The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have announced and listed long-acting penicillin G benzathine injectable suspension products (Bicillin® L-A) on their respective drug shortage webpages, estimating a recovery timeframe in Q4 2023. This is of considerable concern to California as the state continues to see significant increases in syphilis, including syphilis in pregnant persons and congenital syphilis in infants.
Benzathine penicillin G is the recommended, first-line treatment for syphilis, and the only recommended treatment for pregnant people. Prompt and timely treatment of syphilis in pregnancy is nearly 100% effective at preventing devastating outcomes of congenital syphilis, including the fact that up to 40% of infants born to pregnant people with untreated syphilis will be stillborn or suffer early infant death, or face long-term morbidity including blindness, deafness, and bone damage.
Among non-pregnant adults:
Doxycycline 100 mg PO BID x 14 days is an acceptable alternative for those with primary, secondary, or early latent syphilis.
Doxycycline 100 mg PO BID x 28 days is an acceptable alternative for those with late latent syphilis or syphilis of unknown duration.
Use of other intramuscular formulations of penicillin, including Bicillin® C-R, are not acceptable alternatives for the treatment of syphilis.
Given the current Bicillin® L-A drug shortage, the California Department of Public Health (CDPH) STD Control Branch (STDCB) recommends the following:
Prioritize Bicillin® L-A for pregnant people with syphilis infection (or exposure) as well as for infants exposed to syphilis in utero.
Prioritize Bicillin® L-A for patients with contraindications to doxycycline (e.g., anaphylaxis, hemolytic anemia, Stevens Johnson syndrome).
Conserve Bicillin® L-A by using alternative drugs for the treatment of infectious diseases (e.g., streptococcal pharyngitis) where oral medications or other effective antimicrobials are available.
Contact your local health department if you are experiencing a Bicillin® L-A shortage and/or having trouble obtaining the medication.
Follow-up clinical and serologic evaluation should be performed after treatment at the recommended intervals per the 2021 CDC STI Treatment Guidelines.
Health care providers can monitor the Bicillin® L-A drug shortages on the FDA Drug Shortages webpage. For clinical questions related to the treatment of syphilis during the Bicillin® L-A shortage, please contact the STD Clinical Consultation Network, your local health department, or CDPH STDCB at (510) 620-3400 by phone or email@example.com by email.
Original Signed by Dr. Kathleen Jacobson
Kathleen Jacobson, MD
Chief, STD Control Branch
California Department of Public Health