isoniazid regulatory update

EMA issued an assessment report recommending increasing the pediatric dose of first-line tuberculosis (TB) drugs. EMA agreed with 2008 World Health Organization recommendations that the recommended pediatric doses of TB drugs given alone should be as follows: 10 mg/kg isoniazid, with a range of 10-15 mg/kg; 15 mg/kg rifampicin, with a range of 10-20 mg/kg; 35 mg/kg pyrazinamide, with a range of 30-40 mg/kg; and 20 mg/kg ethambutol, with a range of 15-25 mg/kg. Last year, EMA's CHMP began a review of pediatric dosing recommendations of TB drugs after published pharmacokinetic data on the medicines showed current treatment recommendations are no longer accurate (see BioCentury, July 4, 2011). In 2008, WHO updated its recommendations following concerns of under-dosing and drug resistance. ...