A new recall of injected penicillin may put gains against syphilis in peril

CNN

7 days ago

Drugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting injection of the antibiotic penicillin, the preferred option for treating syphilis during pregnancy.
The news – the latest twist in a drug shortage that began in 2023 – follows a July 10 recall of certain lots of Bicillin L-A that were found to be contaminated with floating particles. Pfizer says it has not received any reports of adverse events related to the recalled shots.
'We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,' the company said in a statement, adding that it places the utmost emphasis on patient safety. 'We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.'
Benzathine penicillin G, sold as Bicillin, is used to treat a number of common bacterial infections, such as 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, if the shots aren't 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 the sexually transmitted infection syphilis during pregnancy. If the infection is caught early, a single injection can keep the infection from spreading to a newborn, a condition called congenital syphilis.
Without treatment, syphilis during pregnancy can cause miscarriages and stillbirths. It can also be fatal for infants. Syphilis can also cause vision and hearing problems in babies as well as deformities of the bones and teeth.
As rates of syphilis rose in adults, more babies became infected, too. 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 to data from the US Centers for Disease Control and Prevention.
'We're in the midst of a congenital syphilis crisis, and we've been calling for an emergency declaration for congenital syphilis 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 threatens to make that even worse.'
The shot has been a key part of the strategy that some states have been using to quell rising rates of congenital syphilis.
Because too many pregnant patients infected with syphilis weren't making it into basic primary care, there's been a push in states including New Mexico and Minnesota to test all pregnant women for syphilis at multiple stages of pregnancy and whenever they show up 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 familiar with the data who asked not to be named because they weren't authorized to speak to the media. That progress is the result of hard work bringing awareness to controlling syphilis and congenital syphilis, the official said.
Bicillin L-A most recently went into 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 entrepreneur Mark Cuban's Cost Plus Drugs. These imports continue to be authorized.
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 said. The bar coding on the drugs isn't recognized by most hospital systems, and there may be differences in how the products are mixed and diluted, which can be confusing.
Her hospital has been handling the shortage by being judicious about who gets Bicillin shots. It hasn't had to use an imported products yet.
Pfizer has also been working to boost its supply. The company stopped shipping pediatric doses in 2023 and instead focused on making adult doses to prioritize supply for pregnant patients. According to the FDA's drug shortage website, Pfizer expected to have a delivery of pediatric 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.
Sterile injectable products like Bicillin are especially vulnerable to shortages because they have a more complex manufacturing process than pills and tend to be prone to quality control issues. In this case, Pfizer is the sole supplier of Bicillin for the US.
The nonprofit National Coalition of STD Directors said it's gathering information from members to understand how far-reaching the impact of the recall may be.
One of its committees met Monday, and 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 programs for the organization.
'We had a small reprieve for about, maybe a year, in terms of steady supply. And now this is just a complete kick in the teeth and really threatens our ability to prevent and control syphilis,' Klausner said.
The CDC had previously posted recommendations for caring for syphilis patients during the shortage, but that information has since been taken down. Fox, who investigates drug shortages for the Association of Health Systems Pharmacists, said she has asked the agency to repost it but hasn't received a response.
CDC staffers who work on syphilis control were hit hard by recent government layoffs, although about 200 were reinstated in June. Federal funding cuts have also hampered state and local efforts to control sexually transmitted infections.
The FDA updated its drug shortage page with links to Pfizer's recent guidance but has not posted Pfizer's recall announcement.
A spokesperson for the US Department of Health and Human services referred questions about the recall and potential supply problems to Pfizer.
'I am concerned though that now, with a cut in funds to national and local STD programs, that we will start to see a drop in testing for syphilis,' the CDC official said. 'Cuts to Medicaid and Medicare, as well as other programs, will be devastating for syphilis control.'