FDA's tough line on antibiotics

March 4, 2003

Brussels, 03 Mar 2003

Many strains of bacteria are already resistant to commonly used antibiotics in Europe and around the world. Thanks to the Food and Drug Administration (FDA), all antibiotics produced in the USA must include a statement on the label warning doctors of the problems of overuse.

On 5 February, the FDA announced new labelling regulations designed to help reduce the development of drug-resistant bacterial strains. The regulation aims to reduce the inappropriate prescription of antibiotics to children and adults for common ailments like ear infections and chronic coughs. According to the European Commission publication, 'Antibiotics resistance: a growing threat', about 60% of antibiotics in human medicine are prescribed for upper respiratory infections, even though most are caused by viruses - against which antibiotics are ineffective.

The danger associated with prescribing antibiotics for viral infections, according to the FDA, is that it can hasten the development of bacterial strains which are resistant to that antibiotic. What's more, these antibiotic resistant bacteria may then be passed on to others, making treatment even more complicated.

Some resistance

In the USA alone, according to the Center for Disease Control and Prevention, half of the 100 million prescriptions written annually by office-based physicians are unnecessary because they are prescribed for the common cold and other viral infections. Unnecessary use of antibiotics in hospitals is also reportedly common.

Yet, despite this problem, analysts are sceptical that the FDA's tighter regulations might make matters worse by discouraging pharmaceutical companies from investing in new antibiotics which are badly needed, according to Forbes website.

But the FDA stands firm. "Antibacterial resistance is a serious and growing public health problem in the United States and worldwide," said FDA Commissioner, Mark McClellan. "Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat." For instance, resistance to penicillin - formerly the preferred treatment for Staphylococcus aureus infections - is now commonplace in many countries.

Another major concern is the emergence of new bacterial strains that are resistant to several antibiotics at the same time. "Infections caused by such multi-drug resistant pathogens present a special challenge, resulting in increased clinical complications and the risk of serious disease that previously could have been treated successfully," explains the Commission. This can result in longer hospital stays and significantly higher costs to society.

Contact: research@cec.eu.int

More information:

'Antibiotics resistance: a growing threat' a commission publication

Forbes article, 'Antibiotic Brealkthroughs Fall Short'

FDA press release

DG Research
http://europa.eu.int/comm/dgs/research/i ndex_en.html

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