France. Effective 30 September 2005, the French medicines regulatory agency, Agence française de securité sanitaire des produits de Santé (AFSSAPS), has ordered that preparations of the antibiotics bacitracin, fusafungine, gramicidin or tyrothricin, which are locally administered (nasally or by oropharynx route) should be withdrawn from the market due to a lack of therapeutic efficacy. The agency is of the opinion that such a move would also prevent the emergence of strains of antibiotic-resistant bacteria. Two years ago, the agency had ordered the withdrawal of three other antibiotics, framycetin, neomycin and sulfasuccinamide, for similar reasons. These measures are consistent with AFSSAPS' recently completed review of locally administered antibiotics as part of a national and European action programme to promote the proper use of antibiotics.
Letter to prescribers. AFSSAPS, 19 July 2005 (http://recherche.sante.gouv.fr).
Cetuximab - Recommendations for electrolyte monitoring
USA. ImClone Systems Incorporated and Bristol-Myers Squibb have issued a 'Dear Health-care Provider' letter to announce that the US labelling for cetuximab (Erbitux) has been revised with recommendations for electrolyte monitoring and longer observation periods following cetuximab infusion, following an increased incidence of hypomagnesaemia in clinical trials. The Warnings section has been updated to recommend a 1-hour observation period following cetuximab infusion, and longer observation periods in patients who have infusion reactions. The Dosage and Administration section has also been updated to advise that patients who have infusion reactions may require longer observation periods. The Precautions and Adverse Reactions sections have been updated with recommendations for electrolyte monitoring during and after cetuximab therapy. These recommendations follow the observation in clinical trials of an increased incidence of hypomagnesaemia associated with cetuximab, alone or in combination with chemotherapy, compared with best supportive care or chemotherapy alone; about half of the cetuximab recipients experienced hypomagnesaemia and 10.15% experienced severe hypomagnesaemia. The companies advise that the time to onset of electrolyte abnormalities has ranged from days to months after cetuximab initiation, and that the time to resolution is not well known.
'Dear Health-care Provider' letter from Bristol Myers Squibb Company, 13 September 2005 (http://www.fda.gov).