France. Agence française de securité sanitaire des produits de Santé (AFSSAPS), the French Medicines Agency, has recommended new measures to prevent and treat any activation of latent tuberculosis that might develop during a course of treatment with anti-tumour necrosis factor (anti-TNF) alpha products. The updated advice includes etanercept (Wyeth's Enbrel) and adalimumab (Abbott's Humira), both of which are marketed in France. According to the advice, patients should undergo a skinreaction test for tuberculosis (TB) before a course of anti- TNF alpha products and during treatment as well, should they present with symptoms of TB; patients should be treated for TB if the tuberculin skin-test reaction is larger than 5 mm (as opposed to the previous advice of 10 mm). The agency advises that a larger dose of isoniazid (5 mg/kg/day as opposed to the previously recommended dose of 4 mg/kg/day) should be used to treat these cases of TB. However, 4mg/kg/day is still the recommended dose if isoniazid is used along with rifampicin.
Reference:
AFSSAPS, 26 July 2005 (http://recherche.sante.gouv.fr).