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The Nurse Practitioner

March 2013, Volume 38 Number 3 , p 56 - 56



Janssen Therapeutics has received FDA approval for its new medication, bedaquiline (Sirturo), as part of a combination treatment for adults with multidrug-resistant pulmonary tuberculosis (TB) when other alternatives are not available. Bedaquiline works by inhibiting an enzyme that Mycobacterium tuberculosis needs to replicate.Bedaquiline carries a boxed warning alerting patients and healthcare professionals that the drug can cause QT prolongation. The warning also notes that deaths occurred in patients treated with bedaquiline in a clinical trial. Nine patients in the treatment arm and two patients in the placebo arm died. Five deaths in the bedaquiline-treated group and both deaths in the placebo arm appeared to be related to TB, but no consistent reason for the other four deaths in the bedaquiline-treated group could be identified.Bedaquiline's effectiveness was established in two clinical studies involving 440 patients. Common adverse reactions identified in the clinical trials included

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