Gastroesophageal reflux with romosozumab (Evenity)
Evenity (romosozumab) has been associated with gastro-oesophageal reflux disease as an adverse event in clinical trials, but it is rare. [1] The FDA prescribing information describes multiple warnings and adverse events, but gastro-oesophageal reflux disease is not presented as a common adverse reaction. [2]
Evidence of gastro-oesophageal reflux disease in clinical trials
ClinicalTrials.gov adverse-event tables for romosozumab trials report gastro-oesophageal reflux disease rates that were very low. [1]
- In one placebo-controlled romosozumab trial (NCT01575834), gastro-oesophageal reflux disease occurred in 0/3576 (0.00%) with placebo and 3/3581 (0.08%) with romosozumab. [1]
- In another trial (NCT01631214), gastro-oesophageal reflux disease occurred in 0/2040 (0.00%) with alendronate comparators and 4/2040 (0.20%) with romosozumab. [1]
Likelihood and clinical interpretation
The available trial evidence supports a rare occurrence pattern rather than a frequent drug effect. [1] Temporal association between starting romosozumab and new/worsening reflux symptoms can still occur given reported events in trials. [1]
Labeling and safety information
The FDA label includes warnings for myocardial infarction, stroke, and cardiovascular death. [2] The FDA label includes adverse-reaction information based on clinical trial experience, without characterizing gastro-oesophageal reflux disease as a common adverse reaction. [2]
Practical implications for symptomatic reflux
Reflux symptoms emerging during romosozumab therapy warrant clinical evaluation for other causes of upper gastrointestinal symptoms. [1] Severe or progressive symptoms require urgent assessment to exclude complications such as esophagitis or bleeding. [1]
Reporting of suspected adverse reactions
Suspected adverse reactions should be reported to pharmacovigilance systems to support ongoing characterization of romosozumab safety. [2]
Key Takeaway
Evenity can cause gastro-oesophageal reflux disease, but the event has been reported at very low frequencies in clinical trials. [1]