Cefixime 400-mg Tablets Return to U.S. Market

Beginning this month, the only oral agent recommended by the CDC for treatment of uncomplicated urogenital or rectal gonococcal infection is again readily available in the United States. According to a notice in the April 25 Morbidity and Mortality Weekly Report, Baltimore-based Lupin Pharmaceuticals Inc. has begun manufacturing cefixime 400-mg tablets for distribution in the United States.

In an April 9 "Dear Colleague" letter, (1-page PDF; About PDFs) John Douglas Jr., M.D., director of the Division of STD Prevention at the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, announced the drug's return to the U.S. market, noting that "the renewed availability of cefixime in oral form is a positive step in controlling the spread of this serious disease that affects roughly 700,000 Americans each year."

The oral formulation had been in short supply since July 2002, when Wyeth Pharmaceuticals, of Collegeville, Pa., discontinued manufacturing the 400-mg tablets. Wyeth stopped making the tablets after losing the patent on its brand name cefixime product, Suprax.

Wyeth continued to sell existing stores of its cefixime suspension, a 100-mg/5-ml formulation, until the end of the first quarter of 2003. It wasn't until the following year that any other manufacturer -- in this case, Lupin Pharmaceuticals -- sought FDA approval to market cefixime. Lupin has been manufacturing and marketing cefixime oral suspension (100-mg/5-mL) since February 2004 and cefixime oral suspension (200-mg/5-mL) since April 2007.

Meanwhile, the incidence of new gonococcal infections in the United States has seen some significant ups and downs in recent years, according to an STD surveillance report from the CDC. After a 74 percent decline in the rate of reported gonorrhea from 1975 through 1997, overall infection rates plateaued, but recently, they have begun inching upward again. In 2006, the gonorrhea rate was 120.9 cases per 100,000 persons, an increase of 5.5 percent compared with 2005 and the second consecutive year in which rates increased.

"Like chlamydia, gonorrhea is substantially underdiagnosed and underreported, and approximately twice as many new infections are estimated to occur each year as are reported," that report noted.

A CDC announcement last spring further complicated the picture, when CDC health officials called on clinicians to no longer use fluoroquinolones to treat gonococcal infections and associated conditions, such as pelvic inflammatory disease. That move -- made in response to the increasing prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae throughout the United States -- left the cephalosporins as the sole recommended treatment options for infections caused by N. gonorrhoeae.

In updated recommendations issued at that time, the CDC called for the use of ceftriaxone, available only as an injection, as a first-line treatment for all types of gonorrhea -- anal, genital and pharyngeal. A single 400-mg dose of cefixime, in tablet or suspension form, remains the standard oral therapy for uncomplicated urogenital or rectal gonococcal infection.

For information on how to obtain cefixime, clinicians can contact Lupin Pharmaceuticals at (866) 587-4617