Tag Archives: MHRA

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MHRA Drug Safety Update Summary
Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate. The risk appears to be mainly in patients already at increased risk of developing diabetes. However, the overall benefits of statins strongly outweigh any risks, including in those at risk of developing diabetes or those with pre-existing diabetes

The explanation for this is probably the fact that a 10% depletion in cell-membrane cholesterol will cause pancreatic beta cell to stop all insulin release

Xia F, Xie L, Mihic A, et al. Inhibition of cholesterol biosynthesis impairs insulin secretion and voltage-gated calcium channel function in pancreatic beta-cells. Endocrinology 2008; 149: 5136-45.

Statins: risk of hyperglycaemia and diabetes

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MHRA Drug Safety Update Summary

In August 2012 we published advice that simvastatin is now contraindicated with concomitant use of certain medicines, such as ciclosporin, danazol, and gemfibrozil. In addition, the recommendations for the maximum dose of simvastatin have changed when used with a number of other medicines, including amlodipine and diltiazem. These changes were driven primarily by concerns about an increased risk of myopathy and/or rhabdomyolysis at higher plasma concentrations of simvastatin, which may result from such drug interactions.

Following further consideration by the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines, this article summarises the evidence underlying the new advice that the maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day. The prescribed doses of amlodipine and diltiazem need not be changed.

MHRA Drug Safety Update – Statin

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Myopathy is a known side effect of all statins, including simvastatin, and the risk increases with higher doses. However, its most serious form, rhabdomyolysis, is a very rare side effect. The risk of myopathy is greater in: elderly patients (>65 years); women; patients with renal impairment or hypothyroidism; patients who consume large quantities of alcohol; those with a history of previous muscle problems during treatment with statins or other lipid-lowering drugs; or those with family history of muscle disorders. Concomitant use of some medicines may also increase the risk of muscle damage.

Statins MHRA warning

UK GPs warned over muscle risk with Statin

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If only we could have all the data on ‘Statins’, I have good reasons to suspect that they will become the pharmaceutical industry’s ‘PPI & LIBOR scandal’. In his latest book ‘Bad Pharma’ Ben Goldacre exposes the ways in which the trials of drugs can be used to give us the headline good news whilst toxicity, adverse events and important data about ‘all cause mortality’ is well hidden. Even (especially) the Doctors aren’t told. This book is on my reading list now.  This links to the Guardian review by Luisa Dilner.

Bad Pharma by Ben Goldacre – book review