I agree completely, but the patient should also be made aware of the potential risk with that specific drug. Some of the BB warnings are problems that most patient would never fathom could be a result of that drug. ie. ruptured tendons from an antibiotic, or increased suicidality from an antidepressant.

A doc can still prescribe a drug with a BBW, and in a manner that “invokes” the BBW. If the doc could not prescribe the drug under any circumstances in that situation, it would be a contraindication. A BBW is an extra serious warning not a contraindication.

Sad isn’t it. My experience with researching compliance in prescribing drugs with BB warnings, is that most doc dismiss the warning, or don’t even know about it in the first place. Which begs the question…..where do they get their drug information from?

I suspect that this reflects all your options, just as the rest of the label has been shown to have little impact on rx’ing in a great many instances, particularly in the absence of
a highly publicized study and/or media event related to the drug.

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=35406

Of course, even if there are more wolves, there is a point at which people get wolf fatigue.

Remember the Milgram experiment machine? Maybe we need:

Black Box
Severe Black Box
Extremely Severe Black Box
XXX Black Box XXX - Caution!!!!!!
Fuggedaboudit Box

or not.

*First the FDA was involved in a CRADA with Pfizer over the manufacturing and quality control of Dilantin (reported two months before the NEW drug was distributed to consumers and which we dug up after the fact).
*Then they offered up that they were not able to review the ridiculously limited study before Pfizer proceeded- but gave approval anyway (under the generics division even though it is still considered a branded drug).
*Then they seemingly ignored the reported AEs.
*Then we started reporting to EVERYONE because we got NO help from Pfizer or the FDA.
*Then they called epileptics depressed overall (many thanks for their contribution toward keeping us well, btw).
*Then they tried to include a BBW for suicidal thoughts and behaviors of epileptics, which incidentally, was based on some pretty small numbers that could probably be found in almost any group. Thankfully it was shot down, but not because of the patients I’ll bet. It would have damaged the industry.

The FDA approved a drug to be changed which is particularly dangerous to change. Do they think we’re making that up? Because there is plenty of evidence about the nature of these drugs which has led to much bustle for new legislation to protect people from being changed to generics. But what, it’s okay for the FDA to allow us to be switched to Pfizer’s new generic Dilantin? Or Pfizer to benefit from this legislation and have protection for their sales so they can have their cake and eat it too?

Interesting but I didn’t see phenytoin on the list of proposed BBW drugs (did I miss it?) even though it is one of the most commonly prescribed epilepsy drugs for epilepsy. Then it is said that the intent of the study was only for epilepsy purposes. I think the phenytoin omission was by design.
Don’t mention Dilantin for the love of God!

While Pfizer is most likely sitting there awaiting the ruling for preemption (the premise being that the drug was reviewed and approved by the FDA) I am waiting to see how hard it will be to make our case exempt from that ruling if it passes. The FDA didn’t handle the approval properly and I am certain that we have plenty of evidence to at least warrant consideration.

Still, it is Pfizer that we hold responsible. They chose not to warn us or our doctors in advance and placed us in a very dangerous situation, and then denied the problem. If the FDA/Pfizer CRADA created an atmosphere toward FDA encouragement of the change then Pfizer can deal with them.

Seriously, what good does a BBW do if the doctors do not know what they are prescribing? In our case the docs were blindsided and many had to be informed by their patients of the change after treating us with Dilantin for decades. It should have been hollered loudly and months in advance (maybe even with some of those TV ad dollars) for our safety. The docs didn’t do anything differently. We endured a lot of eye rolling from misinformed pharmacists. But the evidence does exist and grows daily. People were and are being damaged. A broad statement as to our state of mind does not change that.

Of course this is only my opinion. In case anyone was wondering, I don’t work for anyone, I am simply a patient who was severely wronged.