Pfizer has warned of a possible shortage of Bicillin L-A, a long-acting injection of the antibiotic penicillin used for treating syphilis during pregnancy, after a 10 July recall when batches of the drug were found to be contaminated with floating particles.
The news is the latest twist in a drug shortage that began in 2023, reports CNN.
Pfizer, which said it has received no reports of adverse events related to the recalled shots, has “identified the root cause to be associated with stoppers supplied from an external vendor”, and was implementing “the appropriate corrective and preventative actions”, it said.
Benzathine penicillin G, sold as Bicillin, is used to treat a number of common bacterial infections, like strep throat, in adults and children.
Because one shot can last up to two weeks, it’s especially helpful for people who can’t swallow pills or may not be able to remember to take them. In most cases, however, when it’s not available, doctors can turn to alternatives like the antibiotic doxycycline.
But benzathine penicillin G is the only product that’s approved and recommended to treat syphilis during pregnancy.
If the infection is caught early, a single injection can keep the infection from spreading to a newborn, preventing congenital syphilis.
Without treatment, syphilis during pregnancy can cause miscarriages and stillbirths – and also be fatal for infants. It can also cause vision and hearing problems in babies as well as deformities of the bones and teeth.
Over the past decade, rates of congenital syphilis have increased tenfold in the United States, from 335 in 2012 to more than 3 800 in 2023, according the US Centres for Disease Control and Prevention.
“We’re in a congenital syphilis crisis, and have been calling for an emergency declaration for this for years,” said Dr Jeffrey Klausner, a Professor of Clinical Population and Public Health Sciences at the University of Southern California’s Keck School of Medicine. “This shortage threatens to make that even worse.”
Because too many pregnant patients infected with syphilis weren’t making it into basic primary care, there’s been a push in certain US states to test all pregnant women for syphilis at multiple stages of pregnancy and whenever they arrive in emergency rooms or urgent care clinics.
After an initial positive test, providers are encouraged to treat a pregnant patient with a shot of long-acting penicillin at the same visit, without waiting for the results of a second confirmatory test.
This push for one-stop testing and treatment has already had an effect.
“With the latest release of data, we saw a slowing of rates, which was really exciting,” said a CDC official.
Bicillin L-A most recently experienced a shortage in 2023. During that time, the US Food and Drug Administration has allowed imports of two equivalent products, a French drug called Extencilline, and Lentocilin, which is imported from Portugal and sold by the privately-owned Cost Plus Drugs company. These imports continue to be authorised.
Those forms of the medication are trickier to use, said Erin Fox, associate chief pharmacy officer at the University of Utah Health.
“In a health system, it’s very hard to use imported products,” she added. The bar coding on the drugs isn’t recognised by most hospital systems, and there may be differences in how the products are mixed and diluted, which can be confusing, she told CNN.
Pfizer has also been working to boost its supply. The company stopped shipping paediatric doses in 2023 and instead focused on making adult doses to prioritise supply for pregnant patients.
According to the FDA’s drug shortage website, Pfizer expected to have a delivery of paediatric doses available in October.
Now, the company has advised customers that it will give an update on the Bicillin supply no later than mid-August. Until stock has fully recovered, Pfizer said, it will ration available supplies of the shots.
Providers will have to fill out medical request forms, and the company will send supplies on a per-patient basis.
Pfizer is the sole supplier of Bicillin for the US.
The non-profit National Coalition of STD Directors said it was gathering information from members to understand how far-reaching the impact of the recall may be.
One of its committees which met last week said all of the participants were in the process of returning Bicillin doses to Pfizer. One state returned about 800 vials, “so we expect to hear this is widespread”, said Elizabeth Finley, senior director of communications and programmes for the organisation.
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Concern as syphilis cases in babies, women, skyrocket in Canada and US