Gonorrhea Treatment Options Hang by a Thread

SAN DIEGO – Resistance to gonorrhea 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 cephalo-sporins [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 the treatment of gonorrhea, which is 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 the treatment of 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; however, it is currently unavailable in the United States, except in a liquid pediatric formula approved last year.

One 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, which were once marketed as Suprax, when the drug's patent expired in 2002.

Exclusive rights to the drug are now held by a company that is based in India. She said it is rumored that the company is 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 who are 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, said Dr. Marrazzo, who added that the suggestion is impractical for a busy clinic.

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

If fluoroquinolones are the only remaining option in cephalosporin-allergic patients, then Dr. Marrazzo recommends that one obtain a culture before treatment to ensure sensitivity, or that one obtain 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 Co. and she serves on the speakers' bureaus of 3M and Merck. FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS. are published by the International Medical News Group, which is a division of Elsevier.

SAN DIEGO – Resistance to gonorrhea 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 cephalo-sporins [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 the treatment of gonorrhea, which is 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 the treatment of 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; however, it is currently unavailable in the United States, except in a liquid pediatric formula approved last year.

One 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, which were once marketed as Suprax, when the drug's patent expired in 2002.

Exclusive rights to the drug are now held by a company that is based in India. She said it is rumored that the company is 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 who are 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, said Dr. Marrazzo, who added that the suggestion is impractical for a busy clinic.

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

If fluoroquinolones are the only remaining option in cephalosporin-allergic patients, then Dr. Marrazzo recommends that one obtain a culture before treatment to ensure sensitivity, or that one obtain 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 Co. and she serves on the speakers' bureaus of 3M and Merck. FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS. are published by the International Medical News Group, which is a division of Elsevier.

SAN DIEGO – Resistance to gonorrhea 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 cephalo-sporins [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 the treatment of gonorrhea, which is 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 the treatment of 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; however, it is currently unavailable in the United States, except in a liquid pediatric formula approved last year.

One 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, which were once marketed as Suprax, when the drug's patent expired in 2002.

Exclusive rights to the drug are now held by a company that is based in India. She said it is rumored that the company is 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 who are 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, said Dr. Marrazzo, who added that the suggestion is impractical for a busy clinic.

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

If fluoroquinolones are the only remaining option in cephalosporin-allergic patients, then Dr. Marrazzo recommends that one obtain a culture before treatment to ensure sensitivity, or that one obtain 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 Co. and she serves on the speakers' bureaus of 3M and Merck. FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS. are published by the International Medical News Group, which is a division of Elsevier.