Get Consumer Updates by E-mail Consumer Updates RSS Feed“This year, I’m going to lose some weight.”If you find yourself making this common New Year’s resolution, know this: many so-called “miracle” weight loss supplements and foods (including teas and coffees) don’t live up to their claims. Worse, they can cause serious harm, say FDA regulators. The agency has found hundreds of products that are marketed as dietary supplements but actually contain hidden active ingredients (components that make a medicine effective against a specific illness) contained in prescription drugs, unsafe ingredients that were in drugs that have been removed from the market, or compounds that have not been adequately studied in humans.“When the product contains a drug or other ingredient which is not listed as an ingredient we become especially concerned about the safety of the product,” says James P. Smith, M.D., an acting deputy director in FDA’s Office of Drug Evaluation.For example, FDA has found weight-loss products tainted with the prescription drug ingredient sibutramine.

This ingredient was in an FDA-approved drug called Meridia, which was removed from the market in October 2010 because it caused heart problems and strokes.“48 Bath Vanity With TopWe’ve also found weight-loss products marketed as supplements that contain dangerous concoctions of hidden ingredients including active ingredients contained in approved seizure medications, blood pressure medications, and antidepressants,” says Jason Humbert, a senior regulatory manager at FDA. Moving To Alaska AloneMost recently, FDA has found a number of products marketed as dietary supplements containing fluoxetine, the active ingredient found in Prozac, a prescription drug marketed for the treatment of depression and other conditions. Free Dogs For Sale In Quad Cities

Another product contained triamterene, a powerful diuretic (sometimes known as “water pills”) that can have serious side-effects and should only be used under the supervision of a health care professional.Many of these tainted products are imported, sold online, and heavily promoted on social media sites. Some can also be found on store shelves.And if you’re about to take what you think of as “natural” dietary supplements, such as bee pollen or Garcinia cambogia, you should be aware that FDA has found some of these products also contain hidden active ingredients contained in prescription drugs.“The only natural way to lose weight is to burn more calories than you take in,” says James P. Smith, M.D. That means a combination of healthful eating and physical activity.Under the Federal Food, Drug and Cosmetics Act (as amended by the Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims made about such products are true.

But just because you see a supplement product on a store shelf does not mean it is safe, Humbert says. FDA has received numerous reports of harm associated with the use of weight loss products, including increased blood pressure, heart palpitations (a pounding or racing heart), stroke, seizure and death. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have these products removed from the market.FDA has issued over 30 public notifications and recalled 7 tainted weight loss products in 2014. The agency also has issued warning letters, seized products, and criminally prosecuted people responsible for marketing these illegal diet products. In addition, FDA maintains an online list of tainted weight-loss products.To help people with long-term weight management, FDA has approved prescription drugs such as Belviq, Qysmia, and Contrave, but these products are intended for people at least 18 years of age who:Moreover, if you are going to embark on any type of weight control campaign, you should talk to your health care professional about it first, Smith says.

Look for potential warning signs of tainted products, such as:Generally, if you are using or considering using any product marketed as a dietary supplement, FDA suggests that you:If you suspect a product marketed as a dietary supplement sold online may be tainted, FDA urges you to report that information online. You or your health care professional can also report an illness or injury you believe to be related to the use of a dietary supplement by calling 1-800-FDA-1088 or visiting FDA online.This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products. Don't Be Fooled By Health Fraud Scams Mixing Medications and Dietary Supplements Can Endanger Your Health Some Bee Pollen Weight Loss Products Are a Dangerous Scam 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams "Lose it Overnight!" - FDA YouTube Video Tainted Weight Loss Products Health Fraud Scams - Weight Loss Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products

YOU ARE HERE: LAT HomeCollectionsHealth Hazards Two controversial diet drugs were removed from the market Monday after new evidence linked them to potentially serious heart valve problems, effectively ending the commonly known fen-phen combination that had been popular among those seeking to shed pounds.The Food and Drug Administration requested the withdrawal of the drugs fenfluramine, sold as Pondimin, and dexfenfluramine, sold as Redux. Wyeth-Ayerst Laboratories, the manufacturer of Pondimin and the distributor of Redux, agreed to recall the drugs immediately.The FDA said those using the prescription drugs should stop doing so immediately. The agency's action also prompted the French company that sells fenfluramine and dexfenfluramine abroad to withdraw the drugs worldwide.The FDA will not seek to remove another drug, phentermine, which with fenfluramine formed the fen-phen combination, because it has not been linked to the heart problems. All three drugs suppress the appetite.A spokesman for Wyeth-Ayerst, a subsidiary of American Home Products Corp. of Madison, N.J., said 2 million Americans have taken Redux--a product of Interneuron Pharmaceuticals--since it entered the market in June 1996, and 4 million have taken Pondimin since 1973, most in recent years.

Doctors recently began prescribing dexfenfluramine instead of the combination.Despite the continued availability of phentermine, experts do not expect it to be combined with another drug any time soon, given the problems that cropped up with fen-phen.Those problems first surfaced earlier this summer with the discovery of the heart valve abnormalities among patients taking the fen-phen combination, a use that was unsanctioned by the FDA. Subsequent investigation showed that only fenfluramine and dexfenfluramine appeared to cause the medical condition, the FDA said.Last week, the FDA analyzed heart tests on 291 patients using the drugs and found almost a third--92 people--had damaged heart valves, even though many had no symptoms. "These findings call for prompt action," said Dr. Michael A. Friedman, acting FDA commissioner. He added that fenfluramine and dexfenfluramine "present an unacceptable risk."Each drug had been approved by the FDA for single, short-term use for weight loss. But in the early 1990s an estimated 1 million Americans began taking the fen-phen combination after studies suggested that combined use of fenfluramine and phentermine over an extended period of time would result in significant weight loss.

These study results were never reviewed by the FDA, but agency officials believe that the increased magnitude and duration of use led to the heart valve problems.Once a drug is approved for marketing, doctors are allowed to prescribe "off-label" uses that may include using it in combination with another authorized drug.The heart has four major valves that regulate the flow of blood through the heart and to the lungs and general circulation. Valve disease can involve either excessive tightness, or leakiness; in the case of the two diet drugs, the problem was leakiness, which can result in the backflow of blood.*If this is severe, the heart has to work harder, causing heart dysfunction. Patients can experience shortness of breath, fatigue, chest pain, fainting and swelling of the legs. Also, patients can be asymptomatic, as many were in this case.Monday's developments came at a time when the pharmaceutical and medical device industries have been pressuring the FDA to move more quickly in approving new drugs and devices for the marketplace.

Later this week, the Senate is expected to approve legislation aimed at streamlining the FDA's operations.Even with scrupulous clinical trials, the dangers of new products sometimes are not fully known until they are in widespread use. Such was the case with the two diet drugs--clinical research did not detect the heart valve problems prior to approval, the FDA said. Typically, drugs do not cause heart valve abnormalities, so there was no reason to screen for them.Weight-loss experts said that the loss of the two drugs would narrow the options available to patients, but was not expected to have a damaging impact on most medically managed programs.Experts said they typically emphasize dietary changes and exercise as the most effective approach before turning to appetite-suppressing drugs. Drugs are usually used when other options fail, and for the seriously obese."We don't use medications as a first resort," said Dr. Arthur Frank, medical director of the George Washington University obesity management program.