United States of America - The Food and Drug Administration has approved linezolid, (Zyvox®), the first antibacterial drug of the new oxazolidines class to treat infections associated with vancomycin-resistant Enterococcus faecium, including cases with bloodstream infection. Other indications are treatment of hospital-acquired pneumonia, complicated skin and skin structure infections, including cases of methicillin-resistant Staphylococcus aureus, community-acquired pneumonia and uncomplicated skin and skin structure infections.

Vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus infections are a particular problem in hospitalized or immunocompromised individuals. Since 1989 there has been a rapid increase in the incidence of methicillin-resistant Staphylococcus aureus infections. These organisms are often resistant to multiple antibiotics and limited therapeutic options are available to patients.

The most frequently reported side effects attributed to linezolid in clinical studies were headache, nausea, diarrhoea and vomiting. The most important laboratory test change was a decrease in platelet counts. Linezolid may interact with other drugs, including over-the-counter cold remedies containing pseudoephedrine or phenylpropanolamine and cause an increase in blood pressure.

Due to concerns about appropriate use of antibiotics leading to an increase in resistant organisms, prescribers should carefully consider alternatives before initiating treatment with linezolid in an outpatient setting. The manufacturer anticipates that linezolid will be used principally in hospitals or institutional care settings.

Worldwide licensing is intended by the manufacturer, and an application has also been submitted in the United Kingdom (2).

References

1. FDA Talk Paper, T00-17 (2000).

2. Pharmaceutical Journal, 264: 284 (2000).