Syphilis Hope? FDA Allows French Drug Import to Combat US Shortage

From France to America: FDA Okays Syphilis Drug Import to Fill Gap. Syphilis Hope? FDA Allows French Drug Import to Combat US Shortage. 

Food and Drugs, benzathine penicillin G, syphilis treatment, pharmaceutical shortage, Pfizer, Laboratoires Delbert, congenital syphilis, CDC recommendations, healthcare, antibiotic alternatives.

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In response to a widespread shortage of crucial syphilis treatment, the Food and Drug Administration (FDA) is granting temporary permission for the importation of benzathine penicillin G, a form of penicillin used in treating syphilis.

The FDA is collaborating with French pharmaceutical company Laboratoires Delbert to address the scarcity of benzathine penicillin G, as revealed in a letter published on its website. This specific penicillin is the preferred treatment for syphilis, particularly for pregnant individuals and infants at risk of syphilis. Unfortunately, the drug has been in short supply since April.

Pfizer, the sole manufacturer of benzathine penicillin G in the U.S., has indicated that it will take until at least the second quarter of 2024 to ramp up production sufficiently to alleviate the shortage.

The current scarcity coincides with a notable surge in infections, including cases of syphilis among pregnant individuals and instances of congenital syphilis. Federal data indicates a sharp increase in cases of newborn syphilis in the United States, reaching the highest levels in at least three decades. In 2022 alone, more than 3,700 infants were born with syphilis, marking a tenfold increase over the past decade.

Benzathine penicillin G is a potent remedy for the early stages of syphilis, and it is recommended by the Centers for Disease Control and Prevention (CDC). The CDC advises a regimen of three doses at weekly intervals for latent, or “hidden,” syphilis, a stage characterized by the absence of visible signs or symptoms.

Given the shortage, health officials have suggested an alternative approach for some patients, involving the use of doxycycline, another antibiotic. Unlike benzathine penicillin G, doxycycline is not injectable and requires a weeks-long course of twice-daily pills.