FDA warns consumers about Hydroxycut
ROCKVILLE, Md. The Food and Drug Administration on Friday warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences based on a possible association with a number of serious liver injuries.
Iovate has agreed to recall Hydroxycut products from the market.
“Iovate Health Sciences is strongly committed to product safety and welcomes balanced regulation for the dietary supplement industry,” the company stated Friday. “The number of adverse event reports described by the FDA in its advisory is small relative to the many millions of people who have used Hydroxycut products over the past seven years. Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the FDA. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients,” the company noted.
Steve Mister, president and CEO for the Council for Responsible Nutrition, stated that, “both the Food and Drug Administration, as well as the manufacturer of the Hydroxycut products in question, took appropriate action today. We commend FDA for warning consumers of a potential safety problem associated with these products, and were encouraged to see that the company — Iovate Health Sciences — agreed to recall the products from the market until further determinations can be made.”
Hydroxycut is the leading dietary supplement diet aid in food, drug and mass markets, generating $36.8 million in sales across food, drug and mass (minus Walmart) outlets for the 52 weeks ended Oct. 5, 2008, according to Information Resources Inc. data. According to FDA officials, Hydroxycut reported it had sold more than 9 million units in the calendar year of 2008.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk,” stated Linda Katz, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition. During a press conference with reporters Friday morning, the identification of the possible link between liver adverse events and Hydroxycut was made possible in part by the mandatory reporting of adverse events associated with dietary supplements.
The FDA has received 23 reports of serious health problems, ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The death occurred in the fall of 2007 and was reported to the agency in March, 2009, FDA stated. “[However], the 2007 death referenced by the FDA was not caused by Hydroxycut,” the company noted.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently 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 has not 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.
Convenient Care Association set to provide ‘first line of defense’ against illnesses
PHILADELPHIA The Convenient Care Association, the retail clinic industry’s member-based organization that has more than 1,200 member clinics in 30 states, has announced that its members are prepared to help patients in light of the spreading risk of the swine flu, as well as ongoing incidence of seasonal flu.
“Convenient Care clinics provide a first line of defense against illnesses such as the flu,” stated Tine Hansen-Turton, executive director of the CCA. “They are accessible and responsive to the public, and are equipped to contribute to the broader public health response around the country.”
Those nurse practitioners, physician assistants and physicians working within retail-based clinics are available to answer patients’ questions; provide diagnosis and treatment; write prescriptions for such anti-viral medications as Tamiflu and Relenza, as clinically necessary; and triage patients to other sources of care. At some clinic locations rapid testing for type A influenza is available.
Clinics are working with local health officials and receiving updates from the Centers for Disease Control and Prevention and World Health Organization. Clinicians adhere to CDC infection control precautions, including the use of surgical masks, gloves, and gowns, if appropriate, the CCA stated.
According to the CDC, the following recommendations may help prevent transmission of the flu virus: cover your nose and mouth with a tissue when coughing or sneezing, and then dispose of the tissue in the trash; wash your hands frequently using soap and water or using alcohol-based hand sanitizers; avoid contact with those who are sick and stay home from work or school if you think you might be sick; avoid touching your nose, mouth, or eyes.
The Natural Products Foundation promotes new program
WASHINGTON The Natural Products Foundation on Thursday sent out an e-mail blast encouraging donations to its new program, called Health Match, “that allows companies who manufacture vitamins, supplements, nutrition bars, personal care items and other natural products to directly contribute these goods to clinics and organizations that help AIDS victims, cancer patients, the malnourished and many others.”
“The current economic climate has been extremely difficult for many people,” wrote Tracy Taylor, NPF executive director. “All over the country, healthcare programs for the disadvantaged are experiencing an increase in patients needing services and a decrease in funding, creating a huge material disparity in these already stressed programs.”
The Healthy Match program will connect companies willing to donate products and the healthcare programs that need them, Taylor said.