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Sibutramine FDA Alerts

The FDA Alerts below may be specifically about sibutramine or relate to a group or class of drugs which include sibutramine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for sibutramine

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Oct 16, 2018 | Audience: Consumers

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis  has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

Risk Statement: Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated Sibutramine poses an increased risk of heart attack and stroke.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. To date, Fat Burners Zone has not received any reports of adverse events related to this recall.

This tainted product is marketed as a dietary supplement for weight loss and is packaged in gray aluminum bottles with gray aluminum caps, 30 capsules per bottle. The affected Zero Xtreme lot, #1220062085, expires 03/2020. Zero Xtreme was distributed nationwide via internet through the website fatburnerszone.com.

Fat Burners Zone is notifying its distributors and customers by a recall letter sent by email and is arranging for return/replacement of all recalled products. Consumers that have Zero Xtreme, which is being recalled, should return to place of purchase and contact their doctor.

Consumers with questions regarding this recall can contact Fat Burners Zone at (305) 741-2562 or at usa@fatburnerszone.com. Monday through Friday from 9:00 AM to 5:00 PM, EST time zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 

Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine

Feb 27, 2018 | Audience: Consumer

ISSUE: Bella All Natural is voluntarily recalling its Diet Capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level.

This recall has been initiated due to presence of sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.

BACKGROUND: The product is used as a diet pill and is packaged in a plastic bottle, with 30 pills, and with the Lot Number MFD:10.15.2017 EXP: 10.14.2019. Bella was distributed in California via internet and retail.

RECOMMENDATION: Bella All Natural is notifying its distributors and customers by Customer Notification/Recall Communication and is arranging for return of product of all recalled products. Consumers that have Bella Diet Capsules which is being recalled should stop using immediately and return to place of purchase.

Consumers with questions regarding this recall can contact Bella all Natural by calling (323) 552-6263, or e-mail address: cabral_daisy@yahoo.com on Monday-Sunday, 10 a.m. - 5:30 p.m., PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[02/22/2018 - Press Release - Bella All Natural]
 

LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

Mar 30, 2017 | Audience: Consumer

ISSUE: Envy Me is recalling LaBri’s Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The recall includes all lot codes, manufacturing codes and expiration dates. 

The FDA analyzed samples of La Bri’s Body Health Atomic and found it to contain the undeclared ingredient sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.

BACKGROUND: The recall is being conducted to the consumer level. The products were sold nationwide through internet sales.

RECOMMENDATION: Consumers should stop using the product immediately and throw it away in accordance with your state and local ordinances for drug products or return the unused portion of product for a refund or replacement. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[03/30/2017 - Press Release - Envy Me]

Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients

Dec 23, 2015 | Audience: Consumer

[Posted 12/23/2015]

ISSUE: Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein. 

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

To date, Bee Extremely Amazed is not aware of any adverse event reports related to these products. See the Firm Press Release for a complete list of the recalled products.

BACKGROUND: The affected products were sold nationwide between 4/29/2014 – 12/17/2015 via distribution/resale via the U.S. Postal service with the return addressee referenced as Bee Extremely Amazed, LLC.

RECOMMENDATION: Bee Extremely Amazed LLC is notifying its customers to stop using these products immediately and dispose of or return all recalled products to Bee Extremely Amazed 85205 Sportsmans Club Road Jewett Ohio 43986. Consumers should contact their physician or healthcare provider if they have any health questions or have experienced any problems that may be related to taking or using this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[12/22/2015 - Press Release - Bee Extremely Amazed LLC]

La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients

Dec 23, 2015 | Audience: Consumer

[Posted 12/23/2015]

ISSUE: BeeXtreme LLC is recalling all lots of La' Trim Plus, Jenesis and Oasis products from the market. Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La' Trim Plus", “Oasis”, and “Jenesis”.  The recall includes all lots and expiration dates.

BACKGROUND: Sibutramine and Phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. It is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious, gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

RECOMMENDATION: Please determine if you have any of the above products on hand. If so, please discontinue selling the products and do not consume them. Please promptly dispose of all identified products. If you have further distributed La' Trim, Jenesis and/or Oasis, please contact your customers if possible and advise them of the recall situation. Provide them with a copy of this notice. Have them return their outstanding recalled stocks to you. If you have any questions regarding this recall please contact beextremellc@gmail.com or call 814-771-4377.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[12/23/2015 - Press Release - BeeXtreme LLC]

Smart Lipo: Recall - Undeclared Drug Ingredients

Dec 18, 2015 | Audience: Consumer

[Posted 12/18/2015]

ISSUE: SmartLipo365 is voluntarily recalling all lots of Smart Lipo (800, 900, 950 mg) capsules to the consumer level. FDA's analysis found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Smart Lipo 365 has not received any complaints associated with this product to date.

BACKGROUND: Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules in 800mg, 900mg, and 950mg per capsule. The affected Smart Lipo products include all expiration dates:. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.com.

RECOMMENDATION: SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Distributors and retailers should check their inventory and discontinue the Smart Lipo products. Consumers should immediately discontinue the use of these products.

Consumers with questions regarding this recall can contact SmartLipo365 by calling 972-757-8136 on Monday through Friday from 10 A.M. to 5 P.M. (Central time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

[12/18/2015 - Press Release - SmartLipo365]
 

SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients

Dec 21, 2014 | Audience: Consumer

[Posted 12/22/2014]

ISSUE: Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of SLIM-K collected and tested by the FDA was found to contain sibutramine, desmethylsibutramine, and phenolphthalein. Products containing sibutramine pose a threat to consumers besause sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

No illnesses or injuries have been reported to the company to date in connection with this product.


BACKGROUND: Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.

SLIM-K Capsules are marketed as a Natural Herbal Supplement for Weight Loss. SLIM-K blue and white capsules are packaged in white plastic bottles containing 30 Capsules per bottle, and labeled with Lot # 140430, Expiration 12/2017, and barcode 160126417509.


RECOMMENDATION: Consumers should not consume SLIM-K Capsules and should return it immediately to the place of purchase. Consumers with questions should contact Kariny Ramirez by phone at (212) 568-5330, Monday - Friday, 11:00 am - 4:00 pm, ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[12/19/2014 - Firm Press Release - FDA]

Slim-Vie: Public Notification - Undeclared Drug Ingredient

Nov 26, 2014 | Audience: Consumer

[Posted 11/26/2014]

ISSUE: FDA is advising consumers not to purchase or use Slim Vie. FDA laboratory analysis confirmed that Slim-Vie contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

BACKGROUND: Slim Vie is promoted and sold for weight loss on various websites, and possibly in some retail stores.

RECOMMENDATION: Do not to purchase or use Slim Vie. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/25/2014 - Public Notification - FDA]
[11/25/2014 - Tainted Weight Loss Products - FDA]

V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient

Nov 5, 2014 | Audience: Consumer

ISSUE:  FDA is advising consumers not to purchase or use V26 Slimming Coffee. FDA laboratory analysis confirmed that V26 Slimming Coffee contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

BACKGROUND: V26 Slimming Coffee is a product promoted and sold for weight loss on various websites and possibly in some retail stores.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/04/2014 - Public Notification - FDA]
[11/04/2014 - Tainted Weight Loss Products - FDA]

Sit and Slim II: Public Notification - Hidden Drug Ingredients

Oct 10, 2014 | Audience: Consumer

[Posted 10/10/2014]

ISSUE: The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II.

FDA laboratory analysis confirmed that Sit and Slim II contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.
 
Laboratory analysis also confirmed that Sit and Slim contains phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
 
BACKGROUND: Sit and Slim II is a product promoted and sold for sexual enhancement on various websites and in some retail stores. See the Public Notification for a product photo.

RECOMMENDATION:  Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[10/10/2014 - Public Notification - FDA]

Asset Bold: Public Notification - Undeclared Drug Ingredient

May 16, 2014 | Audience: Consumer

[Posted 05/16/2014]

ISSUE: FDA is advising consumers not to purchase or use Asset Bold, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Asset Bold contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

BACKGROUND: Asset Bold is a product promoted and sold for weight loss on various websites and in some retail stores.

RECOMMENDATION: Do not purchase or use Asset Bold.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/16/2014 - Public Notification - FDA]

Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient

Mar 19, 2014 | Audience: Consumer

[Posted 03/19/2014]

ISSUE: FDA is advising consumers not to purchase or use Vitaccino Coffee, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Vitaccino Coffee contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers, because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients. Sibutramine may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

BACKGROUND: Vitaccino Coffee is sold on various websites and in some retail stores.

RECOMMENDATION: Do not purchase or use Vitaccino Coffee.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[03/19/2014 - Public Notification - FDA]

Related FDA Safety Information

[03/19/2014 - Tainted Weight Loss Products - FDA]
 

JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient

Jun 28, 2013 | Audience: Consumer

ISSUE: Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi”  Weight Loss Supplement.  These product have been found to contain undeclared Sibutramine, Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

Products containing Sibutramine pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. The company has not received any reports of adverse events related to this recall. The recall was initiated after discovering that Sibutramine was included as an ingredient by the manufacturer.

BACKGROUND: JaDera Weight Loss Supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of # 30 capsules. The affected JaDera Weight Loss Supplement, includes manufactured lot 10.06.2011 with Expiration Date: 09.06.2013. JaDera Weight Loss Supplement was distributed Nationwide to consumers and distributors. The products were distributed from May 2011 to May 2013.

Xiyouji Qingzhi Weight Loss Supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of # 30 capsules of 300mg. The affected Xiyouji Qingzhi Weight Loss Supplement, includes all lots. The products were distributed from May 2011 to May 2013.

RECOMMENDATION: Consumers and distributors that have product which is being recalled should stop using the products and return the product to Dolphin Intertrade Corp. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[06/28/2013 - Press Release - Dolphin Intertrade Corp]

-

Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient.

Jun 11, 2013 | Audience: Consumer

ISSUE: A sample of Bethel 30 green capsule was collected and tested by FDA  and found positive for Sibutramine and Phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.The FDA has not approved Bethel 30, green capsules as drugs; therefore the safety and effectiveness of this product is unknown.

BACKGROUND: Bethel 30, green capsules are marketed as a Natural Herb for Weight Loss.  Bethel 30 Herb Supplement is packaged in plastic white bottles containing 30 capsules per bottle and bears Lot #’s 120514, with EXP: 12/05/2014. The lot 120514 is the only one subject to recall.

RECOMMENDATION: Consumers should not consume Bethel 30, green capsules, Herb Supplement and should return it immediately to the place of purchase for a refund. Consumers with questions should contact Kariny Ramirez 212-568-5330, Monday - Friday, 10:00 am - 4:00 pm, EDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[06/11/2013 - Firm Press Release - Bethel Nutritional Consulting, Inc.]

Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient

Feb 25, 2013 | Audience: Consumer

ISSUE: Olaax Corp announced a nationwide recall of the company's dietary supplement sold under the brand name Maxiloss Weight Advanced Softgels to the user level, because FDA testing found the Maxiloss Weight Advanced product to contain Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from U.S marketplace. The active drug ingredient is not listed on the label for these products.

The recall includes ALL authentic lot numbers and known to be counterfeit lot numbers of authentic lots. Any packaging types that are different from listed are counterfeit. Any lot numbers not listed are counterfeit and are also part of the recall.

BACKGROUND: Maxiloss Weight Advanced Softgels is marketed as a Natural Herb for Weight Loss. The product is packaged in a green or blue box containing 3 X 12 blister packs per box and bears "Batch Number: 001". The product was sold to distributors nationwide, and known-to-be counterfeit versions are sold on various online sites. This product was distributed nationwide in US from January 2011 to November 2012.

RECOMMENDATION: Consumers with questions regarding this recall can contact Olaax Corporation at 1-863-648-9581, Monday through Friday, 9:00 am to 5:30 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.


[02/25/2013 - Press Release - Olaax Corp]

SLIMDIA Revolution: Public Notification - Contains Undeclared Drug Ingredient Sibutramine

Dec 21, 2012 | Audience: Consumer

UPDATED 12/21/2012  P&J Trading announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements sold under the brand name SLIMDIA REVOLUTION after being notified by FDA that testing found the SLIMDIA REVOLUTION products contain Sibutramine

Posted 12/20/2012

ISSUE: FDA is advising consumers not to purchase or use “SLIMDIA Revolution,” a product promoted and sold for weight loss on various websites, including www.pinkfatty.com, and in some retail stores.

FDA laboratory analysis confirmed that “SLIMDIA Revolution” contains Sibutramine.

BACKGROUND: Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

RECOMMENDATION: Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall - Undeclared Sibutramine

Oct 31, 2012 | Audience: Consumers

ISSUE: TZi Xiu Tang Success, LLC is voluntarily recalling four lots of Classic Zi Xiu Tang Bee Pollen Capsules, and three lots of Ultimate Formula Capsules to the consumer level. These products have been found to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, making these products unapproved new drugs.

Products containing Sibutramine pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. The company has not received any reports of adverse events related to this recall. The recall was initiated after discovering that Sibutramine was included as an ingredient by the manufacturer.

BACKGROUND: The Classic Zi Xiu Tang Bee Pollen product is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of 60 capsules. The affected Classic Zi Xiu Tang with UPC 6937000700019, includes the following lot numbers - lots 04/15/2012, 05/15/2012, 06/15/2012 and 07/15/2012. Classic Zi Xiu Tang was distributed Nationwide to consumers and distributors. The products were distributed from May 1, 2012 to October 17, 2012.

The Ultimate Formula product is also marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of 48 capsules. The affected Ultimate Formula with UPC 793573041401, includes the following lot numbers – 05/25/2012, 07/29/2012 and 08/05/2012. The Ultimate Formula was distributed Nationwide to consumers and distributors. The products were distributed from May 1, 2012 to October 17, 2012.

RECOMMENDATION: Zi Xiu Success, LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using the products and return the product to Zi Xiu Success, LLC. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[10/31/2012 - Press Release - Zi Xiu Tang Success, LLC] 
 

Celerite Slimming Tea: Recall - Undeclared Drug Ingredient

Mar 28, 2011 | Audience: Consumer

[Posted 03/28/2011]

ISSUE: FDA laboratory analyses of the product were found to contain undeclared Sibutramine, which is used as an appetite suppressant for weight loss. The FDA has not approved the product as a drug; therefore, the safety and effectiveness of the product is unknown. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

BACKGROUND: The product was sold and distributed nationwide via the internet at www.shapingbeauty.com

RECOMMENDATION: Consumers are advised to return the product to the company’s address in Southampton, PA.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[03/15/2011 - Press Release - Shaping Beauty, Inc.]
[01/12/2011 - Tainted Weight Loss Products - FDA]

Related MedWatch alert:

[01/13/2011 - Celerite Slimming Capsules]

    

Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

Oct 8, 2010 | Audience: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

[10/08/2010 - Drug Safety Communication - FDA]
[10/08/2010 - Questions and Answers - FDA]
[10/08/2010 - News Release - FDA]

Previous MedWatch Alert:

[01/21/2010 - Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review]

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review

Jan 21, 2010 | Audience: Cardiology and endocrinology healthcare professionals

FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

  • History of coronary artery disease (e.g., heart attack, angina)
  • History of stroke or transient ischemic attack (TIA)
  • History of heart arrhythmias
  • History of congestive heart failure
  • History of peripheral arterial disease
  • Uncontrolled hypertension (e.g., > 145/90 mmHg)

Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.

[01/21/2010 - Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia - FDA]

Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) - Serotonin Syndrome

Jul 19, 2006 | Audience: Neuropsychiatric and other healthcare professionals, and consumers[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together.

[July 19, 2006]