Drug Truths

A site devoted to teaching about drug discovery and development.

Being Overwhelmed By Safety Data on Drug Labels

with 2 comments

When you pick up a prescription drug, you’ll find it includes the drug label.  Among other things, this label contains safety information in the form of a warning label which describes the potential side effects that this drug might cause.  Obviously, this is a good thing.  After all, a patient should know the potential downside of taking any medicine.  However, as Gina Kolata pointed out in her article in The New York Times last Sunday (“Side Effects? These Drugs Have a Few”), warning labels keep growing longer with the AVERAGE label now listing SEVENTY possible adverse reactions.  When such a label gets this long, it becomes numbing and chances are patients will disregard it, thereby defeating the purpose of having these warnings.

There’s a seemingly easy fix to this problem.  Why not simply list only the major side effects and eliminate the lesser ones that might only occur in 1 out of 10,000 patients?  This unfortunately is not easily done.  The problem is that no drug is 100% safe.  It is impossible to design a medicine that will work identically in men or women, young or old, or in racially diverse groups.  Drugs behave differently even in highly homologous populations.  Thus, every drug will have a problem in a certain percentage of people who take it.  The FDA always weighs these risks before approving a new medicine, carefully measuring the risk-benefit of each new drug.

But let’s say that the FDA heeds the advice of Ms. Kolata and others and cuts back warning labels to just those of major or serious consequence.  Initially, this may be applauded.  However, the following scenario is likely.  A patient on a recently approved drug will have a rare, but serious, adverse reaction and will be outraged that the FDA didn’t warn him about this possibility.  A Senator or Congressman will then go on CNN and be irate that the FDA is exposing his constituents to such dangers.  Many will rail against the company that made this drug, saying it clearly only cares about profits and not the safety of sick people who are seeking relief from disease but instead subjects them to dangerous and expensive new products.  This will then lead to a major lawsuit where the injured party will seek millions in damages.

This scenario isn’t an exaggeration.  Even with the current onerous warning labels, these situations arise.  One may find the listing of a drug’s side effects in industry commercials to be ludicrous; however, how does the FDA and the drug manufacturer best prepare the prescribing doctor and patient for any potential consequence in taking this medication?  The FDA and pharmaceutical companies need to have extensive warning labels to show that rigorous efforts are being made to understand the benefits and risks that any medicine possesses.  True, they are no doubt protecting themselves from attacks by those who purport to be “protectors” of unsuspecting patients.  However, these labels represent a good-faith effort for complete transparency for the risk-benefit profile of a new drug.  More is known about newly-approved drugs now than at any other time in medical history.  This knowledge, however, leads to larger warning labels.

Perhaps the solution lies in having a revised warning label system.  One can envision having a set of “serious” warnings, ones that highlight major potential side effects that a patient could experience.  Presumably, this would be a limited and focused list (otherwise, why would the FDA approve the drug?).  Then there can be a supplementary list of side effects that would include things like headache, nausea, constipation, etc., things that seem to be listed in EVERY warning label.  Such a system could focus the doctor and patient on the potential side effects that they would really need to be aware of.


Written by johnlamattina

June 8, 2011 at 2:00 pm

Posted in Uncategorized

2 Responses

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  1. So it’s really a question of graphical design and layout. Reduce the font of the warning every time you go to a new category of risk (from 1 in 100 to 1 in 1000 for instance) and highlight life-threatening side effects in bold.

    Typo alert: “Drugs behave differently even in highly homologous populations.” You mean homogeneous populations, don’t you?


    July 5, 2011 at 6:45 am

    • Your solution is a reasonable one and could be a big improvement over the current situation. But would the FDA adopt it?


      July 5, 2011 at 12:31 pm

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