FDA Working to Import Syphilis Medication in Light of Shortages

Jan. 12, 2024
The drug contains the same antibiotic as the leading syphilis medication in the U.S., which helps cure syphilis in adults and prevent congenital syphilis

The US Food and Drug Administration (FDA) is in the process of importing a syphilis medication amid ongoing shortages of the treatment.

According to a CNN news article, Extencilline, the medication, which is not approved in the U.S., is “similar to Bicillin, a long-acting injectable form of the antibiotic penicillin made by Pfizer that has been in short supply since the middle of last year. It’s the recommended treatment for syphilis in adults and one of a range of options to use against the infection in children.”

The antibiotic – specifically penicillin G benthazine -- is the only medication for the congenital form of the disease, according to a Fortune article about the FDA’s attempts to import the drug. From 2017 to 2021, reported cases of syphilis in the U.S. were up 74%, and cases of congenital syphilis increased at more than a whopping 203% rate, according to the U.S. Centers for Disease Control and Prevention. Since 2012, over 3,700 babies, a “rise of more than 1,000%” from 2012, were born with syphilis. Syphilis in infants can be “severe, disabling and even life-threatening” despite the fact that it is nearly always a preventable outcome. “A single course of penicillin at least a month before delivery” will almost always prevent infected mothers from passing the disease to their newborns.

In the absence of Bicillin, according to a Fortune article, US health officials were forced to prompt US health officials to treat patients with syphilis with doxycycline. While still an effective treatment, the regimen is much longer with doxycycline, raising “the risk that patients might not complete it, leaving them sick and potentially infectious to others.” Meanwhile, Bicillin and Extencilline, which are the same antibiotic, can cure syphilis with “as little as one injection.”

The shortage is estimated by the FDA to last until June of 2024. This temporary importation of around 3.5 million units of Extencilline should provide relief to the shortage, which has been ongoing since the middle of 2023.

CNN’s website has the article.