Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database

Abstract

The existence of a notoriety bias has an impact on measures of disproportionality. The detection of pharmacovigilance signals might be delayed. It is advisable to list all drugs being taken when an adverse drug reaction occurs, and not only those known to be associated with the observed reaction.

Social media and pharmacovigilance: A review of the opportunities and challenges

“…Furthermore, it is natural to expect that the reporting medium may affect the reporting rate of a specific event. For instance, a patient suffering from impotence may be less likely to post this on a social media site. Notoriety bias may occur as a result of publicity or because the drug has recently been introduced onto the market, a notable example being bisphosphonates and osteonecrosis of the jaw . Sertindole is an atypical antipsychotic that was suspended due to such bias.…”

Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database

“…Furthermore, public available SRS databases are plagued by reporting artefacts, biases (e.g., notoriety), recorded and unrecorded confounders (prominently by indication) and effect modifiers, and deficits in quality and completeness of information including duplicate reporting, which may escape proprietary duplicate detection algorithms. [44][45][46][47].…”

Pharmacovigilance evaluation of the relationship between impaired glucose metabolism and BCR‐ABL inhibitor use by using an adverse drug event reporting database

“…In addition to the possibility of an over‐reporting bias, an under‐reporting bias, due to nonreporting of adverse events by health care workers, exists . It is known that spontaneous adverse event reports tend to increase after drug safety alerts or publications, which is called notoriety bias . Considering these reporting biases, caution should be exercised when interpreting results obtained from only one SRS database.…”

“…32 It is known that spontaneous adverse event reports tend to increase after drug safety alerts or publications, which is called notoriety bias. 33 Considering these reporting biases, caution should be exercised when interpreting results obtained from only one SRS database. In our study, we used two SRS databases, FAERS and the JADER database, to overcome reporting biases and increase the reliability of our results.…”