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UK Only >>> Yellow Card Scheme

I discovered from a patient medication leaflet that there is a scheme for reporting side-effects from drugs.

I have reported Accord imatinib using the scheme. I believe that the patient is promised a response.

 

https://yellowcard.mhra.gov.uk

Hi Stephen,

With regard to your posting I am curious as to whether the Accord generic imatinib is creating a different side effect profile for you  from other generics and different to the original branded Glivec.

The issue of generic imatinib is an old chestnut and probably I would be howled down by the experts in pharma kinetics who would argue that there is no real difference in composition.The CML Society of Canada dealt with this issue some time ago and campaigned on behalf of patients who appeared to experience different intensity of side effects on generics as compared with original branded Glivec.

In its attempt to deal with the patent issue for Glivec in India a few years ago Novartis adopted an updated crystalline form -one was alpha the other beta and the generics still use the old formulation I believe.

My specialist advised me that if I had to go on to a generic that I should only use the Sandoz one (effectively a Novartis product)-I am on UK insurance and up until now have been on the original branded Glivec.My insurers told me that if I take a generic and if I experience a different side effect profile  then I must go back on to the original branded Glivec despite any cost differential.

For some medical conditions there appears to be a necessity to stick to the branded drug as opposed to using a generic-my partners neurologist stated that for epilepsy that the generics are far inferior to the branded original and are to be avoided.

Another view is that if you find a generic that you are happy with stick with it and dont keep chopping and changing manufacturer-that is if one has any choice in the matter.

With best wishes

John

Hello John. Thank you for replying.

This is a difficult subject. Some clinicians argue that the generics are absolutely equivalent but from the various forums I can see that patients are claiming that they are experiencing varying side-effects from one generic to another.

I was sceptical myself about the differences when I was issued with the Accord version of imatinib and started to suffer from a severe increase in bowel frequency and urgency. Previously, I had taken Sandoz (which maybe identical to Gleevec) and Cipla neither of which caused undue upset. 

I had sufficient stock of Cipla and Accord to juggle between the two generics, e.g. one or two weeks on one then two weeks on another. I concluded to my own satisfaction but there most definitely was a difference. I have a few Accord tablets left and I take one occasionally. Within 30 minutes of taking the Accord, I am rushing to the toilet.

I discussed this with my consultant who readily accepted my argument and prescribed Loperamide. However, I was told that it was a pharmaceutical matter rather than haematological matter. The pharmacist was also receptive to my argument, and even stated that other patients have noted similar issues. I was prescribed with Cipla.

Of course, in the UK we are lucky in that we do not have to pay for drugs when using the National Health Service, however, the patient is not in the position in the circumstances to dictate which generic is supplied in view of necessary cost saving measures.

It will be interesting to see whether I receive a helpful response as a result of the Yellow Card reporting.

I received today a prompt and long response from the MHRA.

They asked me for more information but did explain why different generics may cause varying side-effects. I did not learn much from this first response but it was pleasing but they are far from dismissive.

Anyway, it is a letter that I can take to the pharmacist when next time round when I have to plead not to be supplied with Accord.