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Bactrim - Septra - Septrin: restrictions on drug's use advised by UK watchdog

This page is from a campaign by award-winning investigative journalist Brian Deer in The Sunday Times of London over risks and side-effects from this antibiotic, marketed under many names, such as Bactrim, Bactrim DS, Septra, Septra DS, Septrin, Sulfatrim, SMZ/TMP, Septran and co-trimoxazole | The investigation | Symptom searcher | Tell Brian & help others

Below is advice from the UK government's Committee on the Safety of Medicines, as published in the influential British National Formulary from the British Medical Association and the Royal Pharmaceutical Society of Great Britain.


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Bactrim (Co-trimoxazole)

Sulfamethoxazole and trimethoprim

The importance of the sulphonamides has decreased as a result of increasing bacterial resistance and their replacement by antibacterials which are generally more active and less toxic.

Sulfamethoxazole (sulphamethoxazole) and trimethoprim are used in combination because of their synergistic activity. However, co-trimoxazole is associated with rare but serious side-effects (e.g. Stevens-Johnson syndrome and blood dyscrasias, notably bone-marrow depression and agranulocytosis) especially in the elderly (see CSM recommendations below).

CSM recommendations. Co-trimoxazole should be limited to the role of drug of choice in Pneumocystis carinii pneumonia; it is also indicated for toxoplasmosis and nocardosis. It should now only be considered for use in acute exacerbations of chronic bronchitis and infections of the urinary tract when there is good bacteriological evidence of sensitivity to co-trimoxazole and good reason to prefer this combination to a single antibacterial; similarly it should only be used in acute otitis media in children when there is good reason to prefer it.

Trimethoprim can be used alone for urinary- and respiratory-tract infections and for prostatitis, shigellosis, and invasive salmonella infections. Trimethoprim has side-effects similar to co-trimoxazole, but they are less severe and occur less frequently.

British National Formulary, published by the British Medical association and the Royal Pharmaceutical Society of Great Britain. March 2003.


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