Pursuant to the posting earlier this week which noted the rate of drug safety alerts out of the FDA, there also this week was a story published at CNNMoney.com that raises the very valid question whether or not patients and the prescribing public aren’t suffering from Warning fatigue. It is related to a question raised here before whether or not the dreaded Black Box Warning even serves notice to patients anymore regarding a safety signal.
Part of it, as the CNN story points out, relates to FDA credibility and whether or not the agency is regarded as a reliable source of information by the public. But I think the greater issue is the sheer volume and the lack of a clear standard for a safety alert situation.
After all, there is no drug without risk. Even over-the-counter medications – those which are cleared for purchase by consumers because they can administer them without the intervention of a learned intermediary (doctor) pose serious risks. Take acetaminophen tablets when you are feeling lousy with a cold or flu, coupled with another liquid medication that also contains acetaminophen and you can cause serious, even fatal problems. Too many aspirin can cause internal bleeding. Even too much of a vitamin can be a bad thing. When do you not issue an alert, and more importantly, when do you issue an alert.
Right now, the answer to the second question almost seems to be that you issue an alert when you think Congress is going to want you to issue one. A number of factors, including some the fault of FDA leadership, have led to a Congress that is exercising oversight in a most micro fashion. It is going to be one of the many serious tasks of the next FDA Commissioner address that and to re-establish some standards that communicate safety issues to the public that do not lose their valuable meaning over time.