No End in Sight for Amoxicillin Shortage

3 min read

Sept. 22, 2023 – As respiratory virus season approaches, the shortage of amoxicillin that began last fall still hasn’t been resolved. 

Most manufacturers of the drug still haven’t disclosed the cause of the shortage or why it continues, a group of physicians reported in an August research brief published in the journal Pediatrics. The powdered form of amoxicillin is used to make liquid versions of the medicine that are commonly given to children, who often cannot swallow pills.

Researchers found that the likelihood of a child being prescribed amoxicillin declined by 91% after the shortage was declared.

The study compared how children were treated for ear infections before and after the amoxicillin shortage began. There were 3,076 children in the study. All the kids were treated at a single health system, and the average age was 3 years old. The authors noted that they chose to study ear infection because it’s the most common antibiotic-treated pediatric illness, and amoxicillin is a first-line treatment.

“When there are these big surges in respiratory viral illness, in ear infections and all the things that come with the winter months of the last year or two, the demand has really outweighed what our supply chains can produce. And as a result, the shortages are cropping up all over the country and affecting our patients,” researcher Rohan Khazanchi, MD, MPH, a pediatrician and medical resident at Brigham & Women’s Hospital in Boston, told CNN

The start of the flu season is just weeks away. Respiratory viruses aren’t treated with antibiotics. But those viruses frequently cause secondary problems like ear infections, pneumonia, or sinusitis, which do respond to antibiotics according to a tip sheet for parents that was published by the American Academy of Pediatrics last fall when the shortage began. 

The national shortage of amoxicillin was announced by the FDA in late October 2022. The American Academy of Pediatrics recommended that prescribers use alternatives, such as splitting tablets or capsules of amoxicillin, using second-line alternatives, or simply employing “watchful waiting.” The recent study found there was no increase in watchful waiting at the health system involved in the research.

“What worries us is sort of the generalizability of this issue,” Khazanchi said, according to CNN. “It’s not about the amoxicillin; it’s about the fact that we have drug shortages for reasonably essential medications that are generic and should be widely available.”

One manufacturer, a division of Novartis called Sandoz, told CNN that low prices were driving manufacturers out of the market. Another drugmaker called Teva Pharmaceuticals cited an increase in demand as the cause of the shortage, CNN reported.

In a statement, the FDA noted that it “does not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug,” CNN reported. “The public should rest assured the FDA is working closely with numerous manufacturers, agencies, and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or increased demand of certain products.”

The research study authors said that the FDA should consider doing more to manage the situation.

“Drug shortages have an immediate, sweeping effect on prescribing patterns and should be monitored and intervened upon by regulatory agencies, policymakers, and health systems alike,” they wrote. “The FDA should consider increasing oversight of essential medications, requiring disclosure of supply issues, and incentivizing antibiotic production to mitigate their low profitability.”