How Concerned Do We Need to Be About Drug Side Effects?

Doc Gumshoe looks at the fine print

By Michael Jorrin, "Doc Gumshoe", August 29, 2016

[ed note: Michael Jorrin is longtime medical writer who has been sharing his thoughts with our readers as “Doc Gumshoe” for several years (he’s not a doctor, I gave him the name).  He generally covers medical and health news and sometimes health promotions and hype, but he rarely opines about investments or specific stocks.  All of his past commentaries can be seen here]

Sometimes is seems as though the answer to most questions is “that depends.”   There are at least two ways that we can look at that question.   On the face of it, our concern should be based on the specific threat.  If the side effect is a mild headache or a short spell of stomach upset, but the drug knocks out a severe infection, no big deal.   But if the drug is meant to treat a relatively trivial disorder, and the side effect could be fatal, then it’s a very big deal indeed.

However, there’s another whole dimension to the consideration of side effects, and it is this: many people are dissuaded from taking a drug that could be highly beneficial in treating or preventing genuinely serious diseases or conditions, based on mostly exaggerated fears of side effects.   Fear of side effects, in turn, can be exaggerated in several ways.   Some side effects are exceedingly rare, but decidedly severe, and people don’t want to take that chance, even if it means forgoing the highly likely benefit they would experience from taking the drug.   Some drugs are associated with a long list of possible side effects, most of which are relatively innocuous, but the list itself intimidates persons who would likely benefit from taking the drug.   

What does the list of side effects really mean?

Here, to vex and confuse you, is the list of side effects in the official prescribing information (PI, also called “package insert”) for Lipitor (atorvastatin), which, as you probably know, has been one of the most-frequently prescribed drugs on Planet Earth.   I’m using Lipitor as an example of how to interpret the side effects listed in the PI, which are also the ones that are mentioned as possible side effects in the direct-to-consumer (DTC) advertisements and the material provided to patients along with the drug.   

lipitorpi

The side effects, also called “adverse reactions,” are listed in order of frequency at any dose, based on the results of the clinical trials submitted to the FDA for approval of the drug.