27/07/2024

Suspension of sales of sibutramine products

HSA Suspends Sales of Sibutramine Products with Immediate Effect

The Health Sciences Authority (HSA) is suspending the sales of sibutramine products in Singapore with effect from 11 Oct 2010, after consulting its Pharmacovigilance Advisory Committee (PVAC) and a panel of external experts in metabolic diseases and cardiology. This decision was made following a benefit-risk assessment of sibutramine, which concluded that the increased cardiovascular risk of sibutramine outweighed the modest weight loss seen in patients. The deliberations have taken into consideration the findings from the Sibutramine Cardiovascular Outcomes (SCOUT) study, the use of the product locally, and developments in other international jurisdictions.

Sibutramine is licensed for use in Singapore since 2001 as an adjunctive therapy to diet and exercise for obesity and for overweight patients with obesity-related risk factors such as Type 2 diabetes or disorders in lipid metabolism. It is marketed under four different brands in Singapore - Reductil®, Ectiva®, Reduxade® (all by Abbott) and Slenfig® (Apotheca Marketing).

The SCOUT study was a large study designed to evaluate the cardiovascular (CV) safety after the long-term use of sibutramine in patients who had a history of CV disease and/or type 2 Diabetes Mellitus (DM) with at least one CV-related risk factor such as high blood pressure and high lipid levels. Approximately 10,000 patients who were overweight and obese, aged 55 years and older were recruited in the study and treated up to six years. This study has shown a moderate increased risk of serious CV events associated with sibutramine use in patients with pre-existing CV disease.


Banned weight loss substance that increases heart attack, stroke risk found in coffee sachets
V-SHOU Premium Coffee has been found to contain sibutramine

A prescription-only weight loss medicine that has been banned in Singapore since 2010 has been detected in a coffee product sold on various local e-commerce platforms, the Singapore Food Agency (SFA) said on Wednesday (Jul 24). 

Consumers are advised not to purchase or consume V-SHOU Premium Coffee as it contains sibutramine, a substance that is known to increase the risk of heart attack and stroke. Other serious health consequences reported with sibutramine's use include heart problems, central nervous system disorders such as psychosis and hallucinations, and seizures.

Marketed as a weight-loss product, V-SHOU Premium Coffee made several claims, such as accelerated fat burning, enhanced metabolism, quicker slimming results, as well as soothing the digestive system and controlling appetite. White kidney bean extract and hoodia gordonii, which has been touted as an appetite suppressant, are among its listed ingredients. The product's packaging does not state where it was formulated and its country of origin is unknown.


Banned weight loss substance that increases risk of heart attack, stroke found in coffee premix
ChoCo Premix Coffee has been found to contain sibutramine

Sibutramine, a weight loss substance banned in Singapore, has been detected in a food product sold on various local e-commerce platforms, the Singapore Food Agency (SFA) said on Monday (Jul 15).

Consumers are advised not to purchase or consume ChoCo Premix Coffee, which lists chocolate and hoodia gordonii extract among its ingredients. Hoodia gordonii has been touted as an appetite suppressant. Marketed as a weight loss product, ChoCo Premix Coffee made several claims, including weight loss, avoidance of muscle loss, acceleration of fat burning, fat removal, reduction in hunger, improvements in constipation, repair muscle and increase muscle mass. While the product's packaging says it is "formulated in USA", its country of origin is unknown and not listed.

"SFA has worked with various online e-commerce platforms to remove the listings of the product and issued warnings to the respective sellers to stop selling the product with immediate effect," said the agency. Sibutramine is a prescription-only weight loss medicine that has been banned in Singapore since 2010, due to an increased risk of heart attack and stroke. Other serious health consequences reported with its use include central nervous system disorders, such as psychosis and hallucinations, and heart problems. Seizures have also been reported with sibutramine.


HSA issues warning for 3 products containing banned weight loss medicine, steroids
The Health Sciences Authority has warned members of the public not to purchase or consume "‘LORENXO DELICIOUS PURE CHOCOLATE SUPPLEMENT" and "MOFA COFFEE".

Members of the public have been warned by the Health Sciences Authority (HSA) against buying several products that were found to contain "potent medicinal ingredients".

The products contain substances including erectile dysfunction medicine tadalafil, steroids and sibutramine, a substance banned in Singapore because of an increased risk of heart attacks and strokes. The affected products are: "LORENXO DELICIOUS PURE CHOCOLATE SUPPLEMENT", "DND Rx9" and "MOFA COFFEE". Two consumers developed adverse effects after taking the products, HSA said in a media release.

"LORENXO DELICIOUS PURE CHOCOLATE SUPPLEMENT" and "MOFA COFFEE" were sold on local online e-commerce and social media platforms including Carousell, Qoo10, Shopee and Facebook, said HSA. The authority added that it has worked with the platform adminstrators to remove the affected listings. It has also alerted its Malaysian counterpart to "DND Rx9" and "MOFA COFFEE", which were purchased or sourced from Malaysia.


HSA warns against two 'slimming products' after consumers suffer adverse effects
The Health Sciences Authority has warned the public not to purchase or consume ENRU PLUS+ and HKT HERBA KURUS TRADISI

The Health Sciences Authority (HSA) has warned members of the public against buying four products that were found to contain “potent medicinal ingredients”. These ingredients included sibutramine, a weight loss substance banned in Singapore, as well as erectile dysfunction medicine tadalafil and steroids.

The affected products are ENRU PLUS+, HKT HERBA KURUS TRADISI, PILL HUA LUO CIN TAN and Spinach GINSENG HERB SUGAR. ENRU PLUS+ and HKT HERBA KURUS TRADISI were marketed online as slimming products and carried labels claiming that they contained natural ingredients. They caused adverse effects such as breathlessness and heart palpitations in three women, said HSA.

All four products were sold on local e-commerce platforms such as Shopee, Lazada, Carousell and Qoo10 by sellers based in Singapore and Malaysia. ENRU PLUS+ was also marketed on Facebook. HSA said it has worked with platform administrators to remove the affected listings and issued warnings to the respective sellers. It also alerted its Malaysian counterpart about these four products, which were sold in Malaysia or by Malaysia-based sellers.


3 people suffer adverse effects after taking slimming products containing banned substance
Magic Mocha, Thao Moc Ho Tro Giam Beo Cenly and Cynthia Beauty EazyS Instant Coffee Powder

Three people suffered adverse effects such as palpitations and nausea after taking slimming products that contained the banned substance sibutramine, the Health Sciences Authority (HSA) said on Wednesday (Nov 10).

The products are Magic Mocha, Thao Moc Ho Tro Giam Beo Cenly and Cynthia Beauty EazyS Instant Coffee Powder. They were sold on e-commerce sites like Carousell, Lazada, Shopee and Qoo10 and social media platforms like Facebook and Instagram. "They were marketed with misleading claims which included 'fast-acting', 'fat-burning', 'reduce fat storage' and 'accelerate the breakdown of stubborn fat'," said HSA.

The authority said it has issued warnings to the sellers and platform administrators have since removed the affected listings. HSA said it received three reports from consumers who experienced palpitations, nausea, extreme thirst, migraine or dizziness after taking the products. An analysis of the slimming products showed that they contained sibutramine (banned since 2010), which can cause serious adverse effects.


Four Products Found to Contain Banned Substance Sibutramine; One Consumer Had Adverse Effects

The Health Sciences Authority (HSA) is alerting members of the public not to purchase or consume four products marketed online as weight loss products. Contrary to the ingredients listed on the packaging, HSA’s analysis of these products revealed that they contained the banned substance, sibutramine, which can cause serious adverse effects in consumers.

The four products are:
  • ‘Flash Slim’
  • ‘Leedee Botanical Beverage Mix Pineapple Juice Powder with African Mango’
  • ‘Quinn S Amyera’
  • ‘Schocolite Double Chocolate Cookies Drink with Hoodia Gordinii Extract and L-Carnitine’

The products were sold on local e-commerce and social media platforms. HSA has worked with the platform administrators to promptly remove the affected listings and issued warnings to the respective sellers.


Sibutramine

Sibutramine was withdrawn from the U.S. market in October 2010. Sibutramine affects chemicals in the brain that affect weight maintenance. Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure. Sibutramine may also be used for other purposes not listed in this medication guide.

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body. You should not take sibutramine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), if you are taking stimulant diet pills, or if you have a history of coronary artery disease, stroke, or heart disease.

Before taking sibutramine, tell your doctor if you have glaucoma, high blood pressure, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16. Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, cold or allergy medication, narcotic pain medicine, or migraine headache medicines. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.


Sibutramine

Sibutramine is a norepinephrine, serotonin and dopamine reuptake inhibitor indicated to assist with weight loss in obesity.

Sibutramine (trade name Meridia in the USA, Reductil in Europe and other countries), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is a centrally acting stimulant chemically related to amphetamines thus it is classified as a Schedule IV controlled substance in the United States.

In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.


Sibutramine

Sibutramine, formerly sold under the brand name Meridia among others, is an appetite suppressant which has been discontinued in many countries. It works as a serotonin–norepinephrine reuptake inhibitor similar to a tricyclic antidepressant. Until 2010, it was widely marketed and prescribed as an adjunct in the treatment of obesity along with diet and exercise.

It has been associated with increased cardiovascular diseases and strokes and has been withdrawn from the market in 2010 in several countries and regions including Australia, Canada, China, the European Union, Singapore, Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States. However, the drug remains available in some countries. Sibutramine was originally developed in 1988 by Boots in Nottingham, UK and manufactured and marketed by Abbott Laboratories and sold under a variety of brand names including Reductil, Meridia, Siredia, and Sibutrex before its withdrawal 2010 from most markets. It was classified as a Schedule IV controlled substance in the United States.

As of 2018, the FDA still found sibutramine in over 700 diet supplements marketed as "natural", "traditional" or "herbal remedies". Sibutramine has been used to produce appetite suppression for the purpose of attaining weight loss in the treatment of patients with obesity.