Three weeks ago you told the clinic about it. Whatever it was — the reflux, the headaches, the dizziness — the answer was that it is common early on and usually settles. It has not settled. The only number you have for this is the clinic's, and you have already used it once.
There is a second place it can go. The Food and Drug Administration runs a reporting program called MedWatch for problems with medicines and other medical products, and it takes reports directly from patients and consumers. Check what you have against the printed test for a serious problem, decide whether to file, and see what the form wants from you before you open it.
Call the clinic again first, because they are the only people in this who can examine you. Then file a report yourself if you want to. The program takes unexpected side effects of any size, the seven serious outcomes on FDA's list tell you how fast to move rather than who is allowed to file, and your clinician is under no obligation to file anything on your behalf.
Which problems FDA counts as serious
FDA counts a problem as serious when the patient outcome is one of seven, and the seven are printed in full:
- Death.
- Life-threatening — the person was at substantial risk of dying at the time.
- Hospitalization, either a new admission or a stay that got longer.
- Disability or permanent damage, meaning "a substantial disruption of a person's ability to conduct normal life functions".
- A congenital anomaly or birth defect, where exposure to a medical product prior to conception or during pregnancy is suspected.
- An intervention needed to prevent permanent impairment or damage, which is the entry for devices.
- Other serious important medical events: it fits none of the six above, but it may jeopardize the patient and may require medical or surgical treatment.
An emergency room visit that did not end in admission is named separately, and the instruction there is to weigh it against the other outcomes rather than to count the visit on its own. If you went and were sent home, check yourself against the other outcomes rather than against the visit. Read the seven with your own three weeks in mind — most of what people are told is expected touches none of them.
Missing all seven changes how fast you move on it, not whether FDA will take it. The program's scope is serious reactions, product quality problems, therapeutic failure and product use errors, and the online portal describes reportable side effects as "everything from skin rashes to more serious complications". If this is a medical emergency, call 911 — that line sits above everything else on the portal. Get the care first and file afterward.
Who can file a report, and what FDA does with it
Anyone can file a report — health professionals, patients and consumers all use the same voluntary program — and what FDA does with it is safety surveillance of the product rather than a reply to you. In FDA's own words it "relies on the voluntary reporting of these events", and a report "may be the critical action that prompts a modification in use or design of the product".
Your clinician is not required to report to FDA, and FDA prints that in capitals, because it is the assumption most people arrive with. Telling the clinic and filing a report are two separate acts, and doing the first does not do the second.
Filing needs no diagnosis, no established cause, and nobody's agreement that the medicine did it. The serious-outcome list is written in the language of suspicion throughout — report if you suspect, report if suspected. So an honest report says what happened and when, and leaves the weighing to the people who evaluate it.
What a report asks you for
A report asks for what the phone call never wrote down: the product you suspect, a brief summary of what happened, and, if you choose to give them, your own details. Consumers use Form FDA 3500B, which is the consumer version of the 3500 form health professionals use, either through the online portal or as a PDF you print and send.
Three details about the form save you a second attempt. Your contact information is not mandatory, though FDA encourages it in case they need to ask you more. You can request, inside the report, that FDA not release your contact information to the manufacturer. And once you submit, you cannot retrieve the report and edit it — adding more later means a new report that points back at the first. A part-finished report can be saved and completed within three days of starting it.
One instruction runs the other way, back toward the clinic. FDA encourages you to take the reporting form to your doctor, because a provider can add clinical information from your medical record that helps FDA evaluate what you sent. If they decline, or you would rather not ask, completing it yourself is expressly allowed. For questions, or to be talked through it, FDA's information line is 1-888-INFO-FDA, which is 1-888-463-6332, and then press 2.
Your three weeks, written down
- Write down what the symptom is, when it started, and what you were told the first time you raised it.
- Call the clinic with those three things and say it has not stopped. Whether anything about your treatment changes is theirs to decide, and they cannot decide it without knowing.
- Read the seven serious outcomes and mark whether yours touches any of them. If it does, that call is today's.
- File at MedWatch Online, or on Form FDA 3500B, with the product you suspect and a short account of what happened and when.
- Ask FDA, inside the report, not to release your contact information to the manufacturer, if you would rather it stayed with FDA.
- Take the form to whoever prescribed the medicine and ask them to add what is in your record.
- Call 1-888-463-6332 and press 2 if you get stuck partway.
Your report joins a count FDA reads to watch the product, and FDA may come back to you for more information, which is not the same as coming back with an answer. Nobody at an agency can examine you, which is why the form goes alongside the second phone call and never in place of it.
