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Meridia News

Charges Filed Against Makers of Nutritional Supplements

Posted 18 Nov 2015 by Drugs.com

WEDNESDAY, Nov. 18, 2015 – Criminal charges and civil injunctions have been filed against 117 makers and/or distributors of potentially dangerous dietary supplements, U.S. government agencies announced Tuesday. One of the targets of the investigation – conducted by the U.S. Food and Drug Administration, the Department of Justice and other federal agencies – was USPlabs LLC of Dallas, which sold popular workout and weight loss supplements. The government says USPlabs and its executives claimed to use natural plant extracts in products called Jack3d and OxyElite Pro. However, they actually used a synthetic stimulant made in a Chinese chemical factory and knew of studies that linked these products to liver toxicity, the government said. In October 2013, USPlabs said it would stop distribution of OxyElite Pro because it had been linked to an outbreak of liver damage. However, the company ... Read more

Related support groups: Belviq, Dietary Supplementation, Vitamin/Mineral Supplementation and Deficiency, Liver Cirrhosis, Poisoning, Meridia, Sibutramine, Organ Transplant, Lorcaserin, Liver and Pancreatic Disease, Toxic Reactions Incl Drug and Substance Abuse, Dietary Fiber Supplementation

FDA Seizes Counterfeit Drugs, Devices Sold Online

Posted 18 Jun 2015 by Drugs.com

THURSDAY, June 18, 2015 – The U.S. Food and Drug Administration, along with international partners, moved this week against more than 1,050 websites that sell potentially dangerous counterfeit medicines and medical devices, the agency said Thursday. Illegal medicines and medical devices were seized worldwide, and warnings were sent to the operators of offending websites, the FDA said in a news release. "Our efforts to protect the health of American patients by preventing the online sale of potentially dangerous illegal medical products will not cease," said George Karavetsos, director of the FDA's Office of Criminal Investigations. Counterfeit prescription drugs that claim to be generic versions of brand-name drugs that are sold illegally on the websites include generic Nolvadex, generic Meridia, generic Valium, generic Truvada and generic Advair Diskus, according to the FDA. Mail ... Read more

Related support groups: Depression, Sleep Disorders, Wellbutrin, Insomnia, Major Depressive Disorder, Valium, Erectile Dysfunction, Bupropion, Viibryd, Wellbutrin XL, Wellbutrin SR, Brintellix, Advair Diskus, Zyban, 5-HTP, St. John's Wort, Truvada, Meridia, Vortioxetine, Budeprion

FDA Medwatch Alert: V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient

Posted 5 Nov 2014 by Drugs.com

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 ... Read more

Related support groups: Dietary Supplementation, Meridia, Sibutramine

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

Posted 1 Jul 2013 by Drugs.com

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 initiate ... Read more

Related support groups: Obesity, Meridia, Sibutramine

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

Posted 11 Jun 2013 by Drugs.com

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 b ... Read more

Related support groups: Obesity, Meridia, Sibutramine

FDA Medwatch Alert: Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient

Posted 26 Feb 2013 by Drugs.com

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 ... Read more

Related support groups: Obesity, Meridia, Sibutramine

FDA Medwatch Alert: SLIMDIA Revolution: Public Notification - Contains Undeclared Drug Ingredient Sibutramine

Posted 11 Jan 2013 by Drugs.com

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 ... Read more

Related support groups: Dietary Supplementation, Meridia, Sibutramine

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

Posted 1 Nov 2012 by Drugs.com

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 ... Read more

Related support groups: Dietary Supplementation, Meridia, Sibutramine

U.S. Women Using Dangerous Weight-Loss Pill 2 Years After Recall

Posted 16 Aug 2011 by Drugs.com

TUESDAY, Aug. 16 – Many women in the United States continue to use a Chinese weight-loss supplement that's been recalled due to dangerous ingredients, a new study indicates. Pai You Guo contains the pharmaceuticals sibutramine and phenolphthalein, both of which are banned in the United States because they increase the risk of heart attack, stroke and cancer. The U.S. Food and Drug Administration announced a recall of Pai You Guo in 2009 but it appears to have had little effect on the number of women using the weight-loss product, this study suggests. Harvard Medical School researchers surveyed more than 550 women who were born in Brazil and live in greater Boston and found that nearly one-quarter of them have used or currently use Pai You Guo. Most of the women using the supplement have experienced side effects such as insomnia, palpitations, fainting and addiction to the product. The ... Read more

Related support groups: Obesity, Meridia, Sibutramine, Phenolax, Espotabs, Prulet, Phenolphthalein, Chocolaxed, Medilax

FDA Medwatch Alert: Celerite Slimming Tea: Recall - Undeclared Drug Ingredient

Posted 16 Apr 2011 by Drugs.com

[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 F ... Read more

Related support groups: Obesity, Meridia, Sibutramine

Weight-Loss Drug Meridia Pulled From U.S. Market

Posted 9 Oct 2010 by Drugs.com

FRIDAY, Oct. 8 – The obesity drug Meridia has been withdrawn from the U.S. market because of an increased risk of heart attack and stroke, federal health officials said Friday. Pharmaceutical giant Abbott Laboratories voluntarily agreed to pull the drug after a U.S. Food and Drug Administration review of data that showed a 16 percent increased risk for heart attack, stroke and death among people taking Meridia (sibutramine), compared with those taking a placebo. Earlier Friday, Health Canada, the nation's health department, said Abbott would voluntarily pull the drug from the market there. "FDA requested this withdrawal after concluding that the continued availability of this product is not justified since patients taking the drug are at an increased risk of suffering a heart attack or stroke," Dr. John Jenkins, director of the Office of New Drugs in FDA's Center for Drug Evaluation ... Read more

Related support groups: Meridia, Sibutramine

FDA to Ask Experts to Weigh Restrictions for Diet Pill, Including Withdrawal From Market

Posted 14 Sep 2010 by Drugs.com

US Agency to Ask Experts to Weigh Restrictions for Diet Pill, Including Withdrawal From Market From Canadian Press DataFile (September 13, 2010) WASHINGTON – Almost a year after studies showed the diet pill Meridia increases heart attack and stroke risk, U.S. health regulators announced they will consider pulling the Abbott Laboratories’ drug off the market. Meridia has been sold since 1997, but data released in November showed patients with heart disease taking the drug had a more than 11 per cent risk of cardiovascular risks compared with 10 per cent of those taking a placebo. European regulators pulled the product off the market in January. However, the FDA said Monday that it is considering a range of options for the drug, including simply adding more warning labels. A 170-page FDA review posted online contains analyses by half a dozen agency scientists, at least two of whom seem t ... Read more

Related support groups: Meridia

FDA Panel to Mull Ban on Diet Drug Meridia

Posted 13 Sep 2010 by Drugs.com

MONDAY, Sept. 13 – The U.S. Food and Drug Administration will ask an expert panel later this week whether or not the diet drug Meridia should be banned due to suspected heart risks. In documents released Monday ahead of the panel meeting, which begins Wednesday, the agency said that members of its Endocrinologic & Metabolic Drugs Advisory Committee will be asked to consider a number of options, including taking no action, adding label warnings and/or restrictions to the use of Meridia, or to withdraw [Meridia] from the U.S. market. The meeting comes on the heels of a study released earlier this month that linked the drug to an increased risk of nonfatal heart attacks and stroke, although taking the drug did not seem to up the risk of death in patients with a history of heart problems. The trial involved almost 11,000 older, overweight or obese adults with type 2 diabetes or heart ... Read more

Related support groups: Meridia

Diet Pill Meridia Ups Heart Attack Risk: Study

Posted 2 Sep 2010 by Drugs.com

WEDNESDAY, Sept. 1 – A new study is linking the popular weight loss drug Meridia to an increased risk of non-fatal heart attacks and stroke, although taking the drug did not seem to up the risk of death in patients with a history of heart problems. The finding is stirring mixed reactions from experts. According to the authors of the trial, which was funded by Meridia's maker, Abbott, the findings are generally in line with what has been known about the drug and shouldn't change how it is used. "The only time you've got an increase in heart attacks or strokes were in those patients who had had previous heart disease or strokes, in other words, the people who . . . should never have received the drug in the first place," said Dr. Philip T. James, a professor at the London School of Hygiene and Tropical Medicine in England, and first author on the paper, which appears in the Sept. 2 issue ... Read more

Related support groups: Meridia

Consumer Advocate Asks FDA to Ban Weight Loss Pill

Posted 4 Dec 2009 by Drugs.com

From Associated Press (December 3, 2009) WASHINGTON--A consumer advocacy group is petitioning the government to ban the weight loss pill Meridia because a recent study suggests it increases risk of heart attack, stroke and death. A letter Thursday from Public Citizen calls on the Food and Drug Administration to pull Abbott Laboratories' drug from the U.S. market, where it is used by roughly a quarter million people. Preliminary results from a 10,000-patient study _ known as the SCOUT study _ showed a slightly higher risk of heart-related problems in patients taking Meridia, also called sibutramine, compared with a dummy pill. Patients in the study were older than 55, overweight with a history of heart disease or diabetes. FDA said it was "making no conclusions about the preliminary findings," when they were released last month. But Public Citizen's Dr. Sidney Wolfe said the agency ... Read more

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