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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FRIDAY, Oct. 8 – The obesity drug Meridia has been withdrawn from the U.S. market because of an increased risk of heart attack and stroke, federal health officials said Friday.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
Related support groups: Meridia
FDA MedWatch - Meridia (sibutramine): Early Communication about cardiovascular events
Posted 1 Dec 2009 by Drugs.com
Audience: Cardiology and endocrinology healthcare professionals ROCKVILLE, Nov. 21, 2009-FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and FDA is making n ... Read more
Related support groups: Meridia
FDA Medwatch Alert: Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) - Serotonin Syndrome
Posted 19 Jul 2006 by Drugs.com
[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, ... Read more