sorry I haven't replied--haven't checked my email or the site in a few days--having a rough time.
This is GREAT. We need to doublecheck the manufacturer--as I think I've seen someone other than Bayer associated with the device.
How the black box warning works is, the FDA will require the manufacturer to supply a med guide separate from what usually comes with the drug. I don't know for sure if the doctor is then required by law to provide the patient the information or not. I would assume so, BUT this is not necessarily true.
This is why I suggested 2 -petitions--1 to AMA for full disclosure and 1 to FDA for black box warning. I'll see if I can find the exact details for the law/requirement, but I'm pretty sure it's more a check on the manufacturer than the doctor. I don't think anyone is enforcing the distribution end. The med guides have to be submitted to the FDA for black box drugs, so that end is enforced, I know.
I think with 2 petitions, we keep the text shorter, keeping the emphasis on the fact that serious side effects are occurring(FDA), and that doctors are not informed/responsive to patient issues (AMA).
We can use all the content you've got here (GREAT BTW) if we do this.