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Right then, kiddies, the pub beckons, and I can hardly decline, so I'm gone for the day. Have fun . . . 243 days ago
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Fake and/or toxic drugs, Part 2…

Posted May 28 2010 12:00am

As I said a few days ago, in Fake and/or toxic drugs… I had reported the problem to  the Medicines and Healthcare products Regulatory Agency (MHRA). They, in turn, passed it to their Defective Medicines Reporting Centre (DMRC).

Result – a brush-off. What’s needed is an investigation.

Dear Mr Graves,


We have received a copy of the email you sent to the Enforcement department of the MHRA who have referred it to us..

We have checked our database and the colours for these two products, which are both licensed, are correct. The side effects which you have experienced i.e. headache, diarrhoea and feeling sick are all listed as side effects on the Patient Information Leaflet. We can check whether the batches you have received are genuine by if you provide the batch numbers to us.

May we suggest that you discuss this with your G.P. if you continue to experience these problems. Thank you for your report.

Kind regards, (end)

.

Dear ……,

I’m pretty sure I made it quite clear that I don’t experience any side effects with PPIs, which I have been taking for quite a long time, mainly for the treatment of GERD, and for much of that time I took Omeprazole (though as they clearly can’t be trusted I have switched to Pantoprazole).

Side-effects, as I’m sure you know, are listed simply because they were experienced – often by a small number of people – during the trialling of the drug. It does not mean that every patient will experience them or, even, that any patient will. It just means that they have happened and might possibly happen again. The lists of side effects for many of my drugs are horrendous, but I am fully aware that they exist in potentia – there is no certainty that any of them will actually happen and, for the most part, they don’t.

I have no problems, ever – again, as I said – with Omeprazole from a variety of manufacturers, which tend to appear in the standard purple/grey capsule, only with the two batches with their unusual blue/orange livery.

Uncontrollable, running-down-my-legs diarrhoea – so bad that I dare not go out, or even get dressed, much of the time – is NOT an acceptable side-effect. Nor is it one I have ever experienced with PPIs before or since.

I never experience adverse side effects from PPIs (I know I keep reiterating this, but it’s important that you grasp the significance). That two batches of apparently identical PPIs, albeit from different sources, cause side-effects of such unwonted and intolerable severity indicates that they deviate from the norm in some way. The logic is inescapable. The batch numbers follow, but they won’t tell you if the capsules contain a drug of the wrong strength, or are contaminated in some way. Will they?

Relanchem batch number: PL 20395/0017

Laboratorios Davur batch number: D001

It seems likely, by the way, that these licence holders sourced their drug from the same suppliers – how else to account for identical problems from an apparently identical product? Problems totally at odds with normal Omeprazole.

Regards,

Ron Graves.

.

The only way to find out what’s wrong with these drugs is to submit them to analysis, to find out why the are toxic – the batch numbers won’t show that. It’s not a problem that talking to my GP will solve, other than changing to a different drug, which I’ve done. I now have Pantoprazole, which isn’t as effective as Omeprazole, so I’m not happy about that, either.

Any further correspondence will be posted here in due course.

53.387073 -3.022126
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