European Union Announces New Statin Warnings


In its monthly report released 27 November 2009, the European Medicines Agency's Pharmacovigilance group formally added several new adverse reactions to the statin drug warning list stating that there was no robust evidence for discriminating between the individual statin drugs in this regard.

As you may recall I long have reported no significant reason to discriminate one statin from another in terms of their side effect profiles. Since the statins are all reductase inhibitors, designed to inhibit the single reductase step in the complex biochemical pathway to cholesterol synthesis, one naturally would expect little difference in side effect profile regardless of which drug company's brand was involved.

Of particular concern to the European watchdog agency were reports of sleep disturbances, memory loss, depression and interstitial lung disease.

Sleep disturbances were frequently associated with bizarre nightmares, the nature of which caused the subject to fear sleep, resulting in sleeplessness. Frequently these were associated with depression unresponsive to the usual antidepressant medication.

Memory loss was frequently associated with amnesias of the transient global type but could occur separately.
Sexual dysfunction often occurred with depression but just as often occurred with no emotional overlay.

I have reported on all of these side effects but have not specifically mentioned interstitial lung disease. More recently, in my growing focus on tissue cell degeneration associated with mitochondrial mutations, the omission of mentioning lung disease was an oversight, for lung tissue, like any other organ tissue, heart, brain, muscle or nerve, can be involved in the process of oxidative damage to both mitochondrial and nuclear DNA.

The fundamental defect is mevalonate blockade by statins contributing to a relative deficiency of both CoQ10 and dolichols. This is an inevitable reaction with any of the so-called reductase inhibitors.

Reduced synthesis of cholesterol by this mechanism must be associated with reduced synthesis of CoQ10. The result of CoQ10 inhibition in pulmonary mitochondria is to allow excess oxidative damage to the surrounding tissue, protein, lipids and DNA. The cumulative effect of this is cell and tissue damage and death.

Interstitual lung disease involves the peri-alveolar structure with resulting fibrosis and diminished function. The primary symptom is shortness of breath.

To think that this type of formal warning is coming over 15 years after the marketing of statins first began. Finally we have an acceptance of statin causality for the thousands of reports of depression and sleep disturbance and cognitive disturbances.

In my repository this effect on cognition may well be the most common even without including the lesser forms of cognitive disturbance such as forgetfulness, disorientation and confusion. Nor does it include the inevitable short-term amnesia, measured in minutes rather than hours or the Alzheimer-like cases of dementia.
      
I must mention that the drug company drug warnings now being published for statin drugs are dramatically different from what they were 15 years ago.

Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor


Books From Amazon

The Dark Side of Statins
The Statin Damage Crisis
Cholesterol is Not the Culprit
Statin Drugs Side Effects
Lipitor, Thief of Memory


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