Safety of proton pump inhibitors

Abstract

Proton pump inhibitors (PPIs) are commonly prescribed for the management of upper gastrointestinal tract disorders, and over 2 decades of use have demonstrated that these drugs provide significant clinical benefits with very few serious acute adverse events. However, several recent reports have suggested that short-term and long-term PPI treatment may be associated with certain risks. Specifically, studies have demonstrated a modest magnitude of association (odds ratio <2) between PPI therapy and osteoporotic fractures, micronutrient deficiencies, inhibition of antiplatelet therapy, enteric infections, and pneumonia. In response to some of these studies, the US Food and Drug Administration recently required labeling changes that reflect several of these potential risks. While available studies suggest a possible association between various risks and PPI use, demonstrating a causal link is difficult due to the absence of randomized controlled studies, heterogeneity among available studies, inconsistency of findings, and presence of confounding factors. As with all drug therapies, therefore, clinicians need to weigh the benefit of the therapy against any potential risks. Overall, the absolute risk for the majority of patients is small, and the benefits of these drugs often outweigh their potential risks.