Every company that manufactures an FDA-approved or FDA-cleared drug or medical device has an obligation to report “Adverse Events” to the FDA. For example, let’s say you’re taking Drug X and you start to develop a rash. If you call the manufacturer and tell them about it, they have to document what you tell them and investigate whether or not they think your rash is related to the drug, and whether or not your rash is serious.
The FDA makes those companies report certain adverse events to the FDA. The FDA then examines the adverse event reports and tries to look for both problems with individual batches of drugs, and with drugs in general. For instance, let’s assume that there have never been any instances of a bacterial infection occuring among people who took a certain drug. Then, all of a sudden, 25 instances of that infection occur within a month. The FDA is going to investigate to determine whether a specific batch of drugs may have been contaminated.
Or, perhaps there is a slow but steady trickle of people who are having heart attacks while taking a certain drug. Eventually, the FDA may investigate and determine that the drug causes heart attacks.
As I mentioned, you can call a manufacturer and report your experience to them. Or, you or your doctor can contact the FDA directly to report an adverse event. Here’s how to report an adverse event.
I encourage you to report any adverse events because without that kind of information, neither the FDA nor the manufacturer of the drugs you’re taking can tell that there might be a problem with their drug. All information about you (your name, address, etc.) will remain private.