The Food and Drug Administration (FDA) has issued a notice of limited availability of STI testing and treatment products.

A recent shortage of penicillin G benzathine injectable suspension products (Bicillin L-A®) could cause some disruption in the treatment of pregnant people, others with syphilis, and the sexual contacts of these patients. Current estimates predict this shortage will last into 2024. Please note the amount of treatment you currently have on hand to set a prioritization for using penicillin or doxycycline as an alternative. Doxycycline 100mg PO BID for two weeks (for early syphilis) or four weeks (for late latent or syphilis of unknown duration) is an alternative for treating non-pregnant people with a penicillin allergy.

On July 23, 2021, the FDA reported a shortage of gentamicin sulfate injection (80mg per 2ml). In combination with azithromycin, gentamicin is an alternative regimen for use if ceftriaxone is unavailable for uncomplicated gonococcal infection of the cervix, urethra, or rectum among adults and adolescents. In addition, gentamicin, combined with azithromycin, can be considered an alternative to ceftriaxone for persons with cephalosporin allergy.

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Information for prioritization of penicillin treatment

Patients with certain characteristics and in certain clinical contexts should be prioritized for penicillin treatment. In descending order of priority, these contexts are listed below:

1. Pregnant people can only be treated with penicillin. Doxycycline cannot be used for the treatment of pregnant people and therefore must be the highest priority.
2. People with primary or secondary syphilis only need one dose of penicillin.
3. People with early non-primary, non-secondary syphilis either demonstrated through a previous negative test or with contact to a known early case will only need one dose of penicillin.
4. Patients with late or unknown duration syphilis should have doxycycline unless there is a strong possibility the patient will not take the medication.
5. Patients with syphilis in an environment where they can have direct observed therapy (for example, a hospital or correctional facility) should take doxycycline. The exception is if they are pregnant.

Gentamicin shortage and consultation for alternative treatment

An industry wide shortage of gentamicin was recently reported by local vendors in Wisconsin. For instance, the current stock at the Milwaukee Health Department Keenan Health Center expires on July 31, 2023. The projected release date for gentamicin is October 2023.

Gentamicin is an alternative gonococcal treatment recommended for patients with known or self-reported allergy to cephalosporins, or in other clinical circumstances that may require treatment with a recommended alternative antibiotic to treatment with ceftriaxone. If gentamicin is not available due to reported shortages, the CDC recommends treatment with a single dose of 2 grams of azithromycin. Culture specimens should be collected from all anatomic sites of patient self-reported sexual activity. Recovered isolates should be tested for antibiotic susceptibility (AST) to ensure the patient’s gonococcal infection is susceptible to the recommended alternative treatment.

Treatment regimens for gonorrhea are outlined in the 2021 STI Treatment Guidelines.

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Resources 

For more information regarding the availability of penicillin and gentamicin, visit the FDA Drug Shortage Website.

For more information about syphilis reporting and surveillance in Wisconsin, visit the DHS STI Program.

Resources for AST can be accessed at the Milwaukee Health Department Laboratory and Center of Excellence Reference laboratory for ARGC after consultation for specimen collection and alternative treatment decisions with the DHS STI Unit SURRG Project epidemiology coordinator at DHSDPHARGC@dhs.wisconsin.gov.