Clinical Reminders during Bicillin L-A® Shortage

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July 20, 2023

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Dear Colleagues,

We would like to bring your attention to FDA’s listing of Penicillin G benzathine injectable suspension products (Bicillin L-A®) on their drug shortage webpage, noting limited supply due to increased demand. In addition, Penicillin G procaine has been discontinued by the manufacturer.

We are aware that jurisdictions may currently be experiencing challenges procuring enough Bicillin L-A® to meet their needs. As we await resolution of this issue, it remains critical that limited inventory be used to treat the patients who need it most.

CDC strongly encourages the following priority actions during the ongoing shortage:

Take inventory:

  • Continue to contact distributors to procure Bicillin L-A® as appropriate. Contact Pfizer (see “Dear Patient Letter” posted on the FDA website) if there is less than a 2-week supply, the distributor has no supply, and there is a risk that patients may not be treated.

Prioritize using Bicillin L-A® to treat pregnant people with syphilis and babies with congenital syphilis – penicillin is the only recommended treatment for these populations.

  • Consider involving antimicrobial stewardship leaders to help institute systems-level approaches to limit the use of Bicillin L-A® and encourage the use of alternative effective antimicrobials for treatment of other infectious diseases.

Appropriately stage syphilis cases to ensure appropriate use of antimicrobials. Early syphilis (primary, secondary and early latent) only requires 2.4 million units of Bicillin L-A®.

See the CDC STI Treatment Guidelines. A few reminders:

  • A thorough physical exam is necessary to accurately stage syphilis. Primary lesions are often hidden inside the mouth, anus or vagina; signs of secondary syphilis may be found on the skin, mouth or anogenital area (i.e. mucus patches, condyloma lata). The rash of secondary syphilis can be subtle.
  • Historical syphilis serologic test results can assist with staging a patient with latent syphilis as early latent, if there is evidence of new infection within the last year (i.e. new seroconversion or a sustained four-fold increase in RPR titer in an individual who has had syphilis in the past).
  • Reviewing signs and symptoms and sexual partner history from the past 12 months can assist with determining the likelihood of syphilis acquisition within the last 12 months, which also only requires 2.4 million units of Bicillin L-A ® instead of 7.2 million units.

Communicate with healthcare providers and pharmacists.

  • Notify healthcare providers and pharmacists of the limited availability of Bicillin L-A® so they are aware and can plan.

Notify DSTDP of any shortage of Bicillin L-A® so we can continue to monitor this situation and provide situational awareness to FDA and Pfizer.

  • If you are an STD-PCHD recipient and have questions about any of this information or need assistance, please contact your project officer.
  • For other groups who are encountering challenges securing this drug to treat pregnant patients with syphilis, please contact stdshortages@cdc.gov.

We appreciate all your hard work to prevent and address syphilis.

Sincerely,

Laura Hinkle Bachmann, MD, MPH, FIDSA, FACP
Chief Medical Officer
Division of STD Prevention
National Center for HIV, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention

Leandro Mena, MD, MPH, FIDSA
Director
Division of STD Prevention
National Center for HIV, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention