Guest guest Posted January 14, 2009 Report Share Posted January 14, 2009 Tomball Magnolia Potpourri - News FDA warns about tainted weight loss pills By Submitted article Published: 01.02.09 The United States Food and Drug Administration has alerted consumers nationwide Dec. 22 not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the US), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceed the FDA-recommended levels, putting consumers’ health at risk.These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements, according to the FDA. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Dr. Janet Woodcock, director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on the FDA’s inspection and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges, according to the Dec. 22 consumer alert.The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attacks or strokes. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the US. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last 2 years.Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.Online: www.fda.gov/medwatch/reportMail: use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms and mail to MedWatch, 5600 Fishers Ln., Rockville, MD 20852Fax: (800) FDA-0178Phone: (800) FDA-1088Information for consumers can be found at: www.fda.gov/cder/consumerinfo/weight_loss_productsTo learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide: www.fda.gov/cder/guidance/6911fnlThe tainted weight loss products are:Fatloss SlimmingJapan Lingzhi 24 Hours Diet7 Day Herbal Slim999 Fitness EssenceImelda Perfect SlimPerfect SlimProSlim PlusSlim Express 360SuperslimVenom Hyperdrive 3.02 Day Diet5x Imelda Perfect Slimming8 Factor DietExtrim PlusLida DaiDaihuaPerfect Slim 5xRoyal Slimming FormulaSlimtechTripleSlim3x Slimming Power3 Day Diet7 Diet Day/Night FormulaGMPMiaozi Slim CapsulesPhyto ShapeSlim 3 in 1SomotrimZhen de Shou «¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤Pray to God, do the right thing, and let Him worry about and take care of the details! Be AWARE, the terrorists are the government so there will be no surveillance of that group... I do not want to be a Global Citizen,I want to be a FREE AMERICAN. http://www.so-fab.com Due to budget cuts, the light at the end of the tunnel has been shut off until further notice..... MGMT In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. Quote Link to comment Share on other sites More sharing options...
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