Monday, March 22, 2010


On Friday, the FDA made an announcement, through their newsletter, entitled MedWatch, that high dose zocor may be associated with a risk of rhabdomyolysis. They re-analysed the results of the " Study of the Effectiveness of Additional Reduction in Choelesterol and Homocystineine ( SEARCH ) study" and also other data in their files. So this is retrospective. They compared 6031 patients on 80mg simvastatin to 6033 patients on 20mg simvastatin and found that those on 80mg ( high dose ) had a higher incidence of myopathy and rhabdomyolysis ( about 60x higher ) than those on 20mg. Granted that the overall numbers were small ( 63 cases Vs 2 cases ). Rhabdomyolysis can lead on toward acute renal failure and death.
When I read this, it raises three issues to me.
One pushing LDL-cholesterol super-low has a price. The risk of myopathy / rhabdomyolysis, compared to a marginal gain of lesser MACE. Secondly, high dose statins ( I dont think that this problem is confined to simvastatin. There were reports of myolysis and death in the earlier studies of rosuvastatin 40mg too ). Thirdly, and which probably the most important, being a responsible enforcement agency, the FDA regularly analyses their reports of adverse events, so that it does mean once approved, always good. Overtime, many new thinks can be learned and in the issue of drugs, it is adverse reactions.
Well with superstatins, and high dose statins, beware.


PDM said...

Of course the FDA recently expanded the indication of another drug in the same class, Crestor, to include people with normal cholesterol! It isn't like the FDA hadn't already issued a Public Health Advisory about Crestor and rhadomyolysis

Are we looking at another tragedy unfolding and yet another embarrassing about face by a compromised regulatory agency. Meanwhile the "lipid hypothesis" itself is being more and more widely questioned after decades of intensive lipid lowering have had no effect on heart disease rates. Perhaps even more astonishingly, when Dr. Uffe Ravnskov, MD PhD reviewed the medical literature he found something quite surprising had been documented there. On average, at least according to Dr. Ravnskov's review of the literature, people with higher cholesterol live longer. You can read on this here if interested.

There is also a write-up about Dr. Duane Graveline, MD and former NASA astronaut's findings concerning statins and the rare but serious side effect of global transient amnesia.

Wonder if this new FDA advisory will change prescribing patterns? Or will the Zocor indication just be expanded to healthy people with normal cholesterol?

About Just Me in T said...

Health Care is a misnomer.

As a prescription drug user you are nothing more than a means to another few dollars in the bank for the Big Pharmaceutical Giant and his Shareholders.

They knew ~

They failed to advise ~

They are responsible ~

For much pain and permanent damage done by their drugs ~

Side Effects are rare ~ Bah Humbug!