We ask reviewers to check that these
reports of adverse drug events include:
- Age and sex of patients
- Suspected drug and all drugs currently
being taken with start, stop, and restart dates; and outcome.
Generally something more than simple coincidence in time is required:
rechallenge with the patient’s informed consent, or immunological
investigations may tip the balance of probabilities.
- Prior experience with drug or adverse
reactions to related drugs
- Other diseases and environmental
factors and their timing
- Ancillary information from
pharmaceutical company and regulatory agency
- All published reports
- Other factors relevant to verify
specific types of adverse drug reactions (for example, blood
concentration in overdose, baseline laboratory data, ethnic group)