Jeffrey Salazar
Sibutramine is a weight-loss drug that was previously prescribed as a treatment for obesity. It was withdrawn from the market in several countries in 2010, including the US, Canada, the UK, and the European Union, due to concerns over increased cardiovascular risks. Despite the ban, weight-loss pills containing sibutramine can still be purchased online and have been found in products marketed as natural or herbal supplements. It is important to be aware of the potential health risks associated with sibutramine and to consult a doctor before taking any weight-loss medication.
| Characteristics | Values |
|---|---|
| Purpose | Weight loss |
| Medical use | Treatment of obesity |
| Mechanism | Appetite suppression |
| Dosage | 10 mg/d or 15 mg/d |
| Side effects | Headache, dizziness, fast heart rate, constipation, nausea, dry mouth, insomnia |
| Precautions | Should not be taken with other medicines that make you sleepy, should not be taken for longer than 2 years, should be stored at room temperature away from moisture, heat, and light |
| Withdrawal | Withdrawn from the US market in 2010 due to increased risk of cardiovascular events, heart attacks, and strokes |
| Availability | Still available in some countries, can be purchased illegally online |
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What You'll Learn
Sibutramine is an appetite suppressant
Sibutramine is a weight-loss agent that was previously prescribed as an appetite suppressant. It was sold under brand names such as Meridia, Reductil, Siredia, and Sibutrex. The drug was widely marketed and prescribed until 2010 as an adjunct in the treatment of obesity alongside diet and exercise.
Sibutramine was developed in 1988 in Nottingham, UK, and was manufactured and marketed by Abbott Laboratories. It is a serotonin and norepinephrine reuptake inhibitor (SNRI) similar to certain antidepressants. It induces weight loss by affecting food intake and energy expenditure. Clinical trials have shown that it can lead to a weight loss of up to 11% when combined with a low-calorie diet, and patients can lose up to 15% of their weight over a one-year period.
Despite its effectiveness in promoting weight loss, sibutramine has been associated with adverse cardiovascular events, including increased risk of heart attack and stroke, and cardiac arrest, even in individuals without pre-existing cardiovascular disease. As a result, it has been withdrawn from the market in several countries, including the United States, Canada, the European Union, China, India, Australia, and the United Kingdom.
However, sibutramine remains available in some countries, and it has been found in dietary supplements and weight loss products sold online and in other markets. These products are often labelled as "natural", "herbal", or dietary supplements, and may not always list sibutramine as an ingredient. Consumers who buy these products may unknowingly ingest sibutramine, which can pose serious health risks.
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It was sold under the brand name Meridia
Sibutramine is the generic name for the drug formerly sold under the brand name Meridia. It was approved by the US Food and Drug Administration (FDA) in November 1997 for weight loss and the maintenance of weight loss in people with a body mass index (BMI) of 30 or higher, or for people with a BMI of 27 or higher who have other cardiovascular risk factors.
Meridia was sold as an appetite suppressant and was widely marketed and prescribed as an adjunct in the treatment of obesity alongside diet and exercise. It was developed in 1988 in Nottingham, UK, and was manufactured and marketed by Abbott Laboratories. It was sold under a variety of brand names, including Reductil, Siredia, and Sibutrex, in addition to Meridia.
Meridia was withdrawn from the US market in October 2010, following an FDA recommendation against its continued prescribing and use due to concerns over unnecessary cardiovascular risks to patients. Abbott Laboratories voluntarily withdrew the drug from the market, citing concerns over minimal efficacy coupled with increased risk of adverse cardiovascular events. The FDA's recommendation was based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in the risk of major adverse cardiovascular events.
Despite its withdrawal in the US, Meridia remains available in some countries. However, it has been discontinued in many countries and regions, including Australia, Canada, China, the European Union, Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States.
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It was withdrawn from the US market in 2010
Sibutramine, sold under the brand name Meridia, among others, is an appetite suppressant that functions as a serotonin-norepinephrine reuptake inhibitor (SNRI). It was widely marketed and prescribed as an adjunct in the treatment of obesity along with diet and exercise until 2010.
In 2008, the FDA issued an alert regarding 27 products marketed as dietary supplements for weight loss that illegally contained undisclosed amounts of sibutramine. In 2009, a study by Dieter Müller et al. highlighted cases of sibutramine poisoning from Chinese "herbal supplements" sold in Europe, containing double the dosage of the licensed drug. This was followed by the FDA recalling 34 additional products, underlining the dangers of unregulated herbal supplements.
In November 2009 and January 2010, the FDA announced it was reviewing clinical trial data that indicated a potentially serious impact on heart health from the use of Meridia. On January 21, 2010, the European Medicines Agency recommended suspending marketing authorizations for sibutramine based on the SCOUT study results, which revealed a 16% increased risk of major adverse cardiovascular events.
On October 8, 2010, the FDA recommended against continued prescribing and requested that Abbott Laboratories, the manufacturer of Meridia, voluntarily withdraw the drug from the US market. Abbott Laboratories agreed to cease marketing Meridia in the United States, citing concerns over minimal efficacy and heightened risks of adverse cardiovascular events. The FDA's recommendation was based on data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated an elevated risk of cardiovascular complications. This decision was influenced by the SCOUT study's findings, which showed a 16% increased risk of significant cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, the need for resuscitation after cardiac arrest, and cardiovascular death.
As a result of these concerns and the availability of alternative weight loss medications, sibutramine was withdrawn from the US market in 2010. Despite this, sibutramine has still been found in dietary supplements and weight loss products sold online and in other countries after its withdrawal from the US market.
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It is linked to adverse cardiovascular events
Sibutramine is a weight loss agent that was withdrawn from the market in the USA and European Union because it increases adverse events in patients with cardiovascular diseases. It has been associated with an increased risk of cardiovascular diseases and strokes and has been withdrawn from the market in several countries and regions.
In December 2008, the FDA issued an alert listing 27 products marketed as "dietary supplements" for weight loss that illegally contained undisclosed amounts of sibutramine. In March 2009, a study was published on sibutramine poisoning cases from Chinese "herbal supplements" sold in Europe, containing twice the dosage of the licensed drug. An additional 34 products were recalled by the FDA in April 2009.
In 2010, the FDA recommended against continued prescribing of sibutramine due to unnecessary cardiovascular risks to patients. Abbott Laboratories, which manufactured and marketed sibutramine under brand names including Reductil, Meridia, Siredia, and Sibutrex, withdrew the drug from the US market. The same year, Health Canada advised the public that illegal "Herbal Diet Natural" supplements containing sibutramine were found on the market. The FDA also notified consumers that "Slimming Beauty Bitter Orange Slimming Capsules" contained sibutramine, which was not listed on the product label.
Sibutramine has been shown to increase QT dispersion, which is associated with an increased risk of ventricular tachyarrhythmias. It also inhibits the hERG potassium channel, contributing to drug-induced QT interval prolongation and cardiac arrhythmias. This mechanism may cause prolongation of the QT interval, increasing the risk of cardiac arrest.
Several cardiovascular adverse events have been reported in sibutramine-treated patients, including hypertension, tachycardia, arrhythmias, myocardial infarction, and ischemic stroke. These adverse events have led to the contraindication of sibutramine in patients with established coronary heart disease, previous strokes, heart failure, or cardiac arrhythmias. The long-term effects of sibutramine treatment on cardiovascular events and cardiovascular death are still unknown.
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It is still found in some diet supplements
Although sibutramine was withdrawn from the market in 2010 in several countries and regions, including the United States, Canada, the European Union, China, Australia, and more, it is still found in some diet supplements.
In December 2008, the FDA issued an alert regarding 27 different products marketed as "dietary supplements" for weight loss that illegally contained undisclosed amounts of sibutramine. Similarly, in March 2009, a study found that some "herbal supplements" sold in Europe contained sibutramine, with doses as high as twice the legal limit.
The FDA has continued to issue warnings about weight loss products containing sibutramine, including alerts in 2010 about "Slimming Beauty Bitter Orange Slimming Capsules" and "Fruta Planta" dietary products. In 2011, illegal weight loss products imported into Ireland were found to contain sibutramine, and similar concerns were raised in Australia in 2012.
As recently as 2018, the FDA still found sibutramine in over 700 diet supplements marketed as "natural", "traditional", or "herbal remedies". These products are often sold online and falsely marketed as "herbal" or "all-natural," luring consumers who are looking for weight loss solutions.
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Frequently asked questions
Diet pills that have been found to contain sibutramine include counterfeit versions of Alli, Slimming Beauty Bitter Orange Slimming Capsules, Payouji tea, Pai You Guo Slim Capsules, Fruta Planta, and Venom Hyperdrive 3.0.
Sibutramine is a weight loss agent that was withdrawn from the market in several countries including the USA, Canada, the UK, and the European Union in 2010 because it was found to increase adverse events in patients with cardiovascular diseases. It has also been associated with an increased risk of non-fatal myocardial infarction and non-fatal stroke.
The US Food and Drug Administration (FDA) has issued warnings about several diet pills that have tested positive for sibutramine. Consumers should be cautious of products falsely marketed as "herbal" and "all-natural". It is also advised to be wary of purchasing weight loss pills online, as it is common for pills bought over the internet to contain sibutramine.
