YES! There is a place to report adverse side effects of medications!
Medications – we’ve all been on them at one time or another. When they are prescribed an informational sheet is given to you explaining the side effects, drug interactions, and other pertinent information. Over-the-counter medications have labels telling one how to take them and what to watch out for, etc.
So we read up on the medication and begin taking them until we discover that that med is creating more havoc with our body than one wants to think about. One then find themselves saying – this just shouldn’t be – I want to inform others and FDA of what this med did to me. Well, guess what? You can do just that!
What is MedWatch?
MedWatch is the FDA Safety Information and Adverse Event Reporting Program and the place to go to report adverse side effects of medications whether they are prescription drugs or over-the-counter meds, supplements, food/beverage, medical devices, and more. It’s a place to get your experience and voice heard.
Outlined below is what you can and can’t report on the site. However – go to the MedWatch site to get the links of where you can report the “What Not to Report to MedWatch” topics.
What you can report to FDA MedWatch:
- Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for:
- Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
- Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
- Medical devices (including in vitro diagnostic products)
- Combination products
- Special nutritional products (dietary supplements, infant formulas, and medical foods)
- Foods/beverages (including reports of serious allergic reactions)
What Not to Report to MedWatch: (see the MedWatch site for links to topics below)
- Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS)
- Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
- Mandatory reporting by regulated industry – Drugs and Biologics & Devices
- Reporting on Dietary Supplements
- Reporting on Veterinary Medicine Products
- Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) and Where to Send Them
As you can see from the list above – one doesn’t have to be taking a prescription med to be able to file a report. You could be taking a supplement and find yourself wanting to make a complaint on the side effect that you’ve experienced.
And remember – just because there’s no concrete evidence of the side effect you’re experiencing doesn’t mean it doesn’t exist. No two bodies are the same in any way, shape, or form. Our chemistry makeup is all unique to each of us. Thus, we can all have a different experience when taking a medication. So don’t be afraid to get your issue heard.
The other piece to note is that clinical trials of a medication is just that – a trial. It doesn’t last for years or decades. It also doesn’t consist of every computation out there of what each individual takes for medications at the same time as a drug causing one an adverse effect. For instance, one may be on Nexium, Flexeril, and Prozac – yet the trials don’t include people taking all of those meds at one time and/or for the length of time someone may by on them.
Filling out a MedWatch Report
Filing a report is extremely easy on the MedWatch site. First chose the “Report a Problem” icon and then choose “Consumer/Patient” Icon. From there – answer the questions and fill in, in your words, what you experienced. Four thousand (4000) characters are allowed to get your point across. It’s very important that you list all the details you can. Take the time to do that – it only helps the FDA understand the complaint better and could save others from having the experience you did.
The MedWatch site is full of useful information aside to being able to report adverse side effects of medications. Educate yourself on the site – you may need to reference it one day.