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Wednesday 18 March 2015

Rienso. Another Pharmaceutical drug withdrawn as it caused serious hypersensitivity reactions

Another pharmacetical drug, Rienzo (Ferumoxytol), has been quietly withdrawn from the market. Have you heard about it? No?

Well, the withdrawal was quietly announced in MIMS, which describes itself as "one of the most up-to-date prescribing references for healthcare professionals", in an email published on 18th March 2015, and on its website on 16th March 2015 where the event was described as follows:

          "The intravenous iron preparation Rienso (ferumoxytol) has been withdrawn for commercial reasons. Launched in 2012, it was licensed for the treatment of iron deficiency anaemia in patients with chronic kidney disease".

That's it! And we should perhaps note that the withdrawal was done "for commercial reasons". So nothing wrong with that, then.

Except, of course, the reason for the withdrawal was not quite as benign as that! 

In another MIMS article, published in September 2014, the reason for the 'withdrawal' for 'commercial reasons' may become a little clearer.

           "Takeda has issued a letter to healthcare professionals about the risk of serious hypersensitivity reactions associated with the use of its injectable colloidal iron-carbohydrate complex, ferumoxytol (Rienso)".

So the European Medicines Agency (EMA) and the British drug regulator, MHRA, provided restrictive prescribing information for Rienzo "to mitigate the risk of serious hypersensitive reactions". It was 'contraindicated in patients with any history of drug allergy". The drug had to be "administered by trained staff in an environment where resuscitation facilities are available", and patients receiving the drug were to be monitored for hypersensitivity reactions, "including blood pressure and pulse rate, during and for at least 30 minutes after completion of the infusion". And even after this, patients were to be advised to seek urgent medical attention if they start to feel unwell

Less than two years earlier, MIMS had heralded the new drug, and its safety and efficacy in clinical drug trials!

          "The safety and efficacy of intravenous ferumoxytol were assessed in three open-label studies involving 837 patients with CKD and iron-deficiency anaemia".

It proceeded to outline and reference the studies.  The article went on to describe how 'well tolerated' the drug was, as demonstrated by three further RCTs (Randomised Controlled Tests).

Clearly 'evidence-based medicine' at its very best!

Yet this is a common tale. The conventional medical establishment heralds a new drug as being safe and effective. Then it is discovered the drug is neither safe or effective. Then, if there is no profit to be made in marketing the drug, it is quietly withdrawn "for commercial reasons".

And as far as Rienso is concerned, this all happened all in less than 3 years.

Perhaps my skeptic friends, who spend their time upholding the value of RCTs, who demand this evidence for homeopathy and other alternative medical therapies, who champion the benefits of 'evidence-based-medicine' would like to comment on this post. I would be interested to hear their views on the value of drug testing and drug regulation, and the safety of marketing drugs like this for patients.

Unfortunately, I don't think they will have anything to say!