FDA allows imports of syphilis drug alternate during shortage

US regulators gave temporary permission for importation of a form of penicillin used to treat syphilis amid a national shortage of Pfizer Inc.’s version of the drug along with a dramatic increase in cases.

The Food and Drug Administration authorized importation of penicillin G benzathine made by a French company, Laboratoires Delbert, according to the agency website. Pfizer’s Bicillin L-A, the only version of the drug available in the US, has been in short supply since April.

Penicillin G benzathine is the preferred treatment for syphilis and the only medication for the congenital form of the disease, which killed hundreds of babies and fetuses in 2022. After rates skyrocketed to levels not seen since the 1990s, the US stood up a national task force to address the situation, which the Centers for Disease Control and Prevention’s chief medical officer called “heartbreaking.”

While as little as one injection of penicillin G benzathine can cure syphilis, the shortage prompted US health officials to recommend giving some patients doxycyline, another antibiotic therapy that requires of weeks of twice-daily pills. The long treatment regimen raises the risk that patients might not complete it, leaving them sick and potentially infectious to others.

To fix the shortage, Pfizer has added manufacturing shifts and more than halved production time. The company has invited customers who are having trouble getting the drug to contact them directly. The shortage is estimated to last through June, according to the FDA.

Unlike Pfizer’s pre-filled syringe, Laboratoires Delbert’s formulation of the drug is a powder that must be mixed and then injected by a health-care provider.