FDA allows imports of syphilis drug from France amid nationwide shortage

The Food and Drug Administration (FDA) will temporarily allow the importation of a form of penicillin used to treat syphilis amid a nationwide shortage of the drug. 

The agency said it is working with French company Laboratoires Delbert to import benzathine penicillin G, according to a letter posted on its website.  

Benzathine penicillin G is the preferred treatment for syphilis, and the only recommended treatment for pregnant people and infants with possible syphilis. But it’s been in shortage since April.  

Pfizer, which is the only company manufacturing the drug in the U.S., said it would take until at least the second quarter of 2024 to increase production enough to end the shortage. 

The shortage is coinciding with a significant increase in infections, including syphilis among pregnant people and congenital syphilis.  

Cases of newborn syphilis are rising rapidly in the U.S. and are at the highest level in at least 30 years, according to federal data. There were more than 3,700 infants born with syphilis in 2022, a tenfold increase over the past 10 years. 

A single injection of benzathine penicillin G can cure the early stages of syphilis, and the Centers for Disease Control and Prevention recommends three doses at weekly intervals for latent, or “hidden” syphilis, a period when there are no visible signs or symptoms. 

The shortage prompted health officials to recommend giving some patients doxycyline, another antibiotic that is not injectable and requires weeks of twice-daily pills.