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    Sunday, January 22, 2006

    Labels: The FDA is changing the labels on drugs. Isn't the label the sticker that goes on the outside of the drug bottle? The one with the instructions and the quantity and the patient name and pharmacist name and doctor name? What they're really changing is the package insert, that tissue-paper thin, fine-printed monograph that describes the detailed pharmacology of the drug. The one that doctors used to look up in the Physician's Desk Reference when they were looking for side effects and dosage instructions, but which has been supplanted by data bases like Epocrates for many physicians - because the electronic databases on handhelds are quicker, cheaper, and easier to use.

    The printed inserts are chock full of information - from the effect of the drug on fetal rats to dose-response curves, lethal dosage, and in some cases, antidotes to overdose. It's a great source for physicians, but not necessarily one that's all that useful for the average patient. So what's all the fuss about?

    Trial lawyers reacted angrily to a preamble to the new rule stating that the rule pre-empts, or supersedes, state liability statutes.

    In the preamble, the agency listed six claims against drug makers that would be prohibited as a result of the rule, including claims that a drug maker should have put into a label's "highlights" section a risk warning included elsewhere in its label, or claims that a drug maker should have included a warning that the drug agency deemed unnecessary.

    In other words, if one person out of thousands says that taking a drug made their eyes cross, then the drug maker doesn't have to include crossed eyes in its list of side effects. And evidently, if it doesn't have to include it, they can't be sued. (Although that's very doubtful. Anyone can sue anyone over anything.) And truthfully, those lists of potential side effects have become ridiculously long as drug makers seek to cover themselves legally. And that, in itself can cause problems:

    "Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health," the preamble states.

    That is certainly true. Take a look at this list of side effects for a common blood pressure drug. According to the package insert it causes everything from death to cold and flu. Who in their right mind would take it? Who would prescribe it. Well, most of us do prescribe it, and many patients take it. We just no longer take those kinds of side effect warnings seriously because they include every single possibile or reported ill effect rather than probable ill effects.

    Everyone would be better served by having realistic side effect listings rather than hypotheticals.

    posted by Sydney on 1/22/2006 06:44:00 PM 0 comments


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