Shortage of crucial syphilis treatment could worsen epidemic in the US

USA — Infectious disease experts are sounding the alarm over a new shortage of a vital penicillin medication used in the fight against syphilis.

The scarcity of Bicillin L-A, a long-acting injectable antibiotic also known as penicillin G benzathine, has raised concerns among medical professionals who fear that an extended shortage could exacerbate the U.S. epidemic of this sexually transmitted infection.

Pharmaceutical company Pfizer announced the shortage in a letter last month, attributing it to a significant increase in demand due to the rising rate of syphilis infections.

Moreover, Bicillin L-A has recently been used as an alternative to amoxicillin, another antibiotic that has periodically faced scarcity and is commonly prescribed for various infections such as strep throat.

Steven Danehy, a spokesman for Pfizer, explained that it would take approximately a year for the company to increase production by 50 percent at its Rochester, Michigan plant.

This expansion aims to meet the growing demand for Bicillin and ensure an adequate supply.

Syphilis cases have been on the rise in the United States since 2000, reaching 176,713 reported cases in 2021, representing a nearly 75 percent increase since 2017, as reported by the Centers for Disease Control and Prevention (CDC).

Congenital syphilis, transmitted from mother to child, has tripled during this four-year period, resulting in 2,855 cases, including 220 stillbirths or infant deaths.

The rates of congenital syphilis are highest among infants born to Native American, Native Hawaiian, Pacific Islander, and Black mothers.

Bicillin L-A is the recommended treatment for pregnant women infected with syphilis and has proven highly effective in preventing transmission to the fetus when administered early. Congenital syphilis carries a high fatality rate and can lead to preterm birth and severe birth defects.

The current shortage is troubling for medical professionals who worry about the accessibility of life-saving medication for these mothers.

Dr. Anita Henderson, a pediatrician in Hattiesburg, Mississippi, expressed her concerns, particularly considering the significant increase in congenital syphilis rates in the state over the past five years.

Among adult syphilis cases, nearly one-fourth occur in women, just under a third in men who have sex only with men, and approximately one-fifth in men who have sex exclusively with women.

Untreated syphilis can cause sores, a rash, and severe damage to internal organs, the nervous system, eyes, and ears, and can even be fatal.

Pfizer also warned that the supply of a pediatric version of Bicillin, rarely used but important for managing conditions such as rheumatic heart disease and rheumatic fever in children, would soon run out.

The company redirected the production line of this pediatric drug to increase the supply of adult formula.

Alternative antibiotics are available for these conditions, according to Dr. Meg Doherty, director of global H.I.V., hepatitis, and sexually transmitted infections programs at the World Health Organization.

The scarcity of Bicillin L-A is part of a larger drug shortage crisis affecting vital therapeutic medications and necessitating the rationing of treatments like chemotherapy. A recent Senate report highlighted the supply issues as a threat to national security.

Many pharmaceutical companies have been hesitant to invest in the development of antibiotics due to lower profit margins compared to potential blockbuster drugs that could generate billions of dollars in revenue.

In response to these challenges, a bipartisan group in Congress recently reintroduced the Pasteur Act, a proposed legislation with a budget of US$6 billion.

The act proposes a subscription-based model similar to Netflix, providing financial incentives to pharmaceutical companies for research and development efforts.

While the legislation aims to address drug shortages, its primary objective is to combat the global threat posed by drug-resistant pathogens.

To manage the limited supply of Bicillin, the CDC recommends that doctors prioritize pregnant patients and infected or exposed infants.

For other patients, doxycycline is an alternative treatment, typically prescribed for two to four weeks depending on the stage of the disease.

However, experts express concerns that individuals, including partners of pregnant women, may struggle to adhere to the twice-daily pill regimen, potentially compromising the treatment’s effectiveness.

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