title: Determination of levamisole in urine by gas chromatography-mass spectrometry.
abstract: The United States Public Health Service Substance Abuse and Mental Health Services Administration is alerting medical professionals that a substantial percentage of cocaine imported into the United States is adulterated with levamisole, a veterinary pharmaceutical that can cause blood cell disorders such as severe neutropenia and agranulocytosis. Levamisole HCl is the active ingredient in a number of veterinary drugs approved to treat worm infestations in animals. Levamisole HCl was also the active ingredient in a human drug for oral administration approved on June 18, 1990, as adjuvant treatment in combination with fluorouracil after surgical resection in patients with Duke's stage C colon cancer. This drug was withdrawn from the U.S. market around 2000, and it has not been marketed in the U.S. since then. The objective of this study was to develop a method to determine the amount of levamisole in urine samples. The procedure will be provided to state health laboratories as needed to be used in the evaluation of patients that have developed neutropenia or agranulocytosis in the setting of recent cocaine use. A gas chromatography-mass spectrometry method was validated and tested at two different laboratories, and the method limit of detection for levamisole is 1 ng/mL in urine when using a 5-mL sample. Confirmation of the stereoisomer of levamisole was done by high-performance liquid chromatography using a chiral column.
authors: U.S. FDA/CDER/DPA, 1114 Market Street, St. Louis, Missouri 63101, USA.
authors: Michael L
authors: ML
authors: Trehy
authors: Daniel J
authors: DJ
authors: Brown
authors: Jeffrey T
authors: JT
authors: Woodruff
authors: Benjamin J
authors: BJ
authors: Westenberger
authors: William G
authors: WG
authors: Nychis
authors: Nicholas
authors: N
authors: Reuter
authors: Joshua G
authors: JG
authors: Schier
authors: Sara J
authors: SJ
authors: Vagi
authors: Rong-Jen
authors: RJ
authors: Hwang
mesh_terms: D000380:Agranulocytosis / Q000139:chemically induced; D002138:Calibration; D003042:Cocaine / Q000737:chemistry / Q000652:urine*; D019970:Cocaine-Related Disorders / Q000175:diagnosis* / Q000652:urine; D004340:Drug Contamination; D008401:Gas Chromatography-Mass Spectrometry / Q000592:standards; D006801:Humans; D013287:Illicit Drugs / Q000737:chemistry / Q000652:urine*; D007978:Levamisole / Q000009:adverse effects / Q000652:urine*; D057230:Limit of Detection; D009503:Neutropenia / Q000139:chemically induced; D015203:Reproducibility of Results; D015813:Substance Abuse Detection / Q000379:methods* / Q000592:standards; D014481:United States; D019155:Veterinary Drugs / Q000009:adverse effects / Q000652:urine*
chemical_list: D013287:Illicit Drugs; D019155:Veterinary Drugs; D007978:Levamisole; D003042:Cocaine