Adverse drug effects; clinical trials and real life - What we can learn from Pradaxa

Adverse drug effects; clinical trials and real life -  What we can learn from Pradaxa

From the University of Sydney, Australia, Wendy Lipworth, Senior Research Fellow, Bioethics and Ian Kerridge, Associate Professor in Bioethics & Director, Centre for Values and Ethics and the Law in Medicine, provide insights into the challenges of identifying adverse drug effects both during trials and after a drug is approved, along with the difficulties of comparing the side effect risks of new and established drugs. The drug in question, Pradaxa, may also be of relevance to some in our community, as it is prescribed to people with abnormal heart rhythms and other diseases that cause blood clots.

"Even the best-designed clinical trials provide only preliminary information about adverse drug effects.

This is not ideal but it can’t be helped because clinical trials are, by necessity, artificial set-ups, tightly controlled in terms of patient selection, drug dosages, length of treatment, monitoring, and so on. They don’t, and can’t, reflect the vagaries and complexities of real-world prescribing practice and patient behaviour.

So it’s almost inevitable that at least some new adverse effects will emerge after a drug has been approved for marketing."

This is a longish read, but isn't all that technical. I'd highly recommend it to anyone anticipating going on a trial, in a trial, or starting on a newly approved drug. It certainly makes you even more appreciative of those that face the unknowns of new medications during trials and in the early days after approval...


Photo: Australian Golden Whistler

1 Reply

  • That quote should be required reading for patients beginning treatment with new drugs like Imbruvica (ibrutinib), Gazyva (obinutuzimab) and Zydelig (idelalisib) .

    Everyone is different, and adverse events do occur. Hopefully doctors are on the ball, but patients can also report problems to drug licensing most countries.

    In the UK it is called Yellow Card... like soccer... ya know... I have never been carded... :)

    In the USA ...Medwatch

    Canada MedEffect

    Australia TGA

    But I'm probably whistling in the wind... ;-) great photo... oh for a longer lens!

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