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Occurrence, Management, and Risk Factors for Adverse Drug Reactions in Multidrug Resistant Tuberculosis Patients

Nafees Ahmad1, Arshad Javaid2, Syed Azhar Syed Sulaiman1

  • 1Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Pulau Pinang, Malaysia.

American Journal of Therapeutics
|March 4, 2016
PubMed

Insights

Adverse drug reactions (ADRs) are common in multidrug-resistant tuberculosis (MDR-TB) patients in Pakistan, but rarely impact treatment outcomes. Patients with a baseline body weight of 40 kg or more are at higher risk for ADRs.

Area of Science:

  • Infectious Diseases
  • Pharmacovigilance
  • Clinical Medicine

Background:

  • Pakistan faces a significant burden of multidrug-resistant tuberculosis (MDR-TB).
  • Limited data exists on the prevalence, management, and risk factors for adverse drug reactions (ADRs) in Pakistani MDR-TB patients.
  • Understanding ADRs is crucial for optimizing treatment and patient outcomes.

Purpose of the Study:

  • To evaluate the occurrence, management, and risk factors for ADRs in MDR-TB patients in Pakistan.
  • To assess the impact of ADRs on treatment outcomes.
  • To identify patient characteristics associated with increased ADR risk.

Main Methods:

  • An observational cohort study was conducted at a drug-resistant tuberculosis management unit in Peshawar, Pakistan.
  • 181 MDR-TB patients were enrolled between January 2012 and February 2013.
  • Patients were followed until treatment outcomes were reported, with ADRs identified through clinical and laboratory data.

Main Results:

  • A high prevalence of ADRs was observed, with 131 patients (72.4%) experiencing at least one ADR.
  • Gastrointestinal disturbances (42%), psychiatric disturbances (29.3%), arthralgia (24.3%), and ototoxicity (21%) were the most common ADRs.
  • Baseline body weight ≥ 40 kg was the only identified risk factor for ADRs (OR = 2.321, P = 0.013).
  • Potentially life-threatening ADRs like nephrotoxicity (2.7%) and hypokalemia (2.8%) were less common.
  • ADRs led to treatment regimen modification in only 11% of patients and did not negatively impact treatment outcomes.

Conclusions:

  • ADRs are highly prevalent in Pakistani MDR-TB patients but generally do not lead to permanent treatment discontinuation or adverse outcomes.
  • Patients with a baseline body weight of 40 kg or more require closer monitoring for ADRs.
  • This study highlights the need for vigilant monitoring and management of ADRs in MDR-TB treatment programs.

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