Washington: US Food and Drug Administration (USFDA) on Monday approved Johnson & Johnson`s drug for treating multidrug-resistant tuberculosis - the first such federal approval aimed at tackling the deadly disease in 40 years.
The drug named Sirturo - known chemically as bedaquilineas – is an alternative treatment for adults suffering from TB when two more powerful medications that are available, isoniazid and rifampicin, do not work, FDA said. However the regulator cautioned that the new drug should be used sparingly.
The FDA said Sirturo will carry a boxed warning to alert patients and health professionals that the drug can affect the heart`s electrical activity, which could lead to an abnormal and potentially fatal heart rhythm. The warning also noted deaths in patients treated with Sirturo and that nine patients who received Sirturo died -- compared with two patients who received a placebo.
TB is an infection caused by Mycobacterium tuberculosis and is one of the world`s deadliest diseases. It is spread from person to person through the air and usually affects the lungs, but it can also affect other parts of the body such as the brain and kidneys.
With Agency Inputs