Simvastatin is taken by around three million people in order to lower their cholesterol and reduce the risk of having a heart attack.
However an analysis of clinical trial data in America has found that high doses can cause muscle damage and a rare condition which induces kidney problems and may be fatal.
Patients were told not to stop taking simvastatin but advised to talk to their doctor if they have concerns.
The American medicines regulator, the Food and Drug Administration, has issued a warning to patients to be alert to signs of problems when taking the 80mg daily dose of simvastatin. It has also listed drugs that should not be prescribed to those on high doses of statins.'
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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
ReplyDeletehttp://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051756.htm
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 http://healthjournalclub.blogspot.com/2009/10/do-people-with-high-cholesterol-live.html 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. http://healthjournalclub.blogspot.com/2009/11/statins-and-global-transient-amnesia.html
Wonder if this new FDA advisory will change prescribing patterns? Or will the Zocor indication just be expanded to healthy people with normal cholesterol?