Amoxicillin Shortage: Why is the Most Popular Antibiotic Suddenly in Short Supply?

As California and the rest of the country plunge toward winter, what health experts are calling a “tripledemic” of viral illnesses—COVID, flu and respiratory syncytial virus, or RSV—is filling hospitals, keeping children out of school and forcing their parents to stay home from work. In fact, workplace absences hit a record high in October, COVID hospitalizations in California leaped 150 percent from early November to December, and RSV hospitalizations in November were 10 times more frequent than is typical for that point in the year.

And those three diseases are not the only ones ravaging the country, and state. Other, harder-to-identify “influenza-like” illnesses are also rising. On Thanksgiving of 2021, the quantity of all influenza-like cases in California was recorded by the Centers for Disease Control as “low.” In 2022, those levels are “very high.” The spike is similar in most of the 48 contiguous states.

At the same time, the United States is suffering a shortage of one of the most important prescription medicines on the market, important especially for children: the antibiotic amoxicillin. In 2021, amoxicillin was the most commonly prescribed antibiotic in the U.S., with 46.4 million prescriptions written, according to CDC data.

What’s going on? Why is one of the most popular and effective medications against bacterial infections going AWOL in the middle of a severe rise in respiratory illnesses?

What Is Amoxicillin?

COVID, flu and RSV, as well as most other influenza-like illnesses are caused by viruses, which means that antibiotics cannot treat them. Like all antibiotics, amoxicillin is effective only against bacteria. 

But multiple research studies have shown that contracting viral illness renders a person more vulnerable to bacterial infections. For example, about one of every seven COVID patients contracted a related bacterial infection. Half of all fatalities in the pandemic were the result of bacterial infections, most often afflicting the lungs, that came along with COVID cases, according to a study published by the journal Frontiers in Microbiology.

Almost all patients in the hospital with serious COVID were given antibiotics which, while not affecting the virus that causes the disease itself, could treat or prevent resulting bacterial infections, according to the study.

Amoxicillin was discovered in 1972 by researchers at Beecham Research Laboratories in the United Kingdom, and became available the same year. At the time, pharmaceutical scientists were looking for an antibiotic that could treat a wider spectrum of bacteria than penicillin—the world’s first antibiotic, which was discovered in 1928 and revolutionized medicine. A drug called ampicillin was the first penicillin-derived antibiotic to be effective against a greater number of bacteria. But amoxicillin was even better, killing still more bacteria and doing it quicker.

In addition to its use to treat respiratory bacterial infections, amoxicillin is commonly used to treat such bacteria-caused diseases as ear infections, tonsillitis, and the venereal disease gonorrhea, among many others.

Why is Amoxicillin in Short Supply?

Starting in November, the American Society of Health-System Pharmacists (ASHP)—a health nonprofit that maintains a database of drug shortages—began reporting that three manufacturers of amoxicillin were experiencing shortfalls. Most of the shortages came in the category of oral powder for suspension, that is, a form of amoxicillin that mixes with liquid for easy consumption by children. 

The drug in capsule form and in chewable tablets (another way to get kids to take the drug) were also seeing shortages, according to ASHP. But none of the manufacturers would tell ASHP the reason why they were short of the antibiotic. Those three are British multinational Hikma, Swiss drugmaker Sandoz, and Israeli pharmaceutical giant Teva, the world’s largest producer of generic drugs.

The U.S. Food and Drug Administration keeps its own database of drug shortages and their reported causes. The companies were slightly more forthcoming for the FDA. Teva and Hikma both gave “demand increase for the drug” as the reason. Sandoz listed “other.”

Why can’t drug companies meet the demand for their products? The answer is, essentially, capitalism. Especially with low-priced, generic drugs there simply isn’t enough profit in keeping surplus supply on hand, which would allow companies to compensate for fluctuations in the demand.

According to an FDA report, drugmakers—especially generic drugmakers—simply lack any incentive to make less profitable drugs, which widely produced generics such as amoxicillin tend to be. “Manufacturers of older generic drugs, in particular, face intense price competition, uncertain revenue streams, and high investment requirements, all of which limit potential returns,” the FDA reported.

Generic pharma firms operate on a “just in time” basis, meaning that they make just enough of their product to meet existing demand, and ship it out the door as soon as it rolls off the production line. There just isn’t any profit in making more of a drug that the market demands, and keeping it in storage. 

Whether the amoxicillin shortages are caused entirely by “demand increase” remains uncertain. Other causes could be some sort of disruption to the supply chain of any of a drug's raw ingredients. Drug manufacturers rely on multiple suppliers to provide each individual ingredient required to make a drug. If even one of those ingredients is delayed, or out of stock, the entire drug-manufacturing process grinds to a halt.

How to Prevent Drug Shortages

Michael Ganio, senior director of pharmacy practice and quality for ASHP, told CNN that the amoxicillin shortage is most likely the result of a spike in demand, caused by the wave of respiratory illnesses—despite those illnesses being viral and not bacterial. 

Despite the clear dangers of prescription drug shortages, there are few mechanisms in place to prevent them, according to the FDA report. There hasn’t even been an effort to gather data, by either the government or the drugmakers themselves, on the harmful effects of shortages. Compiling that data would create an awareness of why drug shortages “lead to worsened health outcomes for patients and increased costs for health care providers.”

The FDA also recommends providing “financial incentives” for companies to keep low-cost generic drugs in adequate supply. If the drugmakers were ensured that they would earn “sustainable” returns on their investments even in fluctuating markets, there would be less chance that they would run out of the drugs that patients, including children, need to recover from illnesses or in some cases, to stay alive.