January 12, 2024
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Key takeaways:
- The FDA approved the importation of an antibiotic that treats syphilis amid a penicillin shortage in the U.S.
- The shortage is partially due to an increase in syphilis diagnoses, including congenital syphilis.
The FDA said this week that it is working with a French pharmaceutical company to temporarily import into the United States an antibiotic that can treat syphilis as a way to address the country’s penicillin shortage.
Last June, Pfizer announced that it was facing a “limited supply and impending stock out” for two of its injectable penicillin products, in part because of a surge in syphilis infections, including an increase in congenital syphilis — 3,761 reported cases in 2022 alone — that the CDC has called a “crisis.”
Data derived from McDonald R, et al. MMWR Morb Mortal Wkly Rep. 2023;doi:10.15585/mmwr.mm7246e1.
The two products are Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin L-A (penicillin G benzathine injectable suspension).
In a letter sent Nov. 21, 2023, and published by the FDA this week, a representative from the French pharmaceutical company Laboratoires Delbert said it was working with the FDA to import 3.5 million units of the drug Extencilline, which is similar to Bicillin but is not approved by the FDA.
“To address the ongoing shortages of Bicillin L-A in the United States, Laboratoires Delbert in conjunction with Provepharm Inc. and Direct Success, Inc. is coordinating with the FDA to temporarily import Extencilline, Powder and diluent for reconstitution for injection,” Thierry Hoffmann, general manager and co-founder of Laboratoires Delbert, wrote in a letter addressed to health care providers.
In a statement, David C. Harvey, MSW, executive director of the National Coalition of STD Directors, applauded the FDA and HHS for “taking this important step to protect pregnant people and babies by ensuring U.S. health care providers have the essential medicine they need to treat and prevent congenital syphilis.”
“The delays in treatment that women have faced because of the shortage has placed them and their families at grave risk during the nation’s syphilis crisis,” Harvey said. “We hope this is the first step toward seeing a resolution to this shortage, and that HHS and FDA will continue to take steps to ensure that communities never experience a syphilis treatment shortage again.”
References:
McDonald R, et al. MMWR Morb Mortal Wkly Rep. 2023;doi:10.15585/mmwr.mm7246e1.
NCSD applauds FDA’s temporary approval to import crucial congenital syphilis drug amid national shortage. https://www.ncsddc.org/ncsd-applauds-fdas-temporary-approval-of-crucial-congenital-syphilis-drug-amid-national-shortage/. Published Jan. 10, 2024. Accessed Jan. 12, 2024.
Temporary importation of Extencilline, (benzathine benzylpenicillin) powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units with foreign, non-U.S. labeling to address supply shortage. https://www.fda.gov/media/175366/download. Published Jan. 10, 2024. Accessed Jan. 11, 2024.
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Sources/Disclosures
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Source:
Temporary importation of Extencilline, (benzathine benzylpenicillin) powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units with foreign, non-U.S. labeling to address supply shortage. https://www.fda.gov/media/175366/download. Published Jan. 10, 2024. Accessed Jan. 11, 2024.
Disclosures:
Hoffman is employed by Laboratoires Delbert.
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