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Dear Nancy:The package inserts for drugs, called PPI's, are mandated by the FDA
to contain all the information that the medical practitioners need to know
before prescribing.  Whatever reactions noted in the three phase studies for
approval of the drug are duly noted; some of them are statistically
insignificant and should not unduly alarm the average patient.  Even if the drug
affects 1% of the people tested, that affect will be noted in the PPI.  That
identical information is also given in the PDR, the Physician's Drug Reference
which is getting more popular.
Michel


First & Last-Name wrote:

> does anyone know what the rule/law is regarding package inserts? i think it
> is important to read them. they list possible abnormal lab findings, list
> warnings, contraindications and information for patients.
> my new/first prescription of comtan came without package insert; i had to
> call and request it and return to pharmacy for it. for example, it lists
> hypotension as a possible occurrence--that matters to me because i already
> have hypotension thanks to sinemet. just curious how you all feel about them
> (p.i.)