Spontaneous reporting systems like
MEDWATCH can be effective in revealing unusual or
rare adverse events that occur with the use of medications, and such
reports may often be sufficient to assign causality. However,
spontaneous reports do not reliably detect adverse drug reactions
(ADRs) that occur widely separated in time from the original use of the
drug or that represent an increased risk of an adverse event that
occurs commonly in populations not exposed to the drug. In these
situations, spontaneous reports alone do not provide sufficient
evidence to conclude that the adverse event was an ADR. Identification
of ADRs associated with long-term administration of drugs for chronic
diseases also remains problematic. Methods to evaluate ADRs using data
from clinical trials, medical records, and computerized databases of
medication users and nonusers must be developed to complement
spontaneous reporting systems. Without these methods, potentially
important ADRs will remain undetected, and spurious associations
between adverse outcomes and medications or devices will remain
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