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	The Pharmaceutical Journal Vol 269 No 7224 p711 16 November 2002	This page Reprint Photocopy
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Statins

OTC availability should not be endorsed yet

From an academic pharmacist

I read the news item on statins (PJ, 19 October, p558) with mixed feelings. I am pleased that the trials have shown the enormous benefits of the statins in reducing coronary artery disease, but I am not happy that the researchers seem to have ignored the substantial side effects of these compounds. I was particularly disappointed that Professor Peter Sever, one of the trial investigators, had suggested that statins should be available over the counter.

I come within the group of patients for whom these drugs are indicated. I had a silent myocardial infarction about four years ago and I have been taking the usual cocktail of medication for just over three years (beta blocker, angiotensin II inhibitor, aspirin, statin and diuretics). I took simvastatin for the first 30 months but complained of the side effects. I appear to have at least six (possibly seven) of the side effects described in Martindale.

At first my consultant thought these were due to the heart condition. However, I pointed out the list of side effects of statins in Martindale and in the British National formulary to my general practitioner. He took the matter a little more seriously and started doing three-monthly liver function, creatine kinase, cholesterol and triglyceride tests. LF and CK results were elevated and are still rising, although my cholesterol is down and the triglycerides are good. Six months ago my GP changed my statin to atorvastatin in the hope that the side effects might be a little less. However, only the dyspepsia seems to have diminished. Of the side effects, the rhabdomyolysis is by far the worst, causing muscle pains and weakness in my arms, shoulders and legs. It must be said that the three gastrointestinal symptoms are fairly unpleasant too but the effect on my liver could be serious, especially as I had an almost terminal dose of hepatitis A about 12 years ago.

My GP and the consultant have been discussing my treatment plan and after the most recent set of tests they have concluded that I should stop taking the statin, at least for a trial period, to see what happens to the side effects. Interestingly (from a professional point of view), I have not had many other side effects since I got used to the low blood pressure (around 90/50mmHg). However, I am not happy about having to stop the statin as I will now have increased risk of another MI as well as a greater risk of a cerebrovascular incident.

I appreciate that the benefits of statins are great for people who do not suffer the side effects that I have had to endure and that I may be an idiosyncratic patient. However, I would be disappointed to see these drugs transferred to the OTC market until there is a new generation available with less severe side effects. At the moment they should be left to GPs to prescribe.

I am an academic pharmacist currently, so I would be unlikely to be put in a difficult position regarding supply of the statins OTC. Nevertheless, I believe that the Royal Pharmaceutical Society should not endorse the provision of statins OTC until a new generation of pharmacists with much greater skills in prescribing and diagnosing side effects and statins with fewer side effects are available.

Name and address withheld
297/26

Professor PETER SEVER replies:

I note the comments made by your correspondent in response to your report of my suggestion that at some stage consideration will have to be given to statins being made available over the counter. THis would enable those who may ultimately benefit substantially from them, to have access to these drugs, which, I suspect, will not be the case despite changes in the guidelines.

I would prefer to delay a full commentary on this subject until after the definitive results of our trial are published in April next year in The Lancet. Then, I believe, will be the correct time to enter into a debate on this important issue. We hope, of course, to have had an opportunity to consider revised British and joint British guidelines by that time, and it would be on the basis of that information that the case for OTC statins could be further elaborated.

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