MedWatch Voluntary Reporting Form

MedWatch Voluntary Reporting Form – the official FDA site for complaints

Another patient described on Pharmacist Steve’s blog how to word complaints about sudden, medically unjustified, reduction in opioid medication:

Here’s the blurb I came up with:

Withdrawal symptoms, and other adverse reactions, are considered a serious safety problem with medication, especially when this is happening as a result of a doctor abruptly discontinuing or inappropriately tapering your drug treatment in a way directed against in the medicine’s US FDA approved prescribing information.  

In the US, you are encouraged to voluntarily report this, and any other problems with medicines, to FDA at 1-800-fda-1088, or using the form provided in the link below.

This is one of the only ways that we as chronic pain patients have right now to have these instances documented officially by US government. FDA uses the data to detect trends (potential safety problems with medications) and works to mitigate them.

Below is from the FDA’s MedWatch Voluntary Reporting Form:

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

I’m constantly looking for places to send our complaints about how doctors are handling our opioid medications.

6 thoughts on “MedWatch Voluntary Reporting Form

  1. peter jasz

    Oh man: With respect to severe pain patients, let’s think about this:

    ” … This is one of the only ways that we as chronic pain patients have right now to have these instances documented officially by US government. FDA uses the data to detect trends (potential safety problems with medications) and works to mitigate them.”

    LOL.

    Sooo, the poor, gravely suffering patient (make no mistake I know) who struggles horrifically even with ‘adequate’ opiate supply (if that’s what works for them), are tapered, cut-off/withdrawn from opiates, what do YOU think happens next ?
    (That they sit around their peaceful, wood-burning ‘fireplace’ while their entourage await/create documents for some scum-ball in Washington (DC) …. as the estates gardener’s ‘tend’ to the lawn -and pool area?)

    OMG. NO. They are contemplating life. And death. Forced into a literal, honest, unimaginable living hell most people mercifully never experience, yet simply incomprehensible that it escapes the greater knowledge of the medical community. It’s reprehensible. And criminal. These fucking A-Holes know what happens. You think, they require patient “feedback”. Has everyone lost their fucking minds ?

    Crimes Against Humanity. Unimaginable. Unfathomable. And this, in times of ‘peace’ ?

    People responsible for such suffering should be jailed. In fact, tortured.

    This entire, disturbing debacle is nothing short of a living nightmare -perpetuated by the sociopaths granted the powers to make such damning policy/decisions. UGLY.

    peter jasz

    Liked by 2 people

    Reply
    1. Zyp Czyk Post author

      Yes, it’s absurd to have to organize formal complaints about such inhuman policies. How can anyone simply “decide” our pain doesn’t need treatment? It’s certainly not what they’d say if it was their own.

      Liked by 1 person

      Reply
        1. Zyp Czyk Post author

          I still don’t understand how the same AMA that went after alternative medicine as “practicing medicine without a license” hasn’t risen up to push back on this encroachment on their field. It shows they never really cared that others were “practicing medicine without a license” as much as they cared that others were making money.

          As long as the government doesn’t interfere with the doctors’ revenue stream, the AMA remains silent.

          It’s much more expensive (for patients) and profitable (for medical providers) to send patients to all kinds of ineffective therapies, treatments, and surgeries than to prescribe an opioid, so all these opioid restrictions are money-makers for doctors.

          Liked by 1 person

          Reply
          1. louisva

            I agree 100%. A good example is pain pumps. It requires surgery and every surgery has big risks, esp. for us older folk plus the dang things often screw up and have to be removed – another dangerous surgery. AND the physician makes big bucks!

            Liked by 1 person

            Reply
    2. louisva

      Excellent response, Peter! I’m tired, pissed off, and generally down on the powers that be. I had EXCELLENT pain relief for 8 years – then gone! I want Trump, Kolodny, and others behind bars. What happened to social justice for all?

      Liked by 1 person

      Reply

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