FDA Reports Shortage of Version of Penicillin Used as Standard Syphilis Treatment

FDA Reports Shortage of Version of Penicillin Used as Standard Syphilis Treatment
A sign for the Food And Drug Administration is seen outside of the headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)
Mimi Nguyen Ly

The U.S. Food and Drug Administration (FDA) has reported a shortage of the injectable version of penicillin, citing increased demand for the antibiotic.

In a notice on April 26, the agency said there are shortages of Pfizer’s Bicillin L-A in both regular and pediatric versions. It said the shortage may persist until around the last quarter of the year.

Bicillin L-A is Pfizer’s brand name for penicillin G benzathine, which is administered by injection intramuscularly. Pfizer is the sole supplier of penicillin G benzathine in the United States.

Penicillin G benzathine is the standard treatment for syphilis, a sexually transmitted disease (STD) caused by the bacterium Treponema pallidum.
The drug is also used to treat strep throat, although there are also other alternatives to treat the condition. The Centers for Disease Control and Prevention (CDC) has noted there are high numbers of strep throat cases in the country.

Possible Reasons Behind Increase in Demand

The FDA believes the demand increase for this drug is related to increased cases of strep throat and syphilis in the United States.

“The FDA recognizes the potential impact that increased demand of certain products may have on health care providers and patients,” the agency said in an emailed statement to The Epoch Times.

“While the agency does not manufacturer drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug, the public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or increased demand of certain products.”

Pfizer told NBC News that due to a shortage of amoxicillin, a widely-used antibiotic, doctors were prompted to prescribe penicillin instead. The company added that a rise in syphilis cases probably further increased the demand.

CDC Points to Alternative

The CDC said in mid-April that some STD programs “are currently unable to procure enough penicillin G benzathine,” which it called “the first-line recommended treatment for syphilis.”

It added that the manufacturer—Pfizer—“anticipates the issue will be resolved in the next two months.”

An alternative syphilis treatment for non-pregnant people who has a penicillin allergy is oral doxycycline 100mg twice a day for two weeks for early syphilis or for four weeks for late, latent, or syphilis of an unknown duration, the CDC said.

Otherwise, penicillin G benzathine is “the only recommended treatment for pregnant people infected or exposed to syphilis,” and the STD programs should “[p]rioritize the use of Bicillin L-A to treat pregnant people and babies with congenital syphilis.”

The World Health Organization (WHO) said benzathine penicillin G is the only WHO-recommended treatment for pregnant women with syphilis because it is “the only known drug that can cross the placenta barrier and treat the unborn baby in the womb.”

There were 2,855 congenital syphilis cases in 2021, up from 2,157 in 2020. There were at least 220 stillbirths due to syphilis in 2021, up from 149 in 2020—or by 47 percent.
Separately, Bicillin C-R, a combination of penicillin G benzathine and penicillin G procaine—also manufactured by Pfizer—has been reported as being in short supply by the American Society of Health-System Pharmacists.

This form of penicillin, which is also injected intramuscularly, does not cross the placental barrier, and is not as long-acting as penicillin G benzathine alone, and as such, is not recommended to be used to treat syphilis. It can, however, be used to treat other infections, including streptococcal Group A infections.

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