Shortages of Antimicrobial Agents
April 1, 2025
By Stan Deresinski, MD, FIDSA
Synopsis: Shortages of antimicrobial drugs are frequent and represent a danger to patients and to public health.
Source: Bartoo AS, Gilmer MA, Tichy EM. Antimicrobial shortages: A global issue impacting infectious diseases. Clin Infect Dis. 2025;80(2):249-252.
On June 12, 2023, an updated notice was posted indicating an ongoing shortage of Bicillin L-A (injectable benzathine penicillin G) as well as Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension in prefilled syringes).1 It included an estimated “recovery” of just a few months, but, in fact, recovery still has not occurred. On Feb. 24, 2025, it was indicated the sole supplier of Bicillin-LA estimated a resupply date of June 2025.2 While the medication’s unavailability complicates the management of other infections, it leaves clinicians and public health workers with no known effective treatment of congenital syphilis or syphilis during pregnancy.3 As a temporary partial stopgap measure, the Food and Drug Administration (FDA) has allowed the importation of Extencilline (benzathine benzylpenicillin) in quantities of 1,200,000 units and 2,400,000 units. This non-FDA-approved product is manufactured in Italy and marketed in France. Importation of Lentocilin from Portugal also is allowed temporarily.
Bartoo and colleagues have addressed the general question of the impact of antimicrobial shortages on the management of infectious diseases, which has become a global issue. They point out that 37 antimicrobials were in short supply in the United States as of May 31, 2024. Among the key global shortages they discuss are those of anti-tuberculosis medication, which may result in the use of less effective regimens and greater adverse effects. There have been intermittent shortages of injectable acyclovir as well as of the oral form. They also discuss vaccine and monoclonal antibody shortages.
The reasons for these critical shortages are manifold. For economic reasons, drug manufacturing has moved overseas, and large portions of it occur in just a limited number of countries. In some, quality concerns remain, and adequate FDA oversight of overseas manufacturing often is problematic. Price competition often is fierce, further lowering the profit margins for the sale of generics. Even geopolitical events may cause problems; Brexit was associated with significant drug shortages as the movement of products between England and countries of the European Union became difficult.
Natural disasters, such as tornados and hurricanes, have destroyed drug manufacturing facilities. The (often misguided) increase in prescriptions led to a shortage of amoxicillin during the COVID-19 pandemic.
Commentary
All infectious disease clinicians in the United States have had to deal with shortages of individual antimicrobials. This overview describes the reasons, which are multiple and, of course, include profit motive. The authors discuss a number of remedies, albeit only in general terms. Many can be considered policy approaches, such as the creation of critical stockpiles to deal with anticipated shortages, acting as a buffer. Among the necessary responses include investment in manufacturing and distribution while dealing with the issue of profit motive, which drives this and all other industries. As has long been discussed regarding the issue of antimicrobial availability, this will involve the creation and implementation of effective incentives.
Stan Deresinski, MD, FACP, FIDSA, is Clinical Professor of Medicine, Stanford University.
References
1. Availability Update for Bicillin® L-A (penicillin G benzathine injectable suspension) and Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) Prefilled Syringes. June 12, 2023. https://www.fda.gov/media/169427/download
2. American Society of Health-System Pharmacists. Current drug shortages. Feb. 24, 2025. Penicillin G benzathine. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=909&loginreturnUrl=SSOCheckOnly
3. Batteiger T, Liu E, Sheffield J, et al. ASTDA Position Paper: Alternatives to benzathine penicillin G for the treatment of syphilis during pregnancy. Sex Transm Dis. 2025;52(4):195-200.
Shortages of antimicrobial drugs are frequent and represent a danger to patients and to public health.
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