Gonorrhea Drug Resistance Could Lead to Crisis

SAN DIEGO — Resistance to gonorrhea drugs is climbing just as treatment options are dwindling, making for a potential public health crisis if more drug choices are not brought to market soon.

“The situation is really not good. We're hanging by a thread, with a very serious resistance problem. If we lose cephalosporins [to resistance], we will really be up a creek,” Dr. Jeanne Marrazzo said at Perspectives in Women's Health, sponsored by FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS.

Practically speaking, ceftriaxone (125 mg intramuscularly, in a single dose) remains the only available regimen recommended by the Centers for Disease Control and Prevention for treating gonorrhea, the second-most commonly reported infectious disease in the United States.

After years of decline or stability, U.S. rates of gonorrhea rose for the second straight year in 2006, with about 358,000 new cases reported, according to CDC surveillance statistics.

Many infectious disease specialists are wary of dependence on a single drug to treat a widespread infectious disease because of the threat of resistance, and gonorrhea seems particularly susceptible.

Widespread resistance long ago took penicillins, sulfa drugs, tetracycline, and spectinomycin off the table for gonococcal infections; by April of last year, fluoroquinolones, including ciprofloxacin, ofloxacin, and levofloxacin, also lost their “recommended” status because of resistance documented in sites in the United States and other countries.

Cefixime remains on the CDC's recommended list; it is currently unavailable in the United States, except in a liquid pediatric formula approved last year. A problem with the pediatric formula is that it has a limited shelf life once reconstituted.

Dr. Marrazzo explained that Wyeth Pharmaceuticals discontinued manufacture of cefixime tablets, once marketed as Suprax, when the patent for the medication expired in 2002.

Exclusive rights to the drug are now held by a company based in India, which is rumored to be working with the Food and Drug Administration to obtain approval to market 400-mg tablets in the United States.

Alternative regimens suggested by the CDC include spectinomycin, which is also no longer being manufactured in the United States, and single-dose cephalosporin regimens.

All patients with gonorrhea should be cotreated for chlamydia unless it is ruled out with a highly sensitive test.

The lack of availability of spectinomycin complicates management of patients allergic to cephalosporins, according to Dr. Marrazzo of the Seattle STD/HIV Prevention Training Center and the University of Washington, Seattle. The CDC “cluelessly” recommends desensitizing patients, a suggestion she considers impractical in a busy clinic.

Such cases might call for special consideration of high-dose azithromycin, but the 2-g dose required can cause gastrointestinal problems, even with split doses administered several hours apart. In any case, resistance to azithromycin is likely increasing, so “that's going to be a short-term fix.”

If fluoroquinolones are the only remaining option in cephalosporin-allergic patients, Dr. Marrazzo recommends obtaining a culture before treatment to ensure sensitivity, or obtaining a test of cure in 3–5 days by culture or 3 weeks if a nucleic acid amplification test is used.

Dr. Marrazzo disclosed that she is a consultant to Mission Pharmacal, and serves on the speakers bureaus of 3M and Merck & Co. INTERNAL MEDICINE NEWS is published by International Medical News Group, a division of Elsevier.

A cervical smear photomicrograph shows extracellular diplococci determined to be Neisseria gonorrhoeae bacteria. CDC/Joe Miller

SAN DIEGO — Resistance to gonorrhea drugs is climbing just as treatment options are dwindling, making for a potential public health crisis if more drug choices are not brought to market soon.

“The situation is really not good. We're hanging by a thread, with a very serious resistance problem. If we lose cephalosporins [to resistance], we will really be up a creek,” Dr. Jeanne Marrazzo said at Perspectives in Women's Health, sponsored by FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS.

Practically speaking, ceftriaxone (125 mg intramuscularly, in a single dose) remains the only available regimen recommended by the Centers for Disease Control and Prevention for treating gonorrhea, the second-most commonly reported infectious disease in the United States.

After years of decline or stability, U.S. rates of gonorrhea rose for the second straight year in 2006, with about 358,000 new cases reported, according to CDC surveillance statistics.

Many infectious disease specialists are wary of dependence on a single drug to treat a widespread infectious disease because of the threat of resistance, and gonorrhea seems particularly susceptible.

Widespread resistance long ago took penicillins, sulfa drugs, tetracycline, and spectinomycin off the table for gonococcal infections; by April of last year, fluoroquinolones, including ciprofloxacin, ofloxacin, and levofloxacin, also lost their “recommended” status because of resistance documented in sites in the United States and other countries.

Cefixime remains on the CDC's recommended list; it is currently unavailable in the United States, except in a liquid pediatric formula approved last year. A problem with the pediatric formula is that it has a limited shelf life once reconstituted.

Dr. Marrazzo explained that Wyeth Pharmaceuticals discontinued manufacture of cefixime tablets, once marketed as Suprax, when the patent for the medication expired in 2002.

Exclusive rights to the drug are now held by a company based in India, which is rumored to be working with the Food and Drug Administration to obtain approval to market 400-mg tablets in the United States.

Alternative regimens suggested by the CDC include spectinomycin, which is also no longer being manufactured in the United States, and single-dose cephalosporin regimens.

All patients with gonorrhea should be cotreated for chlamydia unless it is ruled out with a highly sensitive test.

The lack of availability of spectinomycin complicates management of patients allergic to cephalosporins, according to Dr. Marrazzo of the Seattle STD/HIV Prevention Training Center and the University of Washington, Seattle. The CDC “cluelessly” recommends desensitizing patients, a suggestion she considers impractical in a busy clinic.

Such cases might call for special consideration of high-dose azithromycin, but the 2-g dose required can cause gastrointestinal problems, even with split doses administered several hours apart. In any case, resistance to azithromycin is likely increasing, so “that's going to be a short-term fix.”

If fluoroquinolones are the only remaining option in cephalosporin-allergic patients, Dr. Marrazzo recommends obtaining a culture before treatment to ensure sensitivity, or obtaining a test of cure in 3–5 days by culture or 3 weeks if a nucleic acid amplification test is used.

Dr. Marrazzo disclosed that she is a consultant to Mission Pharmacal, and serves on the speakers bureaus of 3M and Merck & Co. INTERNAL MEDICINE NEWS is published by International Medical News Group, a division of Elsevier.

A cervical smear photomicrograph shows extracellular diplococci determined to be Neisseria gonorrhoeae bacteria. CDC/Joe Miller

SAN DIEGO — Resistance to gonorrhea drugs is climbing just as treatment options are dwindling, making for a potential public health crisis if more drug choices are not brought to market soon.

“The situation is really not good. We're hanging by a thread, with a very serious resistance problem. If we lose cephalosporins [to resistance], we will really be up a creek,” Dr. Jeanne Marrazzo said at Perspectives in Women's Health, sponsored by FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS.

Practically speaking, ceftriaxone (125 mg intramuscularly, in a single dose) remains the only available regimen recommended by the Centers for Disease Control and Prevention for treating gonorrhea, the second-most commonly reported infectious disease in the United States.

After years of decline or stability, U.S. rates of gonorrhea rose for the second straight year in 2006, with about 358,000 new cases reported, according to CDC surveillance statistics.

Many infectious disease specialists are wary of dependence on a single drug to treat a widespread infectious disease because of the threat of resistance, and gonorrhea seems particularly susceptible.

Widespread resistance long ago took penicillins, sulfa drugs, tetracycline, and spectinomycin off the table for gonococcal infections; by April of last year, fluoroquinolones, including ciprofloxacin, ofloxacin, and levofloxacin, also lost their “recommended” status because of resistance documented in sites in the United States and other countries.

Cefixime remains on the CDC's recommended list; it is currently unavailable in the United States, except in a liquid pediatric formula approved last year. A problem with the pediatric formula is that it has a limited shelf life once reconstituted.

Dr. Marrazzo explained that Wyeth Pharmaceuticals discontinued manufacture of cefixime tablets, once marketed as Suprax, when the patent for the medication expired in 2002.

Exclusive rights to the drug are now held by a company based in India, which is rumored to be working with the Food and Drug Administration to obtain approval to market 400-mg tablets in the United States.

Alternative regimens suggested by the CDC include spectinomycin, which is also no longer being manufactured in the United States, and single-dose cephalosporin regimens.

All patients with gonorrhea should be cotreated for chlamydia unless it is ruled out with a highly sensitive test.

The lack of availability of spectinomycin complicates management of patients allergic to cephalosporins, according to Dr. Marrazzo of the Seattle STD/HIV Prevention Training Center and the University of Washington, Seattle. The CDC “cluelessly” recommends desensitizing patients, a suggestion she considers impractical in a busy clinic.

Such cases might call for special consideration of high-dose azithromycin, but the 2-g dose required can cause gastrointestinal problems, even with split doses administered several hours apart. In any case, resistance to azithromycin is likely increasing, so “that's going to be a short-term fix.”

If fluoroquinolones are the only remaining option in cephalosporin-allergic patients, Dr. Marrazzo recommends obtaining a culture before treatment to ensure sensitivity, or obtaining a test of cure in 3–5 days by culture or 3 weeks if a nucleic acid amplification test is used.

Dr. Marrazzo disclosed that she is a consultant to Mission Pharmacal, and serves on the speakers bureaus of 3M and Merck & Co. INTERNAL MEDICINE NEWS is published by International Medical News Group, a division of Elsevier.

A cervical smear photomicrograph shows extracellular diplococci determined to be Neisseria gonorrhoeae bacteria. CDC/Joe Miller