Dr KK Aggarwal
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
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