Posted by Cam W. on February 16, 2001, at 14:10:19
In reply to Reporting of adverse events -- Cam?, posted by Lin on February 16, 2001, at 12:33:46
Lin - The PDR (Physician's Desk Reference) and it's Canadian equivalent, the CPS (Compendium of Pharmaceuticals and Specialties) contain the drug company monographs of their drugs. They are reference books for professionals, so one needs to know how to read them properly.
I guess that the monographs in the PDR and CPS can be described as "lawyer's documents; written by lawyers, for lawyers". They are a good lesson in "Ass Covering 101". The side effects presented in monographs are all the adverse events that occurred to people taking the drug during clinical trials that were done in order to have the drug approved for use in the respective countries. As such, some of the lesser side effects (esp. those that occur 1 in 10,000) probably weren't due to the drug at all, but perhaps due to some extenuating circumstance in the clinical trial participant's life.
By law though, the drug company has to list all of the adverse events that occurred. Monographs are often updated to include new side effects (or changed percentages of current side effects) after drugs are released for use. The recording of these new side effects are usually those that are less common and occur under more realistic circumstances (naturalistic settings) than is seen in a clinical trial. The FDA in the U.S. and Health Canada in Canada have registries to which health professionals report suspected new side effects.
Therefore, the list of side effects (esp. the less common one; ie < 1 in 100,000) need to be taken with a grain of salt, but can be important under certain circumstances. Anything ingested or injected into the body can cause a side effect. Even a pebble, taken orally can cause an upset stomach.
Another interesting thing I have noticed is that Wellbutrin and Zyban (exactly the same drug - bupropion) have different side effects. The reason for this is the context in which the drug is taken. When taken as an antidepressant (Wellbutrin) bupropion will be perceived as having a different "feel" or different expected effect, than if it is being taken for smoking cessation (Zyban).
Hope this helps - Cam
poster:Cam W.
thread:54161
URL: http://www.dr-bob.org/babble/20010212/msgs/54169.html