Health Advisory

Summary

• Bicillin L-A is the only CDC-recommended syphilis treatment for some patients, including pregnant people infected with or exposed to syphilis and infants with congenital syphilis.
• The FDA listed a shortage of penicillin G benzathine injectable suspension products (Bicillin L-A®) on April 26, 2023. Pfizer provided an availability update (https://www.fda.gov/media/169427/download) on June 12, 2023, with an expected recovery in the second quarter of 2024. There are no emergency stockpiles of this medication, and product is being allocated with limited inventory released, resulting in the supply not meeting demand.

Suggested Actions

• MONITOR your practice’s supply of penicillin G benzathine. Providers should work with their supplier or Pfizer directly regarding product availability.
• PRIORITIZE treatment of syphilis and patients with no other recommended options with Bicillin L-A.
  • Although Bicillin L-A remains the treatment of choice for patients with syphilis, CDC has recommended that healthcare providers prioritize the use of Bicillin L-A to treat pregnant people and infants with congenital syphilis (https://www.cdc.gov/std/treatment/drug-notices.htm).
  • If a drug shortage of Bicillin L-A warrants alternative therapy, consider using doxycycline to treat syphilis for adult patients who are not pregnant or allergic to doxycycline. This will help ensure Bicillin L-A doses are available for the priority populations below:
    • Pregnant people and their sexual partners
    • Neonates and infants with congenital syphilis
    • People of reproductive age who can get pregnant and their sexual partners
    • Patients with doxycycline allergy
    • Patients who have already begun a course of treatment with either 1.2MU or 2.4MU doses of Bicillin L-A.
  • Use alternatives to Bicillin L-A to treat other infectious diseases (such as streptococcal pharyngitis) when other treatment options are available.
• TREAT all cases of syphilis.
  • Bicillin L-A remains the treatment of choice for patients with syphilis.
  • If needed due to drug shortage, below are the CDC-recommended courses of treatment using doxycycline for patients diagnosed with probable syphilis.
    • Early syphilis (primary, secondary, or early latent): Doxycycline 100mg by mouth twice daily for 14 days.
    • Late syphilis (late latent or unknown duration): Doxycycline 100mg by mouth twice daily for 28 days.
  • Clinicians with questions about syphilis clinical management may contact the National Network on STD Prevention Training Centers (NNPTC) STD Clinical Consultation Network at https://www.stdccn.org/.
• LINK TO TREATMENT with Bicillin L-A any pregnant people and babies with congenital syphilis.
  • If your practice has no supply of Bicillin L-A, the Fairfax County Health Department is available to help coordinate treatment of persons not recommended for alternative treatments for their syphilis infection.
  • Please call the Division of Epidemiology & Population Health at 703-246-2411 for coordination of treatment or additional questions.

Additional Information

• Virginia has observed an increased incidence of syphilis among adults and congenital syphilis. Reported cases of syphilis during the first four months of 2023 were 22% higher than during the same timeframe in 2022, and six cases of congenital syphilis have been reported so far this year. The number of syphilis cases with ocular, optic or neurological manifestations has increased 118% from 2022 compared to the first four months of 2023. Many syphilis diagnoses are occurring among persons who inject or otherwise use drugs. Successful disease intervention efforts by health counselors in local health departments have also led to increased utilization of Bicillin L-A to treat patients infected with syphilis and their exposed partners.
• To read the full update on the shortage of Penicillin G Benzathine (Bicillin L-A) from the Virginia State Health Commissioner, please visit: https://www.vdh.virginia.gov/clinicians/clinician-letters/.

Resources

• CDC’s STI Treatment Guidelines Provider Resources webpage contains links to wall charts, pocket guides, and other materials relevant to the diagnosis and treatment of syphilis and other STIs- https://www.cdc.gov/std/treatment-guidelines/provider-resources.htm.
• VDH Division of Disease Prevention’s Health Professionals webpage contains links to reports and other resources relevant to the provision of sexual health services and management of STIs- https://www.vdh.virginia.gov/disease-prevention/hcw/.
• FDA Drug Shortages Notice- https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Penicillin%20G%20Benzathine%20Injectable%20Suspension&st=c&tab=tabs-1.