Shortage of the Only Drug Approved to Treat Syphilis in Pregnant Patients

Pregnant person examined by health care provider

Rates of syphilis have been steadily rising in recent years with an alarming spike in the number of cases of congenital syphilis. These infections are passed from to infants during pregnancy or childbirth and can lead to miscarriage, stillbirth, prematurity, low birthweight, or death shortly after birth. Treatment during pregnancy can help both parent and child, but there is a shortage of Bicillin-L-A, the only antibiotic approved for this population.

Syphilis is a bacterial infection that is passed through skin-to-skin contact with infected lesions. If left untreated, syphilis progresses through four stages. While it remains curable with antibiotics, complications that may develop in the later stages cannot be reversed with treatment and may include serious damage to the brain, heart, nervous system. In some cases syphilis can lead to death.

The Impact of a Treatment Shortage

Bicillin L-A, also called penicillin G benzathine, is the preferred treatment for primary and secondary (P&S) syphilis in adults, infants, and children. It is the only approved treatment for syphilis in pregnant patients. Pfizer—currently the only manufacturer of Bicillin L-A—announced a manufacturing delay in June and suggested that it would likely lead to shortages of the drug through 2024.

The National Coalition of STD Directors (NCSD) surveyed more than 100 sexual health clinics in late August. It found that in the three months prior to the survey, 40% of clinics had attempted to order Bicillin L-A only to be told it was not available. In addition, 28% of clinics said they had to get the drug from a nearby clinic or refer the patients elsewhere for treatment.

This is not the first shortage of this important antibiotic in recent years. Shortages that began in 2005 continued for almost five years. Shortages began again in 2017 as cases of congenital syphilis were beginning to surge. Pfizer says the shortage is a result of the increase in demand, but advocacy organizations aren’t satisfied with that explanation. A letter to the White House Drug Shortage Task Force signed by 39 organizations notes:

We are also highly skeptical of the company’s attempts to primarily blame the shortage on increasing demand, which appears to unfairly deflect blame to communities affected by syphilis. However, trends in syphilis rates are clear and demand has been and will continue to increase for the foreseeable future; if Pfizer was truly caught completely off guard, it raises significant questions about the competency of the company to forecast obvious infectious disease trends.

As the advocates point out, syphilis rates in the United States have been rising steadily since 2000 and increased 32% between 2020 and 2021 alone. Rates have increased among both males and females, in all age groups and regions of the United States. Gay and bisexual men made up almost half (46.5%) of all P&S cases among men in 2021.

The rise in congenital syphilis is particularly alarming as it represents both a failure of STI prevention/treatment and a failure to provide adequate prenatal care. In 2021, there were 77.9 cases per 100,000 live births in the United Sates. This represents a 30.5% increase from 2020 and 219.3% increase from 2017. There were 220 congenital syphilis-related stillbirths and infant deaths in 2021.

The advocacy groups are asking the White House Drug Shortage Task Force to make this issue a priority and work with the manufacturer to ensure adequate supply quickly. In the meantime, the CDC is suggesting that clinicians prioritize Bicillin L-A for pregnant people with syphilis and babies with congenital syphilis and use doxycycline for other populations. The agency is also reminding clinicians of the importance of thorough exams as a way to properly stage syphilis infections because patients with earlier stages of the infection need less Bicillin L-A.

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