Drug safety issues focusing on liver and pancreas toxicity

Thamir M Alshammari, University of Rhode Island


Background. Medications benefit people with diseases and medical conditions, improving many patients' lives and in some cases significantly increasing their quality of life. Despite these great benefits, medications can lead to serious adverse effects. Adverse drug reactions (ADRs) are the 4th leading cause of death, greater than major killers including pulmonary diseases, diabetes and automobile death. Objectives. Drug safety is a very important issue in patient therapy. Since antibacterial agents in general and fluoroquinolones specifically are among the most prescribed medications, it is very important to quantify their risks in causing serious adverse reactions such as hepatotoxicity and pancreatitis. The objectives of the three proposed manuscripts of this dissertation were to (a) estimate the risk of hepatotoxicity associated with fluoroquinolones use; (b) examine antibacterial agents use and the risk of acute pancreatitis development; (c) review the healthcare databases in United States and European countries that are commonly utilized in conducting epidemiological research. Methods. Two matched case control studies were used to examine the risk of hepatotoxicity and acute pancreatitis development with using fluoroquinolones and antibacterial agents, respectively. The Veterans' Affairs (VA) medical database was used to perform the two studies. Odds ratios (OR) and their 95% confidence intervals (CI) were derived from crude and adjusted conditional logistic regression models. In the third paper, a literature search was performed using Publisher Medline (Pubmed), Embase ® and the Iowa Drug Information Services (IDIS) to perform a review of four medical databases including the Nationwide Inpatient Sample database, the Veterans' Affairs medical database, the Health Improvement Network database and the Norwegian medical database. Results. In the first study, fluoroquinolones use was associated with increased risk of hepatotoxicity. However, only ciprofloxacin was statistically significantly associated with development of hepatotoxicity. In the second study, use of antibacterial agents was associated with increased risk of acute pancreatitis. Conclusion. The findings from both studies show that antibacterial agents are associated with increased risk of hepatotoxicity and acute pancreatitis. Knowing the safety of medication is very important for the clinical practice especially for antibacterial agents since they are commonly used and clinicians are considering these agents very safe.

Subject Area

Pharmacy sciences|Epidemiology

Recommended Citation

Thamir M Alshammari, "Drug safety issues focusing on liver and pancreas toxicity" (2010). Dissertations and Master's Theses (Campus Access). Paper AAI3415510.