February 22, 2012 — The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) agrees with the World Health Organization (WHO) dosing recommendations for ethambutol, isoniazid, pyrazinamide, and rifampicin as first-line antituberculosis medicines used in children, according to new EMA dosing guidelines released February 17.
Tuberculosis is most prevalent in developing countries, but still occurs in some European Union member states, with the average notification rate for tuberculosis in 2008 being 16.7 per 100,000 population in the European Union and European Economic Area region.
In 2008, the WHO recommended changes to pediatric dosing, which the French medicines agency then reviewed in 2011. This review did not include multidrug-resistant tuberculosis. Pharmacokinetic data had shown that weight-based dosing regimens for use of antituberculosis medicines in children might lead to suboptimal exposure if based on corresponding adult weight.
In light of limited evidence to date and various other considerations, the CHMP acknowledged that the pediatric dosing regimen of first-line antituberculosis agents is difficult to define. This is particularly true for infants younger than 3 months because specific data are lacking.
Nonetheless, the CHMP agreed with WHO dosing recommendations for children older than 3 months, as follows:
ethambutol: 20 mg/kg (range, 15 - 25 mg/kg),
isoniazid: 10 mg/kg (range, 10 - 15 mg/kg),
pyrazinamide: 35 mg/kg (range, 30 - 40 mg/kg), and
rifampicin: 15 mg/kg (range, 10 - 20 mg/kg).
"The review aims at optimising therapeutic management of the disease in the European Union and harmonising dosing in order to encourage the development of fixed dose combinations (FDC) by pharmaceutical companies," the news release states. "FDCs are important as they can improve how well a patient is able to follow medical advice in terms of taking medicine at the right time and taking the correct number and combination of tablets. This can be especially challenging with children."
The CHMP intends to share its opinion statement regarding dosing recommendations with the European Union member states, so that they can implement appropriate policies at the national level.
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Cite this: EMA Recommends First-Line Anti-TB Drugs for Children - Medscape - Feb 22, 2012.
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