FDA warns consumers to stop using Hydroxycut dietary supplements

Consumers using Hydroxycut products should immediately stop taking the dietary supplements, the Food and Drug Administration warned today after receiving reports of serious health problems related to the drugs. The dietary supplements -- made by Iovate Health Sciences Inc. of Oakville in Ontario, Canada, and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. -- have been linked to one death and are associated with several serious liver injuries, the FDA said. Iovate has agreed to recall the products from the market. The FDA has received 23 reports of serious health problems including jaundice, elevated liver enzymes and liver damage requiring liver transplant. Other health problems reported included seizures, cardiovascular disorders and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. One death due to liver failure has been reported to the agency. Liver injury was reported by patients taking the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice and brown urine, the FDA said. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite. “The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk," said Linda Katz, interim chief medical officer of the FDA's Center for Food Safety and Applied Nutrition. "Adverse events are rare, but exist. Consumers should consult a physician or other healthcare professional if they are experiencing symptoms possibly associated with these products." Hydroxycut products are dietary supplements that are marketed for weight loss as fat burners, energy enhancers, low-carb diet aids and water loss. The list of products being recalled by Iovate includes: Hydroxycut Regular Rapid Release Caplets Hydroxycut Caffeine-Free Rapid Release Caplets Hydroxycut Hardcore Liquid Caplets Hydroxycut Max Liquid Caplets Hydroxycut Regular Drink Packets Hydroxycut Caffeine-Free Drink Packets Hydroxycut Hardcore Drink Packets (Ignition Stix) Hydroxycut Max Drink Packets Hydroxycut Liquid Shots Hydroxycut Hardcore RTDs (Ready-to-Drink) Hydroxycut Max Aqua Shed Hydroxycut 24 Hydroxycut Carb Control Hydroxycut Natural Although the FDA hasn't received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and hoodia products are not affected by the recall. (Some hoodia sellers on Monday were sued by the Federal Trade Commission on charges of deceptive advertising for claiming that their produce would help people lose weight.) Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The products contain a variety of ingredients and herbal extracts. Healthcare professionals and consumers are encouraged to report serious side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting program: -- Online: www.fda.gov/MedWatch/report.htm -- Regular mail: Use FDA postage-paid Form 3500 found at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 -- Fax:( 800) FDA-0178 -- Phone: (800) FDA-1088 -- Andrea Chang Photo: The FDA has linked the use of Hydroxycut products to serious health

FDA says these products can put the DIE in ‘Diet’

It’s getting to be that time of the year, when weight-loss companies start making us worry about what we might look like in a bathing suit this summer. If you decide that you need to slim down, however, the U.S. Food and Drug Administration has this word of advice - be careful about taking pills, powders or potions that might contain prescription drugs and/or undeclared active pharmaceutical ingredients.

The FDA recently issued a second round of warnings about weight-loss products. This time the list has grown to 72 products - including Herbal Xenicol, Slimbionic, and Xsvelten - and is warning consumers about products containing fenproporex, fluoxetine, furosemide and cetilistat.

For the current list of products on the FDA’s list, click here

“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 maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health,” Woodcock said.

The products on the FDA’s list - some of which are marketed as dietary supplements - are promoted and sold on various Web sites, and in some retail stores and beauty salons.

Some of the products claim to be “natural,” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements.

Antidepressants, anti-seizure medication, experimental drugs

These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:

• sibutramine (an appetite suppressant available by prescription only and a controlled substance)

• fenproporex - a controlled substance not approved for marketing in the United States;

• fluoxetine - an antidepressant available by prescription only;

• bumetanide - a potent diuretic available by prescription only;

• furosemide - a potent diuretic available by prescription only;

• rimonabant - a drug not approved for marketing in the United States;

• cetilistat - an experimental obesity drug not approved for marketing in the United States;

• phenytoin - an anti-seizure medication available by prescription only; and

• phenolphthalein - a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

The FDA has inspected several companies associated with the sale of these products and is working on product recalls.

And if the companies are uncooperative, the FDA “may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.”

The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. (And perhaps check with your doctor in future, before taking any weight loss product.)

Seizures and sudden death

“The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke,” the FDA states in its warning.

“Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.”

If you experience a serious reaction to any of these products, the FDA asks that you or your doctor report this to the FDA’s MedWatch Adverse Event Reporting program, either online, by regular mail, FAX or phone.

If you mail your information, you can download the postage-paid FDA form 3500, available at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm and mail it to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Or FAX it to 1-800- FDA-0178.

Or you can call in your report at 1-800- FDA-1088.

For more information provided by the FDA on weight-loss products, click here

FDA Adds More Diet Pills to Its "Unsafe" List

The FDA adds 41 more products to an alert about unsafe diet pills it issued last month, bringing the total to 69.

The pills are advertised as "natural" fat busters and some suggest they are innovative "herbal" remedies from Asia.

But, the FDA says many contain Sibutramine, a powerful appetite suppressant that can cause heart attacks and strokes.

Reported by: Robin Thibault, KARK 4 NEWS

http://arkansasmatters.com/content/fulltext/news/?cid=173631

FDA Warning on 38 Diet Pills

The FDA warned consumers not to buy or use more than 25 products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may be risky.

Those products, which may be sold online or in stores as "dietary supplements," are:

Undeclared Drug	Product(s) Name
Sibutramine	2 Day Diet 3 Day Diet 3x Slimming Power 5x Imelda Perfect Slimming 7 Diet Day/Night Formula 7 Day Herbal Slim 8 Factor Diet 24 Hours Diet 999 Fitness Essence Extrim Plus Fatloss Slimming GMP Imelda Perfect Slim Lida DaiDaihua Miaozi Slim Capsules Perfect Slim Perfect Slim 5x ProSlim Plus Royal Slimming Formula Slim 3 in 1 Slim Express 360 Slim Tech Somotrim Superslim Triple Slim Venom Hyperdrive 3.0 Zhen de Shou
Rimonabant	Phyto Shape
Phenytoin (trace)	3x Slimming Power Extrim Plus
Phenolphthalein	8 Factor Diet 24 Hours Diet Fatloss Slimming Imelda Perfect Slim Perfect Slim 5x Royal Slimming Formula Superslim Zhen de Shou

resources: http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

"These products have not been approved by the FDA, are illegal, and may be potentially harmful to unsuspecting consumers," states an FDA news release.