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Generic Imatinib side effects (WOCKHARDT BIO AG)


Hi all

I hope you are keeping well.

My question is has anybody else had a side effect to the generic imatinib?

I was put onto WOCKHARDT BIO AG imatinib 400mg and after 15 tablets was unable to walk I ended up un a wheel chair for 40 weeks and was in immense pain if on a scale of 1 to 10 I hit my 10.

I have other conditions but they seem unlikely to be the issue. My Hematologist has continued to try and fob me off, by saying it was arthritis and cannot be associated to the new drug as its the same, or that I may have had an allergic reaction to the excipient by which the drug is suspended in. After having the reaction, I was immediately taken of the generic Imatinib for around 5 months. I went to see my Rheumatologist who gave me an injection of steroids which helped. I was then taken in for rituximab infusion (used for the treatment of Rheumatoid Arthritis) this had no effect thus ruling out an arthritic flare up. The symptoms I experienced was as if somebody had put plaster of Paris inside every joint inside my body. I virtually lost all movement and became dependent on carers and my family to exist. I was sent for physio and hydro therapy eventually after 10 months something inside my right knee broke away and movement has began to return my joint now feel as though they are full of grit and are still limited but gradually improving and still very painful. I continue to improve, am back on Glivec and doing well I take pregabalin to manage the pain diclofenac sodium to help control inflammation and steroids as I have now developed what feels like crystals inside my muscles suspected as Polymyalgia Rheumatica I take one tablet of prednisolone every 2 to three days to allow the muscles to work which is effective under the direction of my GP.

I would be interested to know of any body else who may have had an adverse reaction to the generic imatinib.

your in the CML club


Stuart, I was on the Wockhardt generic for two years, initially at 400mg, and then at  200mg at the start of working towards TFR. The only difference I found between them and the Glivec was that the generic coating tasted horrible, and I tried to avoid it touching my tongue. There was no change to my side effects (cramp, flatulence) on 400mg, but these totally disappeared at 200mg. If your PCR is consistently at a low level, it would be worth discussing dose reduction with your CML doctor. If dose reduction improves your condition it indicates that the generic has been the issue, and in UK the doctor should report this by the yellow card system which was described on here a few weeks ago. 

Hi Stuart

I actually did the clinical trials for Imatinib in 2001,as such I had to fill in a daily diary ,the o my really bad side effect I.had was severe muscle cramps in my legs and hands.I do know if people in the same trials that have had to be taken off it because of huge effects,cramps vision problems and stomach upsets.The good part thoughts that 18  years later my last 6 ABL years show molecular undetectable though I still have to have 3 monthly check ups.Good luck to you,keep the faith .

hi thanks for the reply. 

 I have been on Glivec Novartis imatinib since 2008 never had any issues other than the usual associated side effects i.e. Cramps fatigue and diarrhoea. All of which are manageable, however when they switched me onto the generic version that is when I had the reaction that left me in a wheel chair for 40 weeks. I have now regained some movement but still have issues . I am back on the original imatinib (Glivec) my Cml is doing well and back under control. My last Pcr/abl was at 0.001 so from a Cml perspective things are ok.

my question was to find out if others had experienced a side effect after using the generic version.


Hello,  Very interested reading this as I was on generic Imatinib for about 18 months before I realised the aches and pains in pelvis/legs might be because of these generic tablets.  Had been on Glivec for 16 years before this with very few problems (started on compassionate trial 2001 as Interferon was not suiting me).  I built up a stock of Glivec before being switched to generics - tried all brands - I really wanted to give them a try.  When I went abroad last autumn I took a pack of Glivec tablets rather than the generic ones and just couldn't believe the difference!  I have since spoken to my consultant and pharmacist and requested that I only have the Sandoz ones (which is the Novartis generic) in future and they are quite willing to oblige.

There is a view floating around that there is no difference between branded and generic imatinib, i.e. they are medically identical in all respects. I think that few would challenge that the imatinib ingredient is identical across all drugs.

I received this as part of a long personalised letter from the MHRA in response to using their Yellow Card scheme. The investigation is not as yet complete:

You asked why Accord is different from other generic versions of imatinib. We wish to highlight that generic medicines, such as Accord imatinib are granted a licence following a study to demonstrate that the medicine is bioequivalent to the reference medicine (a medicine which already has an established license). Two medicines are bioequivalent when they produce similar levels of the active substance in the body (usually measured in the blood). The degree of difference allowed is defined by ‘European bioequivalence guidelines’ which state: small differences in blood levels can occur. Therefore, when comparing between two generic medicines, they will have shown bioequivalence to the reference medicine and therefore to each other. However, it may be worth highlighting that the production of the medicinal products and product excipients may differ slightly between generic products, however these differences should not impact the safety profile of the product. Therefore, although active substances are the same between generic medicines, the excipients which make up the medicine may vary and certain individuals may react to specific excipients within a medicine. You may find it useful to know that a full list of excipients in each medicine can be found in Section 6 of the PIL.

I can prove to myself, beyond reasonable doubt, that Accord imatinib does cause extreme bowel frequency and urgency. I would be sympathetic to others who suffer side-effects from specific generics. Fortunately, I have received good support from haematologists and pharmacists.