§ Mr. TrendTo ask the Secretary of State for Health if the Medicines Control Agency has now considered the place of co-trimoxazole in current clinical practice. [33470]
§ Mr. SackvilleThe Medicines Control Agency has considered this matter and consulted the Committee on Safety of Medicines. The Government propose fully to implement their advice, which is that the indications for co-trimoxazole should be restricted to the following:
- Treatment and prophylaxis (primary and secondary) of Pneumocystis carini pneumonitis in adults and children.
- Treatment and prophylaxis of toxoplasmosis, treatment of nocardia.
- Treatment of acute exacerbations of chronic bronchitis and urinary tract infections, where there is bacterial evidence of sensitivity to co-trimoxazole and good reason to prefer this combination to a single antibiotic.
- Treatment of acute otitis media in children, where there is good reason to prefer co-trimoxazole to a single antibiotic.
The CSM also advised that there are no new safety issues with co-trimoxazole but proposed clarification of the safety information in data sheets and that patient information leaflets should be introduced as soon as possible. An article in "Current Problems in Pharmacovigilance" will be published shortly providing these findings to health professionals. A copy of the bulletin will be placed in the Library.