Congenital Syphilis Skyrockets as US Has Shortage of Drug That Treats It

The U.S. is experiencing a critical shortage of Bicillin L-A, the only first-line medication recommended for pregnant women with syphilis to prevent transmission to their babies. Pfizer’s subsidiary, King Pharmaceuticals, voluntarily recalled the drug in July 2023 due to contamination in batches, with the FDA projecting normal supplies won’t return until December 2027. The shortage is exacerbated by a single manufacturing plant in Michigan, leaving no generic alternative available. Congenital syphilis cases have tripled in recent years, reaching nearly 4,000 in 2024—the highest annual total in three decades. A federal report attributed 90% of cases to delayed testing or treatment, with Black and Indigenous women and babies disproportionately affected. In South Dakota, nearly 90% of congenital syphilis cases from 2020–2023 involved Native American infants, despite Indigenous people making up only 11% of the state’s population. State health departments are prioritizing Bicillin L-A for pregnant syphilis patients and their infants, though some clinics have lost entire stockpiles. The FDA has temporarily approved imports of Lentocilin, a Portuguese alternative, but experts warn this is not a long-term solution. Penicillin’s complex manufacturing process and past shortages have compounded the crisis, with Elizabeth Finley of the National Coalition of STD Directors calling last year’s recall the most severe yet. Congenital syphilis can cause stillbirths, newborn deaths, or severe complications like bone deformities, deafness, or blindness. Dr. Kelly Johnson, an infectious disease physician at UCSF, emphasized that no level of fetal exposure to syphilis is safe, making timely treatment critical. California alone saw congenital syphilis cases rise almost fivefold over the past decade, returning nearly 20% of its Bicillin stock due to the recall. Health disparities worsen the crisis, as Black and Indigenous women often lack access to prenatal care, where syphilis testing and treatment could prevent transmission. Finley noted that the shortage disrupts treatment plans, leaving providers scrambling to secure medication for high-risk patients before delivery. Without intervention, experts fear infection rates and disparities will continue to worsen.