Correlation of antituberculosis drug-related liver injury and liver function monitoring: A 12-year experience of the Taiwan Drug Relief Foundation

Abstract

Antituberculosis drug-related liver injury (ATLI) is the most prevalent hepatotoxicity in many countries. Whether monitoring liver tests is beneficial to prevent this potentially grave adverse drug reaction (ADR) is open to debate. The Taiwan Drug Relief Foundation (TDRF) was established by the Taiwan Food and Drug Administration to collect severe cases of ADR and carry out drug injury relief tasks. Our intention was to explore the role of monitoring liver tests in the susceptibility and severity of ATLI from the database of this foundation. All cases of suspected ATLI collected by the TDRF from 1999 to 2012 were reviewed. The basic demographic data, clinical course, and laboratory data of these patients were analyzed. A total of 57 cases with severe ATLI were verified and enrolled into this study. There was a high mortality (71.9%) in this cohort. Twenty-four cases (42.1%) were chronic viral hepatitis B carriers, who had higher baseline serum aminotransferase level than noncarriers. The patients without monitoring liver tests had higher peak serum alanine aminotransferase, bilirubin levels, and mortality (adjusted odds ratio, 8.87; 95% confidence interval = 1.32-59.41; p = 0.024) than those with monitoring liver tests. In conclusion, patients with severe ATLI whose records were collected by the TDRF have a high mortality. Patients without follow-up monitoring liver tests had more severe liver injuries and higher mortality than those with monitoring live tests. To alleviate this potentially grave ADR, checking of liver biochemical tests prior to antituberculosis treatment and periodic monitoring of these tests thereafter are highly suggested.

Using real‐world evidence for pharmacovigilance and drug safety‐related decision making by a resource‐limited health authority: 10 years of experience in Taiwan

“…These studies mainly focus on signals particularly important in Taiwan and less studied in other countries. For example, more attention will be paid to drug‐induced liver injury (DILI) since hepatitis B infection, a significant risk factor for DILI, is prevalent in Taiwan 65 . Similarly, drug‐related severe cutaneous adverse reactions (SCARs) are also an area of focus because they occur much more often in the Taiwanese population than in Caucasians due to different genetic backgrounds and is the most common type of adverse drug reaction apply for drug relief in Taiwan 37,66 …”

A Prospective Study on Abnormal LFT Patterns in Patients Receiving Antituberculosis Therapy

“…Elevation of the ALT is most specific for hepatic cells injury as its concentration in the liver far exceeds that in any other organ. Elevation of AST is less specific as it may occur also due to damage to skeletal muscle, kidney, brain, and red blood cells [5]. Hence, the present study aimed to evaluate the abnormal LFT patterns in proved cases of pulmonary TB in patients on short-term regimen of anti-TB therapy (ATT) as per RNTCP.…”

“…It is vital to consider drugs as a cause of LFT abnormalities. Test results patterns across several parameters are usually more useful than single parameters [5].…”

The value of eosinophil VCS parameters in predicting hepatotoxicity of antituberculosis drugs

“…Tuberculosis (TB) is recently regarded as a hazardous threat to worldwide public health. Regimen containing isoniazid (INH), rifampicin (RIF), ethambutol (EMB), and pyrazinamide (PZA) is traditionally used as the first line of therapy for TB . However, hepatotoxicity frequently develops in patients receiving these drugs .…”

“…However, hepatotoxicity frequently develops in patients receiving these drugs . Drug‐induced liver injury (DILI) is the most frequent cause of discontinuation of antituberculosis medication and remains difficult to predict, which may significantly increase morbidity and mortality . According to the criteria established by the International Consensus Meeting , DILI is defined as an increase in serum ALT level greater than twice the upper limit of normal value (ULN) during treatment.…”