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Pharmacy Services

Hydroxycut Consumer Warning and Product Recall

May 4, 2009

The FDA issued a warning for consumers to immediately discontinue use of all Hydroxycut products due to an association with severe liver injuries. Lovate, the manufacturer of Hydroxycut, recalled all products except Hydroxycut Cleanse and Hoodia in response to FDA's actions. Since 2002 FDA has received 23 reports of liver effects in Hydroxycut users including cases requiring liver transplant and one death due to liver failure. Hydroxycut products contain multiple ingredients in different proprietary blends; the causative ingredient in these events has not been identified. Ephedra was previously thought to be the cause, but it was removed from the product line in 2004, and additional cases were reported subsequent to its removal. Other serious problems reported by Hydroxycut users include kidney failure, rhabdomyolysis, irregular heart beat, and heart attack.

Consumers are advised to contact a health care provider if they have taken a Hydroxycut product and any of the following symptoms develop: jaundice, abdominal pain, fever, fatigue, weakness, itching, light colored stools, brown urine, or nausea. Healthcare providers are advised to review all cases of hepatitis for a possible relation to Hydroxycut, and report any correlations to FDA via the MedWatch program: http://www.fda.gov/Safety/MedWatch/default.htm

Hydroxycut products being recalled:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Natural
• Hydroxycut Max Liquid Caplets
• Hydroxycut Max Aqua Shed
• Hydroxycut Max Drink Packets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Carb Control
• Hydroxycut 24

Additional information is available at the following links:

• FDA News:
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149575.htm
• Dear Healthcare Professional Letter:
  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm155847.htm
• Health and Hazard Evaluation:
  http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM160672.pdf
• Hydroxycut Questions and Answers:
  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm155837.htm
• Hydroxycut Products Information Page:
  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm155600.htm

Updated
May 4, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.