Pediatric Amoxicillin Shortage Persists as Winter Approaches

With October approaching, it has been nearly one year since the start of the amoxicillin shortage. According to the United States Food and Drug Administration (FDA), the deficiency was first identified on October 28, 2022. The seemingly endless shortage continues to impact pediatric patients as the liquid formulation of the drug remains in short supply.

Considering the coming cold season, more healthcare professionals and public health experts are concerned about what the shortage will mean for individuals who need the drug.

“It is a problem. Respiratory illness season is coming up, and that’s going to be a huge issue,” David Margraf, a pharmaceutical research scientist with the University of Minnesota’s Resilient Drug Supply Project, told CNN.

According to the Mayo Clinic, amoxicillin is a penicillin antibiotic used to treat bacterial infections. In the US, it is sold under the following brand names: Amoxicot, Amoxil, DIsperMox, Moxilin, and Trimox.

Data from StatPearls notes that amoxicillin has multiple FDA-approved indications, including ear, nose, and throat infections, Helicobacter pylori, lower respiratory tract infections, acute bacterial sinusitis, and urinary tract infections. It has also been used off-label to manage Lyme disease, infectious endocarditis, periodontitis, and actinomycosis.

“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,” said Rohan Khazanchi, MD, MPH, a pediatrician and medical resident at Brigham & Women’s Hospital in Boston, in a conversation with CNN.

In a recent report published by the American Academy of Pediatrics, researchers note that high-dose amoxicillin is the first-line preferred treatment for acute otitis media (AOM), which are middle ear infections. In pediatric patient populations, middle ear infections are the most common indication for antibiotics, signifying that this population is majorly affected by the shortage.

The American Society of Health-System Pharmacists (ASHP) notes that while Aurobindo and Sandoz did not provide a reason for the shortage, Hikma and Teva cited an increased demand. As providers and patients navigate the shortage, the organization notes the following formulations are available:

• Amoxicillin oral capsule, Rising Pharmaceuticals, 250 mg, bottle, 100 count, NDC 57237-0030-01
• Amoxicillin oral capsule, Rising Pharmaceuticals, 250 mg, bottle, 500 count, NDC 57237-0030-05
• Amoxicillin oral capsule, Rising Pharmaceuticals, 500 mg, bottle, 100 count, NDC 57237-0031-01
• Amoxicillin oral capsule, Rising Pharmaceuticals, 500 mg, bottle, 500 count, NDC 57237-0031-05
• Amoxicillin oral tablet, Rising Pharmaceuticals, 500 mg, bottle, 100 count, NDC 57237-0028-01
• Amoxicillin oral tablet, Rising Pharmaceuticals, 875 mg, bottle, 20 count, NDC 57237-0029-20
• Amoxicillin capsule, Teva, 250 mg, bottle, 100 count, NDC 00093-3107-01
• Amoxicillin capsule, Teva, 250 mg, bottle, 500 count, NDC 00093-3107-05
• Amoxicillin tablet, Teva, 875 mg, 100 count, NDC 00093-2264-01

In addition, the American Academy of Pediatrics provides other options to manage bacterial infections despite the shortage.