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Jan 05, 2013 at 11:45am IST

US: Food and Drug Administration okays new drug that fights drug-resistant TB

Mumbai: It's a breakthrough. A new line of treatment for multi-drug resistant (MDR) tuberculosis has been approved by the US Food and Drug Administration for the first time in 40 years. Tested on 440 patients in the US in two phase-II clinical trials, the drug Sirturo could prove to be a game changer.

Dr Zarir Udwadia, a TB specialist at Hinduja Hospital, said, "We've had antibiotics but this is a new class of drugs, it acts by specific and new mechanism.. So it is the first new TB molecule which is going to be reserved for MDR TB as well. Since it is a new molecule there is going to be no resistance upfront at all. Our job as physicians is to ensure it is very responsibly used."

In hospitals, India has been grappling with MDR and the XDR forms of TB - which does not respond to any known treatment. Currently this new drug is approved only for the United States, but doctors in Mumbai have written to the manufacturers to make it available on compassionate grounds to a very critical patient in India who has not responded to standard treatment so far.

The World Health Organisation (WHO) says India has the largest incidence of drug resistant TB in the world. In 2010 officially 63,000 people got infected with MDR TB in India. Right now, the treatment for MDR TB is a two-year course of up to 20 pills a day and around eight months of daily injections. Doctors say that just as with any medicine, the new drug Sirturo also has side effects.

Dr Petros Isaakidis, an epidemiologist and Researcher at Medecins Sans Frontieres (Doctors Without Borders), says, "There are concerns about the Cardio Toxicity of the new drug. In rare cases, the drug could lead to an abnormal heart rhythm, cause nausea, joint pain, and headache. Side effects of the current regimen are so wide and so many, starting from hearing loss, neuropathy, some of our patients get crippled, they can be fatal, bad psychiatric side effects including getting suicidal.. get you blind, anemic. There is no 100 per cent safe drug."