食物警告：红曲米营养药丸含statin药物
Posted: 2007-08-09 13:57
今天收到FDA发布的警告，两家出产的红曲米dietary supplement内含statin类降胆固醇西药lovastatin成份，但是产品标签上未写。（他们也不能写，因为他们根本没有执照允许他们生产和卖lovastatin。）我去其中一家的网站看了一眼，标签上的有效成分写的只有：red rice yeast, gelatin。
这种＂补品＂是拿来当＂自然降脂药＂推销的，大概很多人买了吃了发现真的有效果，而且＂纯天然＂，以为安全，乐滋滋地继续花钱，不知道其实是吃了处方药。Statin类药有副作用的可能，包括（不常见）急性肌肉组织分解（rhabdomyolitis）和肾衰竭，和肝功能问题。怀孕妇女不建议用，有可能导致胎儿受损。
FDA没有讲这几个产品是哪里出产的，在网站上也没找到产地。
FDA没有权力审查管制dietary supplement上市，只能在此类产品上市销售后检验，如果发现对大众健康有害，才能禁止。我认识在FDA工作的朋友，知道他们根本没有时间资源和人力监督所有市场上的产品，大家自己慎用吧。尤其是草药中药天然补品什么的，有时候标签上写的成份实际没有或者过少过多，有时候标签上没写的成份倒有。象此类拿西药成份达到草药根本达不到的效果骗人，例子太多太多。Buy at your own risk.
这种＂补品＂是拿来当＂自然降脂药＂推销的，大概很多人买了吃了发现真的有效果，而且＂纯天然＂，以为安全，乐滋滋地继续花钱，不知道其实是吃了处方药。Statin类药有副作用的可能，包括（不常见）急性肌肉组织分解（rhabdomyolitis）和肾衰竭，和肝功能问题。怀孕妇女不建议用，有可能导致胎儿受损。
FDA没有讲这几个产品是哪里出产的，在网站上也没找到产地。
FDA没有权力审查管制dietary supplement上市，只能在此类产品上市销售后检验，如果发现对大众健康有害，才能禁止。我认识在FDA工作的朋友，知道他们根本没有时间资源和人力监督所有市场上的产品，大家自己慎用吧。尤其是草药中药天然补品什么的，有时候标签上写的成份实际没有或者过少过多，有时候标签上没写的成份倒有。象此类拿西药成份达到草药根本达不到的效果骗人，例子太多太多。Buy at your own risk.
FDA NEWS RELEASE
For Immediate Release: Thursday, August 9, 2007
Media Inquiries: Catherine McDermott, 301-827-6242, catherine.mcdermott@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol
Products found to contain unauthorized drug
The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.
The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.
“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.
These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.
FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.
The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA’s Web site: www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.
FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.
。