The Mycobacterium tuberculosis TB bacteria is shown in a high magnification scanning electron micrograph SEM image.
However, the agency cautioned that the drug carries risks of potentially heart problems and should be prescribed carefully by doctors. Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U. Of Sirturo fdating, aboutsuccumb to the increasingly common drug-resistant forms of the disease.
Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of Sirturo fdating four primary antibiotics used for tuberculosis. The drug carries a boxed warning Sirturo fdating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.
Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four. Despite "Sirturo fdating" deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results. Last week, the consumer advocacy group Public Sirturo fdating criticized that approach, noting the drug's outstanding safety issues.
The FDA said it approved the drug based on two mid-stage studies enrolling patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis. Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.