Adverse Drug Event Reporting

I realize this may not be an appropriate forum for a discussion of this topic, since it's not directly related to ITP.
I won't ask my question until I get the okay.

Janet, I don't see why not if it's an ITP treatment or related in any way. Ask away!

Thanks, Sandi.

I remember you saying your doctor refused to report your Rituxan adverse event(s). Mine apparently is being more of a chicken about it, averting his eyes and muttering "the nurses take care of that". But they're giving me excuses and blowing me off without saying directly they won't report. For months, they've told me "the company" hasn't yet sent the form for them to fill out and return. How lame is that? And why does it even matter that Genetech gets a report? They'd just push it to the bottom of a file drawer and wait for 60 Minutes to find it a decade from now.
When I told them I didn't care what Genetech thinks and that I want it reported to FAERS, I was told it wouldn't change anything ... A sort of "what's done is done" bogus excuse.

So it appears I'll have to do this myself. However, on the webpage where the form is accessed, there is also a paragraph headed Mandatory Reporting for Regulated Industry and User Facilities. Does "user facility" mean the infusion center/operators? In other words, HIM and his staff?
Here's the link to the page I'm referring to:
www.fda.gov/Safety/MedWatch/HowToReport/default.htm

If what I understand is correct, that he's obligated to report, I fully intend to hold their feet to the fire on this.

I think Rituxan is a high profit drug for oncology centers that they push this quite a bit.

For me I did not want to take days off for transfusion so I said no. My hema brings up rituxan every time and I dont know why?

With promacta and NPlate showing such excellent results, rituxan should go the way of danazol\cyclosporin etc.

I don't know, Janet. It's been years since I reported my reaction to the FDA. It looks like maybe you'd use this form.

www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf

This is why I don't trust lists of side effects for any given drug. They are inaccurate and incomplete. Way too many side effects go unreported.

How are you doing?

Yes, dru... Money really is the root of all evil. I don't doubt that frequently happens.

Yes, Sandi. I found the right form. But do you have an opinion on the wordage at the bottom of that page as to whether the "user facility" would be the place the infusion took place and whether it's mandated to report?

There's been no improvement in the wobbliness in weeks. By sheer coincidence, I was in the company of a cousin-in-law last night who, unknown to me, has been battling vestibular disease for a long time. He describes his symptoms exactly like mine. The feeling of being drunk without the buzz, etc. He underwent therapy that taught him how to manage. He drives! And lives his life almost like a normal person. I can't tell you the hope I found in his story.

Last week, I brought up my Sjogren's symptoms with my PCP. At first, she didn't want to do the SSA/SSB testing and said ANA would be enough. After more discussion, she did order all of them. ANA is 1:80, sed rate is sky high, SSB 0, but SSA is 21 on a range where <29 is negative. It isn't positive, but IMO it's not exactly negative, either. Could be other things, but it's definitely something. Will need to see a rheumologist for answers.

Janet - I would imagine that user facility would be where you had the infusion done.

I'm sorry that you aren't any better, but glad that you have hope. There are exercises to do to try to re-balance your head. I know nothing about it, but have heard about it.

The ANA is fine. It's borderline, but tends to get higher as we age. What was the SED, do you know? Mine is usually pretty high too. You obviously have inflammation going on. You have an appointment with a Neurologist, right?

Sed rate 82 (ref rng 0-30)

Neuro appt will be August 21.

Yeah, that's pretty high.