria is the presence of blood in the urine, a possible sign of abnormal bleeding.

Arginine HCL injection has been approved by the FDA since 1973 to stimulate the pituitary gland in order to evaluate release of human growth hormone (HGH). Since 1973, the FDA has received seven reports of medication errors associated with the use of arginine HCL injection. Most medication errors resulted in an overdose of the drug in a pediatric patient, including four that resulted in death.

In a separate review of the medication, AERS identified 33 other adverse reports associated with arginine HCL. In particular, AERS identified several cases of hematuria in patients who had received an infusion of arginine HCL. Hematuria was not listed as a possible adverse event on the product’s label.

The FDA encourages health care professionals to report any suspected arginine HCL-associated adverse events to the FDA’s MedWatch Program.

Source: FDA

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