About ADRES
|
ADRES is based on adverse events (adverse drug reactions or ADRs, side effects, etc.) reports filed with the FDA.
The FDA provides these reports as a part of the FDA’s Electronic Reading Room
for documents frequently requested by the public. These reports are available as a part of the Freedom of
Information Act.
The FDA receives adverse drug reaction reports from manufacturers as required by
regulation. Health care professionals and consumers send reports voluntarily
through the MedWatch program. These are evaluated by clinical reviewers in the
Center for Drug Evaluation and Research (CDER) and the Center for Biologics
Evaluation and Research (CBER) to detect safety signals and to monitor drug
safety.
|
The FDA makes the following comments about this database:
CAVEATS
For any given report, there is no certainty that a suspected drug caused the
reaction. This is because physicians are encouraged to report suspected
reactions; however, the event may have been related to the underlying disease
being treated, or caused by some other drug being taken concurrently, or simply
occurred by chance at that time.
Accumulated reports cannot be used to calculate incidence (occurrence rates) or
to estimate drug risk. Comparisons between drugs cannot be made from these
data.
|
We concur with the FDA’s caution when reviewing this information. Keep in mind
that this database does not contain the number of people who took a particular
drug; there is no way to calculate the risk of any specific adverse event.
However, relative risks can be estimated for various important factors.
Consider the following hypothetical example: Drug A is reported as having 10
adverse events, such as: headache, nausea, constipation, etc. Let’s say that
for 9 out of the 10 adverse events, females experienced 10% more adverse events
than men. Here is what one of those nine adverse events might look like:
Adverse Event : HEADACHE
Women 110; Men 100
However for adverse event #10, i.e. Constipation, males had twice the
events of females. It would look like this:
Adverse Event : CONSTIPATION
Women 100; Men 200
One might conclude that Drug A is associated with increased constipation in
males. Does that mean that Drug A caused constipation in males? Not
necessarily; it could be that other factors play a role in causing this adverse
event in males. For example, males tend to take Drug A in combination with Drug
B, which might be the culprit drug in this case.
Similar analysis can be made for comparisons of adverse events between age
groups. Other important information can be gleaned by analyzing trends over
time. We urge caution when interpreting these reports, and strongly advocate
consultation with a healthcare professional before reaching any conclusions.