Physicians may soon have another drug in their armamentarium to treat highly drug-resistant tuberculosis (TB).

The US Food and Drug Administration (FDA) has approved Pretomanid tablets in combination with bedaquiline and linezolid for the treatment of adult patients with extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant  (MDR) pulmonary TB. It is to be taken orally over six months.

Adverse effects: Peripheral neuropathy, acne, anemia, nausea, vomiting, headache, increased liver enzymes (transaminases and gamma-glutamyltransferase), dyspepsia, rash, hyperamylasemia, visual impairment, hypoglycemia and diarrhea.

Contraindication: Hypersensitivity to bedaquiline or linezolid

In a study of 109 patients with XDR TB, treatment intolerant or non-responsive MDR pulmonary TB, a success rate of 89% was observed six months after the end of treatment with oral pretomanid + bedaquiline + linezolid.

Pretomanid has also been designated as Qualified Infectious Disease Product (QIDP) by the FDA, which is assigned to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

(Source: US FDA)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA