Report adverse or no medication effects to the FDA

MedWatch Voluntary Reporting Form – for reporting adverse drug effects to the FDA

Perhaps the FDA doesn’t know how ineffective “alternative” non-opioid drugs are for pain because no one has told them. You can download a form from this site (link above) to report your experiences.

Use the MedWatch form to report adverse events that you observe or suspect for human medical products,including

  • serious drug side effects,
  • product use/medication error,
  • product quality problems, and
  • therapeutic failures

It’s this last category that presents our opportunity for action. We could report the “therapeutic failures” and awful side-effects of non-opioid medicaitons like Lyrica, gabapentin, or antidepressants for pain.

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 (infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions)

There are two forms, one for health professionals

and one for patients:

Here’s what the first page of the form for patients will ask:

About Problem

What kind of problem was it? (Check all that apply)

  • Were hurt or had a bad side effect (including new or worsening symptoms)
  • Used a product incorrectly which could have or led to a problem
  • Noticed a problem with the quality of the product
  • Had problems after switching from one product maker to another maker

Did any of the following happen? (Check all that apply)

  • Hospitalization – admitted or stayed longer
  • Required help to prevent permanent harm (for medical devices only)
  • Disability or health problem
  • Birth defect
  • Life-threatening
  • Death (include date) (mm/dd/yyyy)

Other serious/important medical incident:   (please describe)

Tell us what happened and how it happened:  (Include as many details as possible)

List any relevant tests or laboratory data if you know them:

Other thoughts?

Fill in your details below or click an icon to log in:

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