Oct 062014
 
medwatch

YES!  There is a place to report adverse side effects of medications!

Report Adverse Side Effects

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)
    Cosmetics
  • 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.

 

  25 Responses to “Where to Report Adverse Side Effects of Medications”

Comments (25)
  1. That sounds like a great resource. I will keep this in mind!

  2. Great info. I did not know about this.

  3. I had no idea there was a place to report things like this. It’s fantastic that we can do that and help others out with our feedback.

  4. I think this is awesome! I just recently had been taking a new pill that left me with many bald spots and leaving me feeling really week. 2 months after being off of it my hair is starting to grow back and I feel 100 times better.

    • Alisha – I hear you. I was put on a med that after having the dose upped – it caused me severe mouth pain. It’s not listed as a side effect nor did the doc ever have a patient experience what I did. Needless to say – I came off the med and my mouth is fine now. Then my daughter was on an ADHD med for her ADD – at the higher dose, it gave her a severe social anxiety disorder. Again – not listed as a side effect. Now she’s trying to recover from 2yrs lost of socialization skills while being in her teens. It’s been a LONG journey for her.

  5. Wow. I never knew something like this existed. What a great resource for those who need it!

  6. The first thing I do when I have to take a new medicine is find out the side effects. I haven’t heard of MedWatch, but it’s good to know that there is a place to report when needed.

  7. This is good to know! I am glad there is a place where people can report side effects. It’s about time!

  8. My daughter is on a lot of medications and has had some pretty weird side effects from them. It’s nice to know there’s a place to report them.

  9. This is interesting info,I have been fortunate not to have adverse affects but will keep this info in mind thanks

  10. I’m so glad that you wrote about this. I have always wondered were to report information like this. Thanks for posting!

  11. It’s great to know that there is a program like MedWatch out there! I’ve never had any types of reactions to medications but my mom has, I will have to share this info with her!

  12. Thank you so much! This is such a helpful site that I will be using!

  13. I’m glad they made a platform to report adverse medication effects.

  14. It is important to keep track of the medications we take and how they interact with eacah other.

  15. As a medic in the army I always advise my soldiers to be careful whenever taking a new medication and to report any adverse effects besides reporting to the PA, in the event of a serious side effect we also give them the 800 number. Great advice here.

  16. This will be a fantastic resource for families. My son had a lot of adverse affects to the ADHD and ODD medication he was on, and I never knew where to report it.

    • That makes two of us Kathleen. The ADHD med my daughter was put on – once they upped her dose – she began expressing anxiety issues. Needless to say, despite all my efforts and no one wanting to listen to me – she was diagnosed two years later with a severe social anxiety disorder. She lost so much time all the way around as a teen.

  17. Medications are such unusual things. It can affect each person different. It’s good to know there’s a place to share and read about side effects.

  18. This is definitely a great resource. I can never believe how many warnings there are on commercials for prescription medications!

    • I know right. The sad thing is, is that there just aren’t enough studies done prior to their release nor are they long enough. Not to mention – I am sure they don’t have the ability to test each med with every other med on the market. Then when you add that – we’re all unique in chemistry – we really have to be in tuned with our bodies.

  19. I never knew that. That is such a fantastic idea.

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