Amid rising syphilis infections in the United States and a continuing shortage of Pfizer’s penicillin G injectable Bicillin, the Food and Drug Administration (FDA) is allowing the temporary import of a similar but US-unapproved drug from a French pharmaceutical firm.
In a letter to Paris-based Laboratoires Delbert on the FDA website, the agency approved the import into the US market of prescription penicillin G benzathine (brand name, Extencilline) powder and diluent for reconstitution for injection. The drug is made in Italy and is being imported by Provepharm for distribution by Direct Success.
Key differences between 2 drugs
The FDA letter warns of important differences between Bicillin and Extencilline, such as that the latter lacks some US-required labeling and instructions and contains soy, which may cause allergic reactions in people with a sensitivity. Also, Bicillin comes in filled syringes, while Extencilline requires reconstitution.
The FDA first announced the Bicillin shortage on its website in late April 2023. In June, Pfizer warned customers of a coming depletion. In December, the American Society of Health-System Pharmacists (ASHP) said Bicillin was in short supply because Pfizer, the sole US supplier of the formulation, was prioritizing it for rising adult syphilis cases. "Once current supplies of the pediatric Bicillin-LA vials are depleted, it is unclear when more product will be manufactured," ASHP said on its website.
Since bottoming out in 2000 and 2001, syphilis rates have climbed nearly every year, spiking 28.6% in 2020 and 2021, according to the most recent data from the US Centers for Disease Control and Prevention.
Once current supplies of the pediatric Bicillin-LA vials are depleted, it is unclear when more product will be manufactured.
Rates of the sexually transmitted infection have also been spiking in newborns, with 10 times as many babies born with it in 2022 than the annual rate 10 years prior, raising rates to their highest in 30 years or more, the American Academy of Pediatrics noted on its website. Other antibiotics can be used in adults and children, but they don't offer the convenience of Bicillin, which is the only one approved for treatment of infected pregnant women.