Treatment options expand for gonorrhea
The woman in your exam room says she is experiencing a painful, burning sensation when urinating, and reports increased vaginal discharge. The test is positive for gonorrhea. What's your next move?
A single dose of cefixime 400 mg tablets is the only oral treatment for uncomplicated gonorrhea of the cervix, urethra, or rectum recommended by the Centers for Disease Control and Prevention (CDC); however, tablets of the drug have been unavailable in the United States since 2002.
The recent renewed availability of cefixime 400 mg tablets increases clinicians' options to treat gonorrhea, one of the most common sexually transmitted diseases (STDs) in the United States. Since April 2007, the CDC has advised providers not to use fluoroquinolones such as ciprofloxacin, ofloxacin, and levofloxacin for the treatment of gonorrhea, based on data indicating widespread drug resistance in the United States.1
When Wyeth Pharmaceuticals in Collegeville, PA, discontinued manufacturing cefixime tablets in 2002, clinicians were limited in their treatment options, since the CDC's recommended treatment options for gonorrhea are limited to a single class of antibiotics, the cephalosporins. The CDC recommends ceftriaxone, available only as an injection, for all types of gonorrhea infection, including genital, anal, and pharyngeal. Cefixime is recommended for genital and rectal gonorrhea.2
While Baltimore-based Lupin Pharmaceuticals received Food and Drug Administration (FDA) approval to manufacture and market cefixime in 2004, it has had only an oral suspension form available. The company now has Suprax 400 mg tablets available with wholesalers, ready for ordering by pharmacies as well as clinics, says Atul Gokhale, Lupin Pharmaceuticals' general manager of marketing. Public health service pricing is available on the Suprax tablets, says William Chase, director of Lupin Pharmaceuticals' trade and managed markets. While pricing is available through the company's customer service line, (866) 587-4617, orders should be placed through clinics' primary wholesalers, says Chase.
Tablet offers option
What does the addition of cefixime tablets represent in the current efforts to curb gonorrhea rates in the United States?
The return of cefixime tablets to U.S. pharmacies is a great assistance in the fight to control the STD, says Lori Newman, MD, a medical epidemiologist with the CDC's Division of STD Prevention. Having an oral option allows treatment of gonorrhea in settings where injections are not feasible and provides patients with a drug that is easier to take, she notes.
The CDC is calling for increased vigilance against gonorrhea. Following a 74% decline in the rate of reported cases from 1975 through 1997, overall gonorrhea rates plateaued, then increased for the past two years, the agency reports.3 In 2006, the gonorrhea rate was 120.9 cases per 100,000 population, representing an increase of 5.5% since 2005 and an increase for the second consecutive year.
"While the renewed availability of a gonorrhea drug in tablet form marks progress, there is still only one class of antibiotics currently recommended for the treatment of gonorrhea in the U.S.," says Newman. "More treatment options are needed to combat the spread of this disease, and CDC continues to call for the development of additional gonorrhea treatment options."
The addition of cefixime tablets to pharmacy shelves also gives clinicians another option in treating a non-STD urinary tract infection. The drug may be used for uncomplicated urinary tract infections caused by E. coli and P. mirabilis.
Use in expedited partner therapy?
The renewed availability of cefixime tablets in the United States will be good news for clinicians whose state laws allow for expedited partner therapy (EPT). In the case of gonorrhea treatment, EPT allows for the delivery of medications or prescriptions by persons infected with the STD to their sex partners. The CDC advises that EPT should not replace other routine notification activities and should not be used for men who have sex with men or partners who require clinical evaluation, such as those with symptoms. (Editor's note: Get more CDC information on EPT at its web page, www.cdc.gov/std/EPT.)
A recent report reviewed the legal permissibility of EPT in the United States.4 It used an examination of existing and prospective legislation and regulations, judicial decisions, and administrative opinions by attorneys general to provide its assessment.
According to the report's analysis:
- EPT is permissible in California, Colorado, Maryland, Minnesota, Mississippi, Nevada, New Mexico, Pennsylvania, Tennessee, Utah, Washington, and Wyoming.
- EPT is "potentially allowable" in Alabama, Alaska, Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Maine, Massachusetts, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Oregon, Puerto Rico, Rhode Island, South Dakota, Texas, Virginia, and Wisconsin.
- EPT is "probably prohibited" in Arizona, Arkansas, Florida, Illinois, Kentucky, Louisiana, Michigan, North Dakota, Ohio, Oklahoma, South Carolina, Vermont, and West Virginia.
References
- Centers for Disease Control and Prevention. Update to CDC's sexually transmitted diseases treatment guidelines, 2006: Fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR 2007; 56:332-336.
- Centers for Disease Control and Prevention, Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR 2006; 55(RR-11):1-94.
- Centers for Disease Control and Prevention. 2006 STD Surveillance Report. Accessed at www.cdc.gov.
- Hodge JG Jr, Pulver A, Hogben M, et al. Expedited partner therapy for sexually transmitted diseases: Assessing the legal environment. Am J Public Health 2008; 98:238-243.
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