The antibiotic can no longer be used in moderate acne vulgaris, eradication of Helicobacter pylori, and prevention of exacerbations of asthma.
The EMA’s Committee for Medicinal Products for Human Use has recommended several changes to the way the antibioticThe recommendations aim to optimize the use of the antibiotic and minimize the development of antimicrobial resistance , CHMP said.
CHMP’s review and re-evaluation of the benefits and risks of azithromycin medicines given by mouth or IV infusion came at the request of the German Federal Institute for Drugs and Medical Devices. It has led to new changes that include uses of the drug to be refined and harmonized, uses to be discontinued, and a new product warning., mainly concern upper and lower respiratory tract infections, sexually transmitted diseases, female reproductive system infections, dental infections, and treatment and prevention of types of. This is because its effectiveness in these conditions has not been clearly demonstrated, including that its benefits do not outweigh its risks. These indications will be removed from the product information. The committee pointed out that some azithromycin medicines are also approved in the EU for topical use, but that these medicines are out of the scope of the review procedure.but is also classified by the WHO as an antibiotic that carries a higher risk for antimicrobial resistance. It is included in WHO’s Watch category infound that the prevalence of azithromycin resistance in pathogenic bacteria from clinical samples was 22%, and indicated an increase in prevalence after the COVID-19 pandemic, which the study’s researchers described as “a major concern.” CHMP explained that a new warning will also be included in the summary of product characteristics about the importance of clinicians assessing the benefits and the risks, considering the local prevalence of resistance, and deciding when preferred treatment regimens are not indicated. This is based on the fact that azithromycin could favor the development of resistance due to its long-lasting, decreasing levels in plasma and tissues after the end of treatment. Rob Hicks is a retired National Health Service doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online publications. He is based in the United Kingdom.All material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
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