The number of cases of congenital syphilis may increase in the United States in the near future. There is a nationwide shortage of the only first-line penicillin-based drug recommended for pregnant women with syphilis to prevent transmission of the infection to their baby, News From The States reports.
The number of cases of congenital syphilis in the country has more than tripled in recent years, reaching nearly 4,000 in 2024, the highest number in three decades. The situation worsened after Pfizer recalled some batches of Bicillin LA (benzathine penicillin-G) in July last year due to the discovery of foreign particles. As a result, some medical institutions have completely lost their drug supplies.
The US Food and Drug Administration (FDA) says supplies will not return to normal levels until December 2027. To cover some of the shortfall, the FDA has authorized temporary imports of a similar drug, Lentocilin, from Portugal.
There is only one manufacturing plant for injectable penicillin-G in the United States, which is operated by Pfizer subsidiary King Pharmaceuticals.
“It is clear to us that having one manufacturer and one factory in the US is a problem. We're talking about the US not being able to produce penicillin. This is absurd,” said Elizabeth Finley, acting director of the National Coalition of STD Directors.
Pfizer admits that demand for Bicillin LA exceeds supply. The drug is typically sold in packs of 10 doses, even if the clinic only needs a few, which can cost consumers thousands of dollars. In addition, amid shortages, wholesale suppliers are raising prices three or four times to make a profit.
“Bicillin LA is now virtually unavailable in the market, but some sellers and distributors still have it in stock and are now increasing the price by three or four times for profit. We don't have any additional budget for this,” said Patrick Fonge of the Navajo Nation Health Foundation's Sage Memorial Hospital in Arizona.
Medical care is not available to everyone
Congenital syphilis can have irreversible consequences for the health of infants. Infected mothers have a significantly increased risk of stillbirth or death of the newborn soon after birth. Possible complications in surviving children include bone deformities, hearing and vision loss, and other serious impairments.
Experts worry that shortages could exacerbate already existing health care inequalities. The highest rates of congenital syphilis in recent years have been among indigenous children in the United States, followed by black children.
In South Dakota, for example, nearly 90% of congenital syphilis cases reported between 2020 and 2023 were among Native American children, even though they make up only 11% of the state's population. At the same time, the total number of cases there decreased slightly, from 40 in 2024 to 37 in 2025. Mississippi is seeing a similar downward trend.
As the publication notes, about 90% of cases of congenital syphilis are associated with a lack of timely testing or proper treatment during pregnancy. Black and Indigenous women are more likely to face barriers to prenatal care.
Due to the shortage of medicine, doctors recommend that healthcare institutions reserve existing stocks of Bicillin LA primarily for pregnant women with syphilis. Alternative drugs, such as doxycycline, may be used to treat non-pregnant patients.
