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)
- 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.