FDA Alert: Hydroxycut Linked to one death, liver damage and other health problems
Tuesday, May 1, 2009
U.S. health officials are warning consumers to stay away from Hydroxycut dietary supplement products marketed under the Iovate and MuscleTech brand names because of reports of liver problems resulting in at least one death -- an otherwise healthy 19-year-old male.
The manufacturer of the products, sold as fat burners and energy-boosters, is voluntarily recalling 14 products from the market.
"Consumers are advised to discontinue use of Hydroxycut products and consult a physician or health care professional if they are experiencing any symptoms of liver injury, which can include jaundice and brown urine, nausea, vomiting as well as unusual tiredness, unexplained itching and loss of appetite," said Dr. Linda Katz, interim chief medical officer at the Center for Food Safety and Applied Nutrition (CFSAN), part of the U.S. Food and Drug Administration (FDA), at a Friday news conference.
"Although liver damage appears to be rare, FDA feels consumers should not be exposed to unnecessary risk," Katz added.
The agency has received 23 reports of adverse liver effects including jaundice and liver damage severe enough to require organ transplant. Other individuals have experienced seizures, cardiovascular and other health problems. The medical literature also contains reports of liver issues in six patients taking Hydroxycut products.
Authorities do not yet know which ingredients are specifically associated with the problems.
The products being recalled are:
HYDROXYCUT RAPID RELEASE REGULAR CAPLETS
631656893649 Hydroxycut 140ct Cap
631656833621 Hydroxycut 60 GNC
631656600988 Hydroxycut 300ct Caplets
631656890129 Hydroxycut 36ct Cap US "with CARDS"
631656282245 Hydroxycut 160ct Cap US *Discontinued*
631656873214 Hydroxycut 58ct Cap
631656813418 Hydroxycut 70ct Cap
631656808612 Hydroxycut 70ct Caps US *Discontinued*
631656808117 Hydroxycut 100 cap US *Discontinued*
631656818642 Hydroxycut 140ct Cap US *Discontinued*
631656882414 Hydroxycut 80ct Caps US *Discontinued*
631656843262 Hydroxycut 210ct Cap
631656828665 Hydroxycut 210 cap US *Discontinued*
631656600582 Hydroxycut 60ct + 1 Hydroxycut Sachet WB
631656600476 Hydroxycut 72ct + Hydroxycut Sachet WB
631656600483 Hydroxycut 100ct Caplets
631656600506 Hydroxycut 150ct Caplets
631656601251 Hydroxycut 170 Caplets
631656600452 Hydroxycut 30ct Caplets
HYDROXYCUT HARDCORE LIQUID CAPSULES
631656600650 Hydroxycut Hardcore 120ct
631656600834 Hydroxycut Hardcore 210ct
631656001778 Hydroxycut Hardcore 30ct
631656601435 Hydroxycut Hardcore 252ct
631656601848 Hydroxycut Hardcore 30ct US Trial - Bodybuilding.com
631656601749 Hydroxycut Hardcore 120ct US NEW
631656601763 Hydroxycut Hardcore 252ct
631656601756 Hydroxycut Hardcore 210ct US NEW
HYDROXYCUT CAFFEINE-FREE CAPLETS
631656801224 Hydroxycut Caffeine Free 140ct Cap
631656821246 Hydroxycut Caffeine Free 330ct Cap
631656801217 Hydroxycut Caffeine Free 100ct Cap
631656801231 Hydroxycut Caffeine Free 58ct Cap
631656899122 Hydroxycut Caffeine Free 36ct Cap
631656600544 Hydroxycut Caffeine Free 60ct
631656600551 Hydroxycut Caffeine Free 72ct
631656600568 Hydroxycut Caffeine Free 100ct
HYDROXYCUT MAX CAPLETS
631656601466 Hydroxycut Max 120ct bonus + 1Hyd Max Sachet WB
631656601633 Hydroxycut Max 210ct Bonus + 1 Hyd Max Sachet WB
HYDROXYCUT REGULAR DRINK PACKET
631656860191 Hydroxycut Weight Loss Drink Mix 21pk Sachet - Wild Berry
631656860313 Hydroxycut Weight Loss Drink Mix 21pk Sachet - Country Lemonade
HYDROXYCUT HARDCORE DRINK PACKET (IGNITION STIX)
631656701326 Hydroxycut Hardcore Drink Mix 2.7g Sachet - Blue Raspberry
631656701319 Hydroxycut Hardcore Drink Mix 2.6g Sachet - Fruit Punch
631656760118 Hydroxycut Hardcore Drink Mix 40pk x 2g Sachet - Fruit Punch
631656760125 Hydroxycut Hardcore Drink Mix 40pk x 2g Sachet - Blue Raspberry
HYDROXYCUT CAFFEINE-FREE DRINK PACKET
631656760095 Hydroxycut Caffeine Free Drink Mix 21pk x 3.6g Sachet - Raspberry Ice
HYDROXYCUT MAX DRINK PACKET
631656860375 Hydroxycut Max Drink Mix 40pk x 2.4g Sachet - Wild Berry
631656860382 Hydroxycut Max Drink Mix 40pk x 2.7g Sachet - Lemonade
HYDROXYCUT LIQUID SHOT
631656800159 Hydroxycut Weight Loss Single Shot 2oz - Wild Berry
631656860207 Hydroxycut Weight Loss Shot 2 x 2oz Pk - Wild Berry
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry
HYDROXYCUT MAX AQUA SHED
631656601855 Hydroxycut Max Aqua Shed 60ct Capsules
HYDROXYCUT HARDCORE RTD
631656860436 Hydroxycut Hardcore 4 x8oz RTD - Grape Infusion
631656860399 Hydroxycut Hardcore 4 x 8oz RTD - Triple WildBerry
631656860665 Hydroxycut Hardcore 12-pack RTD - Grape Infusion
631656860467 Hydroxycut Hardcore 3 x 4-pack RTD - Grape Infusion
631656860443 Hydroxycut Hardcore 3 x 4-pack RTD - Triple Wildberry
631656860443 Hydroxycut Hardcore 3 x 4-pack RTD - Triple Wildberry
631656860568 Hydroxycut Hardcore 12-pack RTD - Triple Wildberry
HYDROXYCUT 24
631656600933 Hydroxycut 24 (96 caps/ blister pack)
HYDROXYCUT CARB CONTROL
631656800036 Hydroxycut Carb Control 58ct Cap
631656800029 Hydroxycut Carb Control 100ct Cap
631656800012 Hydroxycut Carb Control 140ct Cap
HYDROXYCUT NATURAL
631656600889 Hydroxycut Natural 100ct
Please note that Hydroxycut Hoodia and Hydroxycut Cleanse products are not included in this recall; nor are any other Iovate products.
Iovate Health Sciences of Oakville, Ontario, Canada has agreed to recall all the products. The company reports that more than 9 million units of Hydroxycut products were sold in 2008 in health food stores, grocery stores and pharmacies. "They are widespread," said Vasilios Frankos, division director of the Office of Dietary Supplement Programs, CFSAN, FDA. Hydroxycut Cleanse and Hoodia products are not being recalled as they have no overlapping ingredients with the 14 other products.
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