BPL-G
Jak pewnie czesc osob slyszala rewelacje na temat Hydroxycut'a w stanach wyszla informacja o mozliwym uszkodzeniu watroby i jednym zgonie przez skladnik zawart w Hydroxycut'ie. Nie jest to info jeszcze pewne potwierdzone ale sadze ze powinno sie znalesc w tym dziale.
ze strony NY Times:
Hydroxycut Diet Aids Recalled After Warning
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By NATASHA SINGER
Published: May 1, 2009
Federal drug regulators warned consumers Friday to stop using the popular Hydroxycut line of weight-loss products, citing reports of a death due to liver failure and other instances of serious health problems.
In all, the Food and Drug Administration said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said.
The Hydroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the F.D.A.
That company, Iovate Health Sciences of Oakville, Ontario, and its American distributor are voluntarily recalling 14 of the products. Two other products, Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall. Calls to the company’s Canadian headquarters reached a recorded message that directed callers to the Hydroxycut Web site.
The recall of one of the best-known weight-loss brands is the latest in a series of incidents that raise the question of whether the Food and Drug Administration has adequate authority to regulate the dietary supplement industry and provide consumer protection.
At issue is the difference in the way the agency oversees drugs — defined as products that prevent or cure disease — and dietary supplements, which can offer general health benefits but cannot claim to treat specific diseases or symptoms.
Unlike drugs, whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products.
According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale.
“Part of the problem as you know is that F.D.A. looks at dietary supplements from a postmarket perspective, so that an isolated incident is often difficult to follow," Dr. Linda Katz, interim chief medical officer of the agency’s Center for Food Safety and Applied Nutrition, said Friday.
The agency has been on a campaign to identify and warn consumers about tainted weight-loss pills that illegally contain prescription drug ingredients. Since December, the F.D.A. has issued a list of 70 brands that contained hidden and potential hazardous drugs including an antiseizure medication.
Representatives of the industry said that current regulations were adequate to protect consumers because manufacturers conducted their own safety tests.
“Nobody goes to market without testing," said John Hathcock, vice president of scientific and international affairs at the Council for Responsible Nutrition, a trade group. He added that neither drug makers nor supplement manufacturers could ensure total product safety once an item moved from a testing lab into mass circulation.
The F.D.A. said that a new law that requires manufacturers to notify the agency of any reports of serious health problems helped officials identify a pattern of adverse events linked to Hydroxycut users. In addition, the agency cited reports in medical journals of serious liver disease being diagnosed in six people who had taken Hydroxycut.
The agency said the consumers were healthy before using Hydroxycut and took the recommended dose. Because the formula for Hydroxycut has changed over time and because the product contains different amounts of a proprietary blend of ingredients, the agency said it had not yet determined which of the product’s ingredients might constitute a health hazard.
Vitamin Shoppe and GNC said they were removing Hydroxycut products from their Web sites and stores. Several months ago, the companies stopped selling another well-known weight-loss brand, StarCaps, that was found to contain a powerful prescription diuretic.
A GNC spokeswoman wrote in an e-mail statement Friday, “As soon as we become aware of potential problems with any product, we take immediate action, as we have done in this situation."
Jak i infomacja bezposrednio z FDA:
FDA News
FOR IMMEDIATE RELEASE
May 1, 2009
Media Inquiries:
Susan Cruzan, 301-796-4540
Consumer Inquiries:
888-INFO-FDA
FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
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.
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.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products," said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
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. 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 agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
-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
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
+ tlumaczenie (byle jakie ale jest ze strony google)
FDA Aktualności
FOR IMMEDIATE RELEASE FOR IMMEDIATE RELEASE
May 1, 2009 1 maja 2009
Media Inquiries: Media Zapytania:
Susan Cruzan, 301-796-4540 Susan Cruzan, 301-796-4540
Consumer Inquiries: Zapytania Konsumentów:
888-INFO-FDA 888-INFO-FDA
FDA Warns Consumers to Stop Using Hydroxycut Products FDA ostrzega konsumentów do zaprzestania używania Hydroxycut Produkty
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury Dietetyczne dodatki związane z jedną Śmierć; Pose Ryzyko Urazy wątroby
The US Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, NY Some Hydroxycut products are associated with a number of serious liver injuries. The US Food and Drug Administration jest ostrzeżenie konsumentów do natychmiastowego zaprzestania używania produktów Hydroxycut przez Iovate Zdrowia Sciences Inc z Oakville, Ontario i dystrybuowane przez Iovate Health Sciences Inc z USA Blasdell, NY Hydroxycut Niektóre produkty są związane z szeregiem poważnych wątroby urazów. Iovate has agreed to recall Hydroxycut products from the market. Iovate wyraziła zgodę na wycofanie Hydroxycut produktów z rynku.
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. FDA otrzymała 23 sprawozdań poważnych problemów zdrowotnych, począwszy od żółtaczki i zwiększenie aktywności enzymów wątrobowych, który jest wskaźnikiem potencjału wątroby szkody, do uszkodzenia wątroby wymagające przeszczepu wątroby. One death due to liver failure has been reported to the FDA. Jedna śmierć w związku z niewydolnością wątroby został zgłoszony do 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. Inne problemy zdrowotne należą drgawki, zaburzenia układu krążenia i rabdomiolizy, rodzaj uszkodzenia mięśni, które mogą doprowadzić do poważnych problemów zdrowotnych, takich jak niewydolność nerek.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Wątroba szkody, choć rzadkie, były zgłaszane przez pacjentów w dawkach zalecanych Hydroxycut na butelce. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Objawy obejmują szkody wątroby żółtaczka (żółknięcia się skóry lub białek oczu) oraz brązowy moczu. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. Inne objawy obejmują nudności, wymioty, lekkie, kolorowe stolce, nadmiernego zmęczenia, osłabienie, ból brzucha lub ból, świąd, utrata apetytu.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. "FDA zachęca konsumentów do zaprzestania korzystania z Hydroxycut produktów w celu uniknięcia zbędnej ryzyka. Adverse events are rare, but exist. Zdarzenia niepożądane są rzadkie, ale istnieją. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products," said Linda Katz, MD, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition. Konsumenci powinni skonsultować się z lekarzem lub innych pracowników służby zdrowia, jeżeli występują objawy potencjalnie związane z tymi produktami ", powiedziała Linda Katz, MD, tymczasowy szef lekarskich funkcjonariusza FDA's Center for Applied Bezpieczeństwa Żywności i Żywienia.
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 produkty są suplementy, które są sprzedawane za weight-loss, jak tłuszcz palników, jak energia-enhancers jak niskie carb diet AIDS, oraz strat wody w Iovate i MuscleTech marek. Lista produktów przypomnieć przez Iovate obejmuje obecnie :
Hydroxycut Regular Rapid Release Caplets Hydroxycut Regularne Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets Hydroxycut Regularne Drink Pakiety
Hydroxycut Caffeine-Free Drink Packets Hydroxycut Caffeine-Free Drink Pakiety
Hydroxycut Hardcore Drink Packets (Ignition Stix) Hydroxycut Hardcore Drink Pakiety (zapłonu Stix)
Hydroxycut Max Drink Packets Hydroxycut Max Drink Pakiety
Hydroxycut Liquid Shots Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink) Hydroxycut Hardcore RTDs (Ready-to-drink)
Hydroxycut Max Aqua Shed Hydroxycut Max Aqua Shed
Hydroxycut 24 Hydroxycut 24
Hydroxycut Carb Control Hydroxycut Carb Control
Hydroxycut Natural Hydroxycut Naturalne
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. Chociaż FDA nie otrzymała sprawozdania wątroby poważnych działań niepożądanych związanych Hydroxycut dla wszystkich produktów, Iovate zgodziła się na wycofanie wszystkich produktów wymienionych powyżej. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Hydroxycut Oczyścić i Hoodia produkty nie są dotknięte przypomnieć. 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. Konsumenci, którzy któregokolwiek z produktów biorących udział w wycofywania zaleca się zaprzestać używania ich do powrotu do miejsca ich zakupu. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. Agencja nie ma jeszcze ustalona, które składniki, dawkach, lub inne związane ze zdrowiem czynniki mogą być związane z ryzykiem związanym z tymi Hydroxycut produktów. The products contain a variety of ingredients and herbal extracts. Produkty zawierają różne składniki i ekstrakty roślinne.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone. Pracownicy służby zdrowia i konsumentów są zachęcani do zgłaszania poważnych zdarzeń niepożądanych (działania niepożądane) lub jakości produktu problemy z wykorzystaniem tych produktów do FDA's Adverse Event Reporting MedWatch programu online, zwykłą pocztą, faksem lub telefonicznie.
-Online: www.fda.gov/MedWatch/report.htm -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 Regularne-Mail: Użyj FDA wysyłki formie wypłaconych 3500 pod adresem: www.fda.gov / MedWatch / getforms.htm i poczty do MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-Fax: 800-FDA-0178 -Fax: 800-FDA-0178
-Phone: 800-FDA-1088 -Telefon: 800-FDA-1088
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects. FDA nadal badać potencjał relacji między Hydroxycut suplementy i wątroby szkody lub inne potencjalnie poważne efekty uboczne.
linki:
http://www.nytimes.com/2009/05/02/business/02fda.html?_r=2&hp
http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html
http://translate.google.com/translate?prev=hp&hl=pl&js=n&u=http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html&sl=en&tl=pl
Zmieniony przez - BPL-G w dniu 2009-05-05 03:02:32
ze strony NY Times:
Hydroxycut Diet Aids Recalled After Warning
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Article Tools Sponsored By
By NATASHA SINGER
Published: May 1, 2009
Federal drug regulators warned consumers Friday to stop using the popular Hydroxycut line of weight-loss products, citing reports of a death due to liver failure and other instances of serious health problems.
In all, the Food and Drug Administration said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said.
The Hydroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the F.D.A.
That company, Iovate Health Sciences of Oakville, Ontario, and its American distributor are voluntarily recalling 14 of the products. Two other products, Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall. Calls to the company’s Canadian headquarters reached a recorded message that directed callers to the Hydroxycut Web site.
The recall of one of the best-known weight-loss brands is the latest in a series of incidents that raise the question of whether the Food and Drug Administration has adequate authority to regulate the dietary supplement industry and provide consumer protection.
At issue is the difference in the way the agency oversees drugs — defined as products that prevent or cure disease — and dietary supplements, which can offer general health benefits but cannot claim to treat specific diseases or symptoms.
Unlike drugs, whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products.
According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale.
“Part of the problem as you know is that F.D.A. looks at dietary supplements from a postmarket perspective, so that an isolated incident is often difficult to follow," Dr. Linda Katz, interim chief medical officer of the agency’s Center for Food Safety and Applied Nutrition, said Friday.
The agency has been on a campaign to identify and warn consumers about tainted weight-loss pills that illegally contain prescription drug ingredients. Since December, the F.D.A. has issued a list of 70 brands that contained hidden and potential hazardous drugs including an antiseizure medication.
Representatives of the industry said that current regulations were adequate to protect consumers because manufacturers conducted their own safety tests.
“Nobody goes to market without testing," said John Hathcock, vice president of scientific and international affairs at the Council for Responsible Nutrition, a trade group. He added that neither drug makers nor supplement manufacturers could ensure total product safety once an item moved from a testing lab into mass circulation.
The F.D.A. said that a new law that requires manufacturers to notify the agency of any reports of serious health problems helped officials identify a pattern of adverse events linked to Hydroxycut users. In addition, the agency cited reports in medical journals of serious liver disease being diagnosed in six people who had taken Hydroxycut.
The agency said the consumers were healthy before using Hydroxycut and took the recommended dose. Because the formula for Hydroxycut has changed over time and because the product contains different amounts of a proprietary blend of ingredients, the agency said it had not yet determined which of the product’s ingredients might constitute a health hazard.
Vitamin Shoppe and GNC said they were removing Hydroxycut products from their Web sites and stores. Several months ago, the companies stopped selling another well-known weight-loss brand, StarCaps, that was found to contain a powerful prescription diuretic.
A GNC spokeswoman wrote in an e-mail statement Friday, “As soon as we become aware of potential problems with any product, we take immediate action, as we have done in this situation."
Jak i infomacja bezposrednio z FDA:
FDA News
FOR IMMEDIATE RELEASE
May 1, 2009
Media Inquiries:
Susan Cruzan, 301-796-4540
Consumer Inquiries:
888-INFO-FDA
FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
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.
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.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products," said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
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. 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 agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
-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
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
+ tlumaczenie (byle jakie ale jest ze strony google)
FDA Aktualności
FOR IMMEDIATE RELEASE FOR IMMEDIATE RELEASE
May 1, 2009 1 maja 2009
Media Inquiries: Media Zapytania:
Susan Cruzan, 301-796-4540 Susan Cruzan, 301-796-4540
Consumer Inquiries: Zapytania Konsumentów:
888-INFO-FDA 888-INFO-FDA
FDA Warns Consumers to Stop Using Hydroxycut Products FDA ostrzega konsumentów do zaprzestania używania Hydroxycut Produkty
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury Dietetyczne dodatki związane z jedną Śmierć; Pose Ryzyko Urazy wątroby
The US Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, NY Some Hydroxycut products are associated with a number of serious liver injuries. The US Food and Drug Administration jest ostrzeżenie konsumentów do natychmiastowego zaprzestania używania produktów Hydroxycut przez Iovate Zdrowia Sciences Inc z Oakville, Ontario i dystrybuowane przez Iovate Health Sciences Inc z USA Blasdell, NY Hydroxycut Niektóre produkty są związane z szeregiem poważnych wątroby urazów. Iovate has agreed to recall Hydroxycut products from the market. Iovate wyraziła zgodę na wycofanie Hydroxycut produktów z rynku.
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. FDA otrzymała 23 sprawozdań poważnych problemów zdrowotnych, począwszy od żółtaczki i zwiększenie aktywności enzymów wątrobowych, który jest wskaźnikiem potencjału wątroby szkody, do uszkodzenia wątroby wymagające przeszczepu wątroby. One death due to liver failure has been reported to the FDA. Jedna śmierć w związku z niewydolnością wątroby został zgłoszony do 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. Inne problemy zdrowotne należą drgawki, zaburzenia układu krążenia i rabdomiolizy, rodzaj uszkodzenia mięśni, które mogą doprowadzić do poważnych problemów zdrowotnych, takich jak niewydolność nerek.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Wątroba szkody, choć rzadkie, były zgłaszane przez pacjentów w dawkach zalecanych Hydroxycut na butelce. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Objawy obejmują szkody wątroby żółtaczka (żółknięcia się skóry lub białek oczu) oraz brązowy moczu. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. Inne objawy obejmują nudności, wymioty, lekkie, kolorowe stolce, nadmiernego zmęczenia, osłabienie, ból brzucha lub ból, świąd, utrata apetytu.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. "FDA zachęca konsumentów do zaprzestania korzystania z Hydroxycut produktów w celu uniknięcia zbędnej ryzyka. Adverse events are rare, but exist. Zdarzenia niepożądane są rzadkie, ale istnieją. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products," said Linda Katz, MD, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition. Konsumenci powinni skonsultować się z lekarzem lub innych pracowników służby zdrowia, jeżeli występują objawy potencjalnie związane z tymi produktami ", powiedziała Linda Katz, MD, tymczasowy szef lekarskich funkcjonariusza FDA's Center for Applied Bezpieczeństwa Żywności i Żywienia.
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 produkty są suplementy, które są sprzedawane za weight-loss, jak tłuszcz palników, jak energia-enhancers jak niskie carb diet AIDS, oraz strat wody w Iovate i MuscleTech marek. Lista produktów przypomnieć przez Iovate obejmuje obecnie :
Hydroxycut Regular Rapid Release Caplets Hydroxycut Regularne Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets Hydroxycut Regularne Drink Pakiety
Hydroxycut Caffeine-Free Drink Packets Hydroxycut Caffeine-Free Drink Pakiety
Hydroxycut Hardcore Drink Packets (Ignition Stix) Hydroxycut Hardcore Drink Pakiety (zapłonu Stix)
Hydroxycut Max Drink Packets Hydroxycut Max Drink Pakiety
Hydroxycut Liquid Shots Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink) Hydroxycut Hardcore RTDs (Ready-to-drink)
Hydroxycut Max Aqua Shed Hydroxycut Max Aqua Shed
Hydroxycut 24 Hydroxycut 24
Hydroxycut Carb Control Hydroxycut Carb Control
Hydroxycut Natural Hydroxycut Naturalne
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. Chociaż FDA nie otrzymała sprawozdania wątroby poważnych działań niepożądanych związanych Hydroxycut dla wszystkich produktów, Iovate zgodziła się na wycofanie wszystkich produktów wymienionych powyżej. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Hydroxycut Oczyścić i Hoodia produkty nie są dotknięte przypomnieć. 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. Konsumenci, którzy któregokolwiek z produktów biorących udział w wycofywania zaleca się zaprzestać używania ich do powrotu do miejsca ich zakupu. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. Agencja nie ma jeszcze ustalona, które składniki, dawkach, lub inne związane ze zdrowiem czynniki mogą być związane z ryzykiem związanym z tymi Hydroxycut produktów. The products contain a variety of ingredients and herbal extracts. Produkty zawierają różne składniki i ekstrakty roślinne.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone. Pracownicy służby zdrowia i konsumentów są zachęcani do zgłaszania poważnych zdarzeń niepożądanych (działania niepożądane) lub jakości produktu problemy z wykorzystaniem tych produktów do FDA's Adverse Event Reporting MedWatch programu online, zwykłą pocztą, faksem lub telefonicznie.
-Online: www.fda.gov/MedWatch/report.htm -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 Regularne-Mail: Użyj FDA wysyłki formie wypłaconych 3500 pod adresem: www.fda.gov / MedWatch / getforms.htm i poczty do MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-Fax: 800-FDA-0178 -Fax: 800-FDA-0178
-Phone: 800-FDA-1088 -Telefon: 800-FDA-1088
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects. FDA nadal badać potencjał relacji między Hydroxycut suplementy i wątroby szkody lub inne potencjalnie poważne efekty uboczne.
linki:
http://www.nytimes.com/2009/05/02/business/02fda.html?_r=2&hp
http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html
http://translate.google.com/translate?prev=hp&hl=pl&js=n&u=http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html&sl=en&tl=pl
Zmieniony przez - BPL-G w dniu 2009-05-05 03:02:32
Krzysztof Piekarz
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