Drug Labels: Toxicity or Information Overload?

Posted by cdavenport on Saturday May 28, 2011 Under Drug Safety, Risk Management, toxicity

Side effect overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability.  Examination of more than 5600 drug labels yielded over half a million side effects.  An average drug label and the more commonly prescribed drugs averaged 70 and 100 side effects, respectively.  The upper range in a single label was 525 reactions.  Information overload can overwhelm physicians, who must weigh the risks and benefits when prescribing a medication.  The Food and Drug Administration discourages such ‘over warning,’ but information overload is presently the rule rather than the exception.  Not surprisingly, medications typically used by psychiatrists and neurologists had the most complex labels, while drugs used by dermatologists and ophthalmologists had the least.  Although providing drug safety information more efficiently to both health care providers and the public is warranted, drug manufacturer liability concerns must also be addressed.

Source: Drug Discovery and Development

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5 Responses to “Drug Labels: Toxicity or Information Overload?”

  1. Iyer Gopalkrishna Says:

    I agree. The greatest concern while compiling and listing of adverse effects has very little to do with Patient benefit or enhancement of Physician practice but to most effectively cover the backsides of the pharma company.

    Reality is “if there is no adverse effect, very likely there is no effect.”

    From a doctor’s perspective, if an adverse effect can be managed while treating the condition, it is never a problem – take the case of highly toxic oncology drugs.

    From the patients’ point of view, they have very little informed choice. Whatever information they might gather (and even the most persuasive and hard-nosed patient or relative will not get enough information he or she can understand fully) may not be enough to be confidently decisive about going ahead with the treatment. They usually rely and trust the doctors’ judgement.

    So, effectively, the physician and the pharma company being unwed, symbiotic partners, the long list(s) of toxic effects becomes purely a legal shield.

    When we are dealing with chemicals not native to the human body, intended to benefit the sick human body, this becomes a necessary legal safety net.

    No comments on whether it is good or evil. Till such time, someone comes up with a bettter system, let this continue.

  2. Mark Lawrence Says:

    My experience is in direct contrast to your assertion Cynthia. Having conducted several hundred readability tests for EU labelling, many patients feel that it is their rights as consumers to know what might happen as a result of taking a treatment. Also, the side effect section might explicitly prompt them to stop taking the medicine and alert their doctor if particular side effects show (e.g. severe allergic reactions). This is a key safety issue which may have been otherwise not addressed in the consulting room.

    The real issue from the point of view of ‘overload’, is not how many side effects you show, but how well they have been set out in the leaflet! The obligatory MEDRA frequency table baffles many non-scientists. The division into very common, common, rare, and very rare is valid and useful though. Theo Rayner has written papers on how best to communicate side effect risk to patients, striking the balance between being comprehensive and reassuring.

    Whether read by patients (in PILs) or doctors (in SPCs), a comprehensive list of side effects in frequency order is the best way of presenting risk and forewarning consumers. If this also mitigates the manufacturers liability, then so be it. Since 2006, EU manufacturers have to get through so many checks and hoops to get their prescribing information published, from the SPC approval to readability testing. It is absolutely fair that they should at least gain some benefit from the process, by reducing their exposure to risk.

  3. Michael Bowden Says:

    One of the problems is the insistence in some regulatory juriasdictions on adverse events rather than adverse drug reactions being listed in the prescribing information. Futhermore, there needs to be a distinction between those ADRs expected from the pharmacology of a drug and those that are more idiosyncratic. It is the latter that cause most of the problems. Finally, there remains precious little expert medical scrutiny of ICSRs resulting in complete claptrap appearing in labels for the sake of ‘process’. This isn’t good pharmacovigilance practice.

  4. Behzad Molavi Says:

    Your constructive and enlightening remarks made my day Mark. In my humble opinion formed throughout my years of operating in RA role, I have come to realize that including all possible side effects on the PIL, based on frequency of occurrence which you have rightfully advocated in the above, enables patients to follow their treatment regimen with further awareness, making health care practitioners more vigilant towards ADRs in return, and consequently fulfilling the cycle of pharmacovigilance and ADR reporting.

  5. Ivan Lafayette Says:

    Well, the topic itself answers the question per se. The thing is that we all know that the side effect overload is to create a void of responsibility just in case something goes wrong because most of the times those reported side effects are slightly ridiculous. They either happen once in a trillion times or are expected to happen but with no “substantial” biochemical/Statistical proof. I laugh out loud whenever I read on simple/common antidepressants leaflets secondary effects as “may induce suicide”. I know, I know, it is a serious matter and I take it very seriously, but that actually represents more a manufacturer liability rather than a true toxicity. What do you think?

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