Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors

Description

Jordi Mestres examined drug safety reporting in 2024 for a family of cancer drugs known as PARP inhibitors. Safety databases hold tens of millions of reports linking drugs to side effects, filed by both clinicians and patients. Safety signals are flagged when an effect is reported unusually often for a drug. Mestres merged four large databases and compared who files reports for five related drugs and who reports eight known side effects.

Clear source patterns emerged. Two drugs were reported mostly by doctors, who also report certain blood and lung effects most often. Two others were reported mostly by American consumers, who report sleep and bowel effects most often. When reporter type matches on both sides, a signal can appear even without a true drug effect. Mestres warns that signals born from matched reporting habits should be challenged during review, and class-wide signals need correction for these opposite patterns.

Catalog record

Source: https://europepmc.org/articles/PMC12443103