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| 30 August 2011
UK Edition |
 Dear Reader,
Back on March 31, 2010, an American Food and Drug Administration (FDA) review had revealed that higher doses of the statin drug simvastatin (or Zocor) put patients at higher risk for devastating muscle injury and severe kidney damage, which could even lead to death.
Then, the FDA unsurprisingly issued a warning against "the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg."
Because that's what they do, right? Issue warnings. Warnings that probably don't even cover the worst of it — some people at the time were on 120 mg a day. What about them?
In addition to issuing their oh-so-comforting review, the FDA promised to continue to review the drug and that the public would be updated as soon as that review was completed.
Well, it's taken them a while (maybe the study report was really, really long), because in July this year they've FINALLY taken some real action. And that's after sitting on the initial study before issuing their 2010 warning — they've been reviewing this study for two years now.
The FDA has limited the 80 mg dose of Zocor, saying it should be avoided unless a patient has been taking that dose for 12 months or more and has not experienced any muscle problems. Which strikes me as odd, considering this would include people who started taking the drug AFTER the March 2010 warning was issued — I guess they dodged a major bullet there if they got out without any damage. (Risk for severe muscle damage is highest in the first year of treatment with statin drugs.)
The real kicker here is that 2010 ended up being a very big year for Zocor. It was prescribed 94 million times in 2010. That's twice the number of prescriptions in 2007. So much for that warning acting as...well, a warning.
There's been some talk about how the FDA is "stretched thin" and that safety reviews must be undertaken with care. But when people's lives are in the balance, I don't want to talk about an agency being "stretched thin."
While they sort out their issues of too few agents and too few resources (though those certainly aren't the only "issues" the FDA has), it's crucial that we explore other options. Safe, proven alternatives.
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Laying out lithium
Q: I have a question regarding the recommended dose of elemental lithium you recommend for daily use for those who wish to use it as a preventive measure. You recommend 10–20 milligrams of lithium aspartate or orotate. However, on the bottle of lithium orotate it states that each tablet contains 125 mg of lithium orotate, yielding 5 mg elemental lithium. Does this mean that in order to get the 10 milligrams needed one would need to take two tablets? The alternative would be cutting down the 125 mg tablet into twelfths... which doesn't seem probable. Thanks for your clarification.
Dr. Jonathan V. Wright: You're entirely correct! To obtain 10 to 20 milligrams of elemental lithium that research indicates can help keep your brain functioning at peak performance, you would need two to four tablets or capsules, each containing 5 milligrams of elemental lithium.
Lithium aspartate supplements containing 20 milligrams elemental lithium per capsule (manufactured by Bio-Tech Pharmacal) are also available at many specialist health food stores and online.
And even though I've never in 35 years seen anyone develop lithium toxicity from 20 milligrams of elemental lithium daily, it's wisest for anyone supplementing with lithium in any quantity to also take essential fatty acids every day. Essential fatty acids not only have many health benefits of their own but they're also a very effective treatment for lithium toxicity (in very large quantities, of course), and in small quantities will help prevent it.
Bear in mind we are not addressing anyone's personal situation and you should rely on this for informational purposes only. Please consult with your own doctor before acting on any recommendations contained herein.
Wishing you the best of health,
Andrew Miller
UK Editor
Nutrition and Healing
P.S. In the latest issue of Nutrition & Healing, Dr. Wright will explain how undiagnosed food allergies can contribute to poor health and reoccurring symptoms of almost any illness. Also learn about the 6 ways to identify a food sensitivity, the D-I-Y guide to allergy testing and how to treat food sensitivities... plus much, much more...
All new members who sign up will receive important updates like these in addition to receiving Dr. Wright's 7 Volume Library of Natural Healing.
Click here for full details.
Sources:
"FDA Limits High-Dose Zocor Over Muscle Damage," Pharmalot (pharmalot.com)
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