Study: Combination antibiotics may fuel inappropriate use globally

By Brian P, Dunleavy
A new analysis reveals a high use of non-FDA-approved antibiotic combination products globally. File Photo by John Angelillo/UPI
A new analysis reveals a high use of non-FDA-approved antibiotic combination products globally. File Photo by John Angelillo/UPI | License Photo

Jan. 20 (UPI) -- The use of fixed-dose combination antibiotics needs to be reconsidered, given questions about their efficacy and safety, as well as their possible role in increasing antibiotic resistance, according to the authors of a study published Wednesday by PLOS One.

Fixed-dose drug combinations are defined as "a combination of two or more active [drugs] in a fixed ratio of doses [that] may be administered as single-entity products given concurrently or as a finished pharmaceutical product," according to the World Health Organization.


The drugs are used to treat diseases such as tuberculosis, malaria and HIV, but inappropriate use has been reported in some countries, according to researchers.

"A high consumption of fixed-dose combination antibiotics globally was observed, particularly in middle-income countries," researchers from Queen's University Belfast in Northern Ireland wrote.

"Some of these [combinations] may not be clinically appropriate, [and] ... considering the reported concerns in terms of efficacy, toxicity and [resistance], the rationale for using antibiotic fixed-dose combinations should be explored further," they said.

For this analysis, the Queen's University Belfast researchers analyzed antibiotic sales for 2015 in 75 countries, including the United States, where nearly 3 million people are infected with antibiotic-resistant bacteria or fungi each year and 35,000 die as a result, according to U.S. Centers for Disease Control and Prevention estimates.


Of all antibiotics sold, 119 different antibiotic fixed-dose combinations accounted for 23%, the data showed. Nine of the 119 combinations have been approved for use by the U.S. Food and Drug Administration.

Eighty percent of fixed-dose combination antibiotics are not included on the WHO's Essential Medicines List, which lists medications the agency considers to be most effective and safe to meet the most important health needs.

The highest number of antibiotic fixed-dose combinations sold were in the penicillin family, an older-line category of drugs subject to significant resistance, the researchers said.

The countries with the highest number of antibiotic fixed-dose combinations sold were India, with 80; China, with 25; and Vietnam, with 19, the data showed.

Antibiotic resistance occurs when germs, including bacteria and fungi, are no longer killed by these drugs, and it is fueled by overuse of them. Resistant bacteria and fungi can spread globally, according to the WHO.

For this reason, the agency describes antibiotic resistance as one of the "biggest threats to global health."

"International initiatives may be needed to regulate the manufacturing and sale of these medications while maintaining access to essential antibiotics," the researchers wrote.

"Central guidance from the WHO Essential Medicines List could be helpful to assist in determining the clearly inappropriate fixed-dose combinations and discouraging their manufacture and sale," they said.


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