New statin AE update from UK

[David Staup]

"*http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON062553

download the pdf and go to page 11
or read below:

In February 2008, we reported a European-wide review on statins. New advice
and information on side effects have been agreed, and healthcare professionals
should be aware of the updated information so they can discuss it appropriately
with new and existing patients.
The headline message from the review was that the balance of risks and benefits
of statins as a class remains positive. Statins are one of the most important and
widely used medicines in patients with lipid disorders and in the prevention of
cardiovascular events. The efficacy and safety of statins have been studied in a
number of large trials for both primary and secondary prevention of cardiovascular
disease showing that overall, statins can reduce heart attacks and the need for
bypass surgery and similar types of operation, and even save lives for certain
patient groups. Trials have also shown that statins are generally well tolerated by
most people who use them.
However, the review also identified the need for the product information for all
statins to reflect the issues identified from analyses of clinical trial and postmarketing
data from case reports of adverse drug reactions. These included sleep
disturbance, memory loss, sexual disturbances, depression, and interstitial
pneumopathy. The review also considered published and unpublished data and
relevant clinical guidelines, and concluded that it was important that prescribers
and patients alike are aware of the potential for these adverse reactions.
• Patients should be made aware that treatment with any statin may be
associated with depression, sleep disturbances, memory loss and sexual
dysfunction
• Statins may very rarely be associated with interstitial lung disease. Patients
should seek help from their doctor if they develop presenting features of
interstitial lung disease such as dyspnoea, non-productive cough, and
deterioration in general health (eg, fatigue, weight loss, and fever)
On the basis of the data examined for individual statins and the class as a whole,
the review concluded that there is sufficient evidence to support a possible causal
relationship between statin use and the above adverse reactions. Summaries of
Product Characteristics and Patient Information Leaflets are being amended to
include the potential for these reactions.

[Biologist]

Nice find, David.

We're getting there. Slowly but surely. (But mainly slowly...)

Biologist

[Wisper]

[quote="Biologist"]Nice find, David. We're getting there. Slowly but surely. (But mainly slowly...) Biologist[/quote]


Hello Biologist, unfortunately I've found progress seems too slow.
I'm in the UK and I've been been taking statins for 4 years and had
truly APPALLING psychological and perhaps physical side effects and
didn't even realise what was causing them until this year!

Six months ago I worked out one of my "blood meds" was causing a problem
and more or less stopped all of them. Not very wise but when I did stop
I noticed my mind was very much clearer.

I thought the problem was one of the blood pressure meds and didn't even
suspect the statin! Very belatedly someone happened to post me a link in
a forum which mentioned psychological problems due to statins. That was
only TWO WEEKS ago! (30th Oct to be precise.)

I'm almost in shock because I live alone and don't integrate much with
my local community. So I had no friend to observe exactly what was
happening. The effects I've suffered have been terrible and changed my life
for the worse.

I need to get myself together (my backlog of unfinished tasks from recent
years is large) and then post my story to the right thread.

Oh my! Progress in understanding this really has been slow for me and it
has cost me dearly. It's so hard to explain (but maybe your experience let's
you understand) that I could not in any way have made this post when I was
getting side effects.

All this is such a shock to learn. It's hard to know which way to turn.

--
[i]Wisper[/i]

[Biologist]

You have found the right place, Wisper.

Like you, I never had the slightest clue that statins were causing me such problems -- until I was hit like a train three years ago. It makes me sick right now to think about it, and that I took them for so long. If I won the lottery today but had the chance to have never heard the word "statin" instead, I would be thoroughly healthy right now.

My world, including my world view, has been significantly altered.

We'll make the best of it though.

Good luck to you.

Biologist