Descriptive Analysis of Adverse Drug Events of Three mTOR Inhibitors Using WHO-VigiAccess

The mechanistic target of rapamycin (mTOR) pathway regulates cell growth, metabolism, and survival. Its dysregulation contributes to cancer, autoimmune disorders, neurodegeneration, and aging. While mTOR inhibitors such as Sirolimus, Everolimus, and Temsirolimus are therapeutically valuable, they are linked to significant adverse drug reactions (ADRs).

To investigate adverse events (AEs) and ADRs associated with mTOR inhibitors using the World Health Organization's VigiAccess database.

A retrospective descriptive analysis was conducted using ADRs reports from WHOVigiAccess (2000 onward). Data included patient demographics and geographic distribution. Statistical measures such as odds ratios and relative risks were applied to assess risks.

Sirolimus showed a 132% increased risk of gastrointestinal (GI) hemorrhage, alongside oral ulceration, highlighting mucosal toxicity. It was also linked to a 67% higher risk of interstitial lung disease and a 63% increased likelihood of ascites. Temsirolimus was associated with a 40% higher risk of pneumonia and a 36% higher risk of sepsis, reflecting immunosuppressive effects.

The findings underscore the diverse and serious ADRs of mTOR inhibitors, ranging from gastrointestinal and pulmonary complications to heightened infection risk. These outcomes emphasize the need for careful monitoring and risk-benefit evaluation in clinical use.

mTOR inhibitors, while effective, pose substantial risks of ADRs including hemorrhage, lung disease, ascites, and infections. Clinicians should weigh therapeutic benefits against potential harms and adopt vigilant monitoring strategies to optimize patient safety.