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Notice to Readers: Discontinuation of Spectinomycin

In January 2006, CDC learned that Pfizer, Inc. (New York, New York) had discontinued U.S. distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory will expire in May 2006. No other pharmaceutical company manufactures or sells spectinomycin in the United States. Pfizer is continuing to distribute spectinomycin outside the United States for the international market. CDC and the Food and Drug Administration are working with Pfizer to make spectinomycin available again in the United States and will update this information as soon as possible.

Historically, spectinomycin has been used to treat persons infected with Neisseria gonorrhoeae who cannot receive one of the two first-line treatments (i.e., fluoroquinolones or third-generation cephalosporins) currently recommended for treatment of uncomplicated gonococcal infection (1). Relatively few indications exist for which spectinomycin is the preferred treatment option for N. gonorrhoeae; these include 1) pregnant women with penicillin or cephalosporin allergy (fluoroquinolones are contraindicated during pregnancy), 2) persons with penicillin or cephalosporin allergies who reside in areas with a high prevalence of quinolone-resistant N. gonorrhoeae (1,2), and 3) men with penicillin or cephalosporin allergies who have sex with men (3). No acceptable alternatives to spectinomycin therapy are currently available. Persons with penicillin or cephalosporin allergies who cannot receive fluoroquinolones can be desensitized to cephalosporins before treatment (4). Although 2 grams of azithromycin orally in a single dose is effective against uncomplicated gonococcal infection, no data are available to assess the safety and efficacy of this regimen in pregnant women. Moreover, concerns exist regarding the emergence of antimicrobial resistance if azithromycin is used widely in the treatment of N. gonorrhoeae.

References

  1. CDC. Sexually transmitted diseases treatment guidelines 2002. MMWR 2002;51(No. RR-6).
  2. CDC. Increases in fluoroquinolone-resistant Neisseria gonorrhoeae---Hawaii and California, 2001. MMWR 2002;51:1041--4.
  3. CDC. Increases in fluoroquinolone-resistant Neisseria gonorrhoeae among men who have sex with men---United States, 2003, and revised recommendations for gonorrhea treatment, 2004. MMWR 2004;53:335--8.
  4. Park Miguel A, Li JTC. Diagnosis and management of penicillin allergy. Mayo Clin Proc 2005;80:405--10.



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