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Antibiotic Shortages: A Serious Safety Concern

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 12, 2023.

Antibiotic Shortages in the US

Shortages of antibiotics in the U.S. has dominated the headlines in recent years, especially during the pandemic. In fact, according to experts, antibiotics are being removed from the market six times faster than new ones are being produced.

This is of great concern to the FDA and the healthcare community as many of these antibiotics were the sole drugs to treat certain antibiotic-resistant infections or for certain infectious conditions in children. Many life-threatening infections can be picked up from being in the hospital (nosocomial infection), outpatient surgery or doctor’s office.

In a study done at George Washington University, nearly half the shortages were for antibiotics needed to treat severe infections, including Clostridium difficile, carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa, among others.

Even common antibiotics used to treat serious infections in patients allergic to penicillin or sulfa drugs have been in short supply with no alternate manufacturers.

What causes drug shortages?

Manufacturing site problems, lack of raw materials, low commercial incentive, and lack of approved manufacturers can all lead to drug shortages. Researchers contend that shortages will continue and that the U.S. government and FDA need to be involved to ensure adequate supplies of life-saving antibiotics.

FDA officials are working closely with industry, health care providers and patients to take action against drug shortages. Although manufacturers are not required to notify the FDA of drug shortages, when they do, the FDA can work with other firms to determine if the drug can be made.

The FDA has the ability to expedite inspections and approvals to help lessen the impact of a drug shortage, including antibiotics.

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Further information

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