In response to the persistent shortage of front-line syphilis treatment, the US Food and Drug Administration (FDA) has collaborated with French drugmaker Laboratoires Delbert to temporarily allow the import of a crucial medication. Laboratoires Delbert, in a letter, announced their cooperation with the FDA to bring in 3.5 million units of Extencilline, a medication not yet approved in the United States. The FDA officially approved this move on Wednesday, as indicated in the latest update on the agency’s website.
Extencilline serves as a viable alternative to Bicillin, a long-acting injectable form of the antibiotic penicillin manufactured by Pfizer. Bicillin has been facing a Syphilis Medication Shortage since the middle of the previous year, impacting its availability as the recommended treatment for syphilis in adults. Notably, it is also the primary treatment for pregnant women, crucial for preventing congenital syphilis, where the infection can be transmitted from mother to newborn.
Escalating Syphilis Cases Triggered the Syphilis Medication Shortage
The shortage of Bicillin became a critical concern in June, with Pfizer citing challenges in ramping up production due to the stringent regulations and complexities associated with antibiotic manufacturing. Public health groups, recognizing the urgency of the matter, called upon the White House in October to address the shortage, especially amid a surge in syphilis cases across the nation. The FDA’s drug shortages database indicates an anticipated resolution to the supply problem in the second quarter of the current year.
Data from the US Centers for Disease Control and Prevention (CDC) reveals a startling increase in syphilis cases from 2017 to 2021, with a 74% rise. Congenital syphilis cases, affecting newborns, witnessed an even more alarming surge of over 203% during the same period. Shockingly, over 3,700 babies were born with syphilis in the US in 2022, marking a staggering increase of more than 1,000% from 2012 and the highest numbers in over three decades.
National Coalition of STD Directors Applauds FDA’s Swift Action
Recognizing the gravity of the situation, the National Coalition of STD Directors, one of the groups advocating action in the October letter to the White House, welcomed the FDA’s collaborative effort with Laboratoires Delbert. Executive Director David Harvey emphasized the serious risks faced by women and their families due to treatment delays caused by the shortage. He expressed hope that this collaboration marks the initial step toward resolving the Syphilis Medication Shortage, urging both the Department of Health and Human Services (HHS) and the FDA to continue taking measures to prevent future syphilis treatment shortages and ensure adequate resources for affected communities.
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