Drugmaker Pfizer warns doctors that there is a low supply of vicillin LA, a long-acting injection of the antibiotic penicillin, a preferred option to treat syphilis during pregnancy.
The news, the latest twist on drug shortages that began in 2023, follows the recall of certain lots of Vicillin LA, which have been found to be contaminated with suspended particles. Pfizer says he has not received any reports of adverse events related to the recalled shot.
“We are identifying the root cause associated with stoppers supplied by external vendors and implementing appropriate corrections and precautions,” the company said in a statement, adding that it has the highest priority on patient safety. “We are fully aware of the importance of this drug for our patients and are working as quickly as possible to resolve the problem.”
Benzathine Penicillin G, sold as vicillin, is used to treat many common bacterial infections such as the streptococcal throat in adults and children. One shot can last up to two weeks, making it especially useful for those who are unable to swallow pills or don’t remember to take them. However, in most cases, if shots are not available, doctors can resort to alternatives like the antibiotic doxycycline.
However, benzathine penicillin G is the only product that has been approved and recommended to treat sexually transmitted syphilis during pregnancy. If an infectious disease is arrested early, a single injection can prevent the infection from spreading to a newborn, a condition known as congenital syphilis.
Without treatment, syphilis during pregnancy can lead to miscarriage and stillbirth. It can be fatal for babies too. Syphilis can cause not only bone and teeth deformities, but also vision and hearing problems in babies.
As the rate of syphilis in adults increased, more babies were infected too. Over the past decade, the rate of congenital syphilis has increased from 335 in 2012 to over 3,800 in 2023, according to data from the Centers for Disease Control and Prevention.
“We are in the midst of the crisis of congenital syphilis and have been calling for an emergency declaration of congenital syphilis for many years,” said Dr. Jeffrey Krausner, professor of clinical population and public health sciences at the University of Southern California, Keck University School of Medicine. “This threatens to make it even worse.”
This shot was an important part of the strategy several states are using to suppress the rate of congenital syphilis rise.
With so many pregnant women infected with syphilis, it is being promoted in states, including New Mexico and Minnesota, testing all pregnant women with syphilis at multiple stages of pregnancy and whenever they appear in emergency rooms or emergency clinics.
After the first positive test, the provider recommends treating pregnant patients at the same visit at the same visit without waiting for the results of the second confirmation test.
This push for one-stop testing and treatment has already been effective.
“We found out that the latest release of data has slowed the rates, but this was really exciting,” said a data-savvy CDC official who was asked not to name because they were not allowed to speak to the media. The advancements are the result of efforts to bring awareness to control syphilis and congenital syphilis, officials said.
Bicillin LA has recently been short of its own in 2023. Meanwhile, the US Food and Drug Administration is permitting imports of two comparable products, a French drug called Extencilline and Lentocilin, imported from Portugal and sold by entrepreneur Mark Cuban’s Cost Plus Drugs. These imports continue to be approved.
Erin Fox, assistant chief pharmacy director at the University of Utah Health, said these forms of drugs are difficult to use.
“In a health system, imported products are extremely difficult,” she said. Coding of drug bars is not recognized by most hospital systems and can be confusing because there may be differences in the way products are mixed and diluted.
Her hospital has dealt with shortages by being wise about who gets a shot of Vicillin. You don’t need to use imported products yet.
Pfizer has it We are also working to increase its supply. The company stopped shipping pediatric doses in 2023 and instead focused on creating adult doses to prioritize supply of pregnant patients. According to the FDA’s drug shortage website, Pfizer expected to deliver pediatric doses in October.
The company is currently advising customers to provide up-to-date information on vicillin supply by mid-August. Pfizer said it will distribute available supply of shots until the stock recovers fully. Providers must complete a medical request form and the company will send supplies to each patient.
Sterile injectable products such as vicillin are particularly vulnerable to shortages, as they have more complex manufacturing processes than pills and tend to cause quality control issues. In this case, Pfizer is the only supplier of Vicillin in the US.
Nonprofit Associations of STD Directors He said he is gathering information from members to understand how far the recall is impacted.
One of the committees met on Monday, and all participants were in the process of returning the dose of vicillin to Pfizer. Elizabeth Finley, senior director of organizational communications and programs, said:
“We had a small reprieve for probably a year in terms of stable supply, and now this is a complete kick in the teeth, really threatening our ability to prevent and control syphilis,” Klausner said.
The CDC previously posted recommendations for care of patients with syphilis. It’s missing, but that information has since been deleted. Fox said he investigated the medical system’s Pharmacists Association’s drug shortage and asked the agency to repost it, but had not received a response.
CDC staff working on syphilis control have been hit hard by recent government layoffs, but about 200 people were revived in June. Federal funding cuts also hamper state and local efforts to control sexually transmitted diseases.
FDA updated its drug shortage page Here is a link to Pfizer’s recent guidance However, they have not posted an announcement of Pfizer’s recall.
A U.S. Department of Health and Human Services spokesperson referred to Pfizer with questions about recalls and potential supply issues.
“I’m now beginning to see a decline in syphilis testing with cuts in funding for both national and local STD programs,” a CDC official said. “Medicaid and Medicare reductions, and other programs, are devastating for syphilis control.”
