Although the advantages of a postmarketing surveillance
system are self-evident, it is also important to consider the associated limitations, which include difficulties with adverse event recognition, underreporting, biases and report quality.
Experimental efforts are now underway to attempt postmarketing surveillance
of drugs using EHR data.
Although all 28 people appeared to have clinically experienced an immediate hypersensitivity to an allergen, our postmarketing surveillance
could not demonstrate that the Cry9c protein was actually in the product consumed prior to the adverse health event.
The major components of the Act are increased data requirements for devices submitted under a 510k, requirement for increased postmarketing surveillance
, establishment of registries for some devices, and more rigorous reporting of serious adverse events associated with the use of devices.
Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance
in individuals receiving Afluria[R].
In response to this need, over the last several years there has been a steady increase in the number of regulatory requests/requirements for postmarketing surveillance
studies for new medications likely to be used by women of reproductive age or by pregnant women.
But it took 5 years of postmarketing surveillance
before that benefit was recognized.
Identifying possible adverse events associated with the use of a dietary supplement product is accomplished by conducting safety evaluations in preclinical (namely, animal) testing, before monitoring for adverse events in human clinical studies and postmarketing surveillance
Because Taiwan lacks diagnosis and postmarketing surveillance
system, BCG-related complications might be underreported.
In the postmarketing surveillance
of Acomplia the safety profile of the product is aligned to the one described in the current European SmPC for the product and is consistent with the one observed during the clinical development.
Although anyone can report an adverse drug event (ADR) to MedWatch, the authors indicated that the most common bias in this database is underreporting, as only 1%-10% of adverse events are reported to this postmarketing surveillance
Mandatory postmarketing surveillance
is needed to address off-label prescribing that is unsupported by evidence, authors of an Agency for Healthcare Research & Quality-funded study say, The Pink Sheet reports.