Penicillin G benzathine is the recommended treatment for syphilis and the only recommended treatment for pregnant women infected or exposed to syphilis. Pfizer, the sole manufacturer of Bicillin L-A® (penicillin G benzathine) in the United States is experiencing a manufacturing delay of this product. CDC is working with FDA’s Drug Shortage Staff and Pfizer to address this situation.
Please check the FDA’s Drug Shortage website for Pfizer’s plans for allocations to distributors. Until normal quantities of Bicillin L-A® (penicillin G benzathine) are available, CDC suggests the following:
- Refrain from the use of penicillin G benzathine for treatment of other infectious diseases (e.g., streptococcal pharyngitis) where other effective antimicrobials are available.
- Adhere to the recommended dosing regimen of 2.4 million units of penicillin G benzathine IM for the treatment of primary, secondary and early latent syphilis (i.e., early syphilis) as outlined in the 2015 STD Treatment Guidelines(http://www.cdc.gov/std/tg2015/syphilis.htm). Additional doses to treat early syphilis do not enhance efficacy, including in patients living with HIV infection.
- Contact your pharmacists/distributors to procure penicillin G benzathine, if you do not have product readily available. If product reaches a critical supply level of three weeks or less, notify the Pfizer Supply Continuity Team at (844) 804-4677 to inquire about an emergency supply. Also, alert your state or local STD Prevention Program of any shortage of Bicillin L-A® (penicillin G benzathine) as they are informing CDC of any shortages.
- Direct questions about syphilis clinical management to an infectious disease specialist or the on-line National Network of STD Clinical Prevention Training Centers (NNPTC) STD Clinical Consultation Network (https://www.stdccn.org ).
More information on recommended syphilis treatment and clinical management can be found in the 2015 STD Treatment Guidelines(http://www.cdc.gov/std/tg2015/syphilis.htm) (http://www.cdc.gov/std/tg2015/syphilis.htm(http://www.cdc.gov/std/tg2015/syphilis.htm)). CDC is not recommending any changes to these treatment recommendations for patients with syphilis.
Additional information on the availability of penicillin G benzathine can be found at http://www.cdc.gov/std/treatment/drugnotices/bicillinshortage.htm(http://www.cdc.gov/std/treatment/drugnotices/bicillinshortage.htm) or on the FDA’s Drug Shortage website
If you have any questions about the penicillin G benazthine shortage, please contact your state or local health department’s STD Prevention Program. Please share this guidance with other healthcare providers and pharmacists.