Purpose
This Dear Colleague Letter highlights FDA’s listing of Penicillin G benzathine injectable suspension products (Bicillin L-A®) on their drug shortage webpage.
What you need to know
Update from FDA- September 9, 2024
FDA's website has been updated to reflect "Available" supply of 2.4 million Units/4 milliliter Bicillin L-A® and 1.2 million Units/2 milliliter Bicillin L-A®. Available supply means that Bicillin L-A® should be used for all appropriate patients per CDC's standard guidance. The pediatric presentation, 600000 Units/1 milliliter Bicillin L-A®, remains unavailable.
July 20, 2023
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.
What you can do
CDC strongly encourages the following priority actions during the ongoing shortage:
Take inventory:
- Monitor local supply of Bicillin L-A® and determine the local pattern of use to forecast need.
- 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.
- Choose doxycycline for non-pregnant people to help preserve Bicillin L-A® supplies. See CDC's treatment recommendations for more.
- 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.
- You can find resources for appropriately staging syphilis from the National STD Curriculum (NNPTC) and the New York City Department of Health and Mental Hygiene Bureau of Sexually Transmitted Infections/New York City STD Prevention Training Center.
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.
- Clinicians with questions about syphilis clinical management should contact an Infectious Diseases specialist or the online National Network of STD Clinical Prevention Training Centers (NNPTC) STD Clinical Consultation Network.
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