eoe wrote:Here's a question...how many of the "warnings" on over-the-counter medications truly valid and how many are just the cover-their-ass variety?
There are two main categories, side effects and contraindications.
Side effects tend to be those things that have been observed during clinical investigations prior to being on-market, or in the case of some OTCs, while being prescription only. They may or may not have been directly attributable to the drug, but if a reaction was observed in sufficient numbers (say, 2 - 5% of the study population), or is a significant clinical event then it has to be listed on the label.
Contraindications are warnings that indicate who should not take the drug. This may be because of a known interaction with another medication, a known tendency to exacerbate an existing condition, or because the population was not included in the clinical trials (pregnant women, children, etc.)