Figure 1. This figure illustrates the number of reports received (solid bars) and entered (checkered bars) into AERS by type of report since the year 2000 until the end of the first quarter of 2010.
Most drugs have some kind of side effects. Sometimes the only way to learn about a drug’s side effects is to study the drug in a large population (larger than can be studied, pre-approval) and look at Adverse Events.
What do we mean when we talk about Adverse Events?
From A Guide to Drug Safety at the FDA:
- Any undesirable experience associated with the use of a medicine in a patient.
- Can range from mild to severe.
- Serious events are those which can cause disabiity, are life threatening, result in hospitalization or death, or cause birth defects.
From the Code of Fedral Regulations, Title 21, Volume 5, Revised as of April 1, 2009:
Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following:
- an adverse event occurring in the course of the use of a drug product in professional practice;
- an adverse event occurring from drug overdose whether accidental or intentional;
- an adverse event occurring from drug abuse;
- an adverse event occurring from drug withdrawal;
- and any failure of expected pharmacological action.
