Warning: The medication may cause… anything

The Pediatric Insider

© 2013 Roy Benaroch, MD

Have you listened to the ending of a TV or radio ad for a new medication? “Side effects may include palpitations, chest pain, stoppage of the heart, sneezing, itchy scalp, limping, emotional upset, tiredness, wakefulness, getting an 80s song stuck in your head ….. do these lists ever end?

Regulations require that pharmaceutical ads and promotional materials include the information in the approved “Product Insert”, or “PI.” That’s the big sheet of tiny type, folded up into a little wad, that you’ll find in a new box of medicine from the pharmacy. It traditionally starts with a chemical description of the medication (just to be sure that no one reads any further), followed by a summary of research studies, and ending with dosing guidelines. In there somewhere will be paragraphs of information about any potential side effects—lists of any symptoms that occurred more often with the new drug than with placebo.

These lists end up so long that they’re almost useless. One study showed that new drug labels, on average, include 70 listed side effects—and some drugs included over 500. How could anyone, patient or doctor, slog through a list of 500 “potential” side effects to determine if any of them are relevant or worth worrying about?

The PI, like many other warning labels, seems to be more a tool to protect against lawsuits than a way to convey useful information. It’s like those food labels—“Made in a facility that also processes peanuts and shellfish and eggs.” What does that mean? People don’t get allergic reactions from eating food that was near something they’re allergic to. Just tell me what’s in the product, not what was in the building.

We need clear information about common, significant side effects and any early warning signs of rare but serious side effects that mean the drug should be stopped immediately. For almost any medicine I can think of, this list ought to be one short paragraph. A list of 500 side effects isn’t anything anyone will ever be able to use. Information overload is de rigueur, but it doesn’t help anyone avoid real risks.

Adapted from a WebMD post I wrote in 2011

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