How to Report Side Effects to the FDA

This week, MedShadow founder Su Robotti and content manager Jonathan Block take a look at the FDA’s reporting system for side effects from medications, medical devices, food, cosmetics and more. They walk us through the online MedWatch form for reporting, while mentioning that there are 3 other ways to get your information to the FDA if the form doesn’t work for you.

Su Robotti: Hello, and welcome to MedShadow TV. My name is Su Robotti, and I’m the founder of MedShadow.

Jonathan Block: Hi, I’m Jonathan Block, and I’m the content editor at MedShadow.

SR: Today, Jonathan came up with the idea for our MedShadow TV. He was looking at the FDA reporting site for when you have an adverse event or a very negative side effect for a drug or a medical device, and realized, it’s maybe not as easy as it looks. So he went through the process and he’s here to tell us a little bit about what it’s like.

JB: Sure, first of all, if you do experience an adverse event or a very serious side effect, the first thing you should do is to not report to the FDA but to contact your doctor or healthcare professional immediately so that they could take immediate action.

The system that Sue was talking about is known as the MedWatch system. This is the database that the FDA compiles from reports of side effects and adverse events from both patients as well as healthcare professionals. The good news is that you can actually access the MedWatch site by going to our homepage at medshadow.org, and on the right side of the page you will find a link to the MedWatch reporting site, which will allow you to submit a report to the FDA.

The first thing that you should know when doing this is that you should, if possible, have the medication available in front of you, because you’re going to have to enter in information such as the expiration date. You’re going to need to know the dosage that you are taking. Obviously, the name of the drug. The name of the manufacturer. This is all information that the FDA is going to want to know about when you are making your report.

When you do go to the MedWatch page, the first thing you’re going to do is, after clicking on making a report as a patient — because there’s another way to make a report, but that is for healthcare professionals — is they’re going to want to know a little bit more about the problem. They’re going to ask a series of questions where most of which you’re only going to have check boxes, such as — provide details as to why it happened, the date that it occurred, and if you have any test or lab data that are related to your condition and thus might be connected to the medication.

SR: But that’s a little bit tricky, as I was looking at it, just because you said it was so interesting. I noticed that if you report online, they don’t accept any attachments, so you’ll have to write down the information, any lab test that you got. However, there are 4 different ways to report adverse events to the FDA through Med Watch, and the easiest way is online, as Jonathan said. However, you can also printout the form, you can call the FDA with an 800- number, that’s on our screen now, and you can have your doctor report for you. That will be reported for you.

JB: Exactly, and the next step after, there’s a page where you describe your problem is to talk about the product that you’ve been taking. Just to go back a little bit, the reporting site is not just for prescription drugs–

SR: Prescription medicines, any food, because it’s FDA, Food and Drug Administration, biologics, things like blood, plasma, tissue, human cells, medical devices, any combination devices, special nutritionals, they do want to hear about infant formula or food for seniors. And cosmetics. You can complain about cosmetics there too.

I noticed when I was going through the form, that they seem to, they have check boxes on the website that ask were you hospitalized, did you die — presumably, did someone die. Were you disabled. The implication, if I were filling it out, and I wanted to complain that this pill made me extremely nauseous, or this pill give me a full body rash, or some complaint of that nature, that is a very valid adverse event or side effect to report to the FDA and to Med Watch. It doesn’t quite seem like that because it’s not one of the check boxes. They really want to find the big events. But those not so big events, are incredibly important for doctors to know about, and for the FDA to know about, so that they can really determine if these side effects are worth the benefits of the drugs over the long term.

JB: Exactly, exactly. As I was saying before, you do want to keep the medication that you’re using because another thing you’re going to have to fill out is the dosage that you’re taking, the name of the drug, how frequently you are taking it, the manufacturer, that sort of thing. And there’s a field to put that information in. And then there’s another page where they want to know more about you, as far as your age, your sex, obviously, your ethnicity, as well as any medical conditions that you might be suffering from as well as other medications that you are taking, as well as any nutritional supplements because there is a possibility that the side effect or adverse event that you’re experiencing could be related to an interaction with one of those other products that you are taking.

SR: Don’t forget to include everything even if it’s not asked about, if you’re taking herbal supplement–

JB: Correct–

SR: If you’re taking vitamin pills, those are all products that can interact, and don’t forget this also covers medical devices. So if you’re having a problem with knee replacement, a shoulder replacement or a hearing aid is a medical device, a crutch is a medical device, all legitimate to file here.

JB: Exactly, and then the last part that you’ll have to do is actually very simple. They’re going to ask for your name. You don’t have to give them your address, but I would suggest that you do that because they may want to, you know, be in contact with you via mail. I guess the bottom line is that if you do have an adverse event and it’s serious, absolutely, do report it.

It’s through this reporting that the FDA can investigate and take potential action against drug manufacturers in regards to a particular drug and by doing that you may very well be helping other people out, in terms of getting more research done on the medication.

SR: Well put, Jonathan. Thanks, and I think that’s it for MedShadow TV today.

JB: It is. Thanks very much, and don’t forget to check out our website at www.medshadow.org for more information. Thank you.

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