FDA allows imports of French syphilis drug alternate during US penicillin shortage

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 doxycycline, 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.

The National Coalition of STD Directors applauded the FDA’s action. “We hope this is the first step toward seeing a resolution to this shortage,” David Harvey, executive director of NCSD, said in a statement. Harvey had previously criticized the federal government’s response.

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. “We continue to supply the market above historical rates, and we are reserving product for emergency needs,” a Pfizer spokesperson said.

The shortage is estimated to last through June, according to the FDA.

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