In subject: The boilerplate warning for zillions of medications, even OTC ones (I think) like antihistamines.
Drug-release information specifications for prescribers and consumers is a hugely regulated process, with enormous implications and even financial impact, and is negotiated by the pharm legal department; a debate about even having a “black box” warning for anti-depressants, let alone the wording, made the NYTimes.
So:
- Is there an identifiable history and record of exactly that wording?
- If so, I’m particularly interested in what the definition/decision of “heavy machinery.” Any ideas?