Saturday, June 15, 2024

Weight Loss Products Alert: COFEPRIS Warns Against Illegal Sibutramine Sales

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The Federal Commission for Protection against Health Risks (COFEPRIS) recently issued a critical public health alert focusing on the illegal marketing and distribution of weight loss products that contain sibutramine, specifically singling out a product marketed under the name Reductil. This alert is a key element of COFEPRIS’s broader initiative aimed at safeguarding public health by rigorously enforcing regulations against medical products that pose safety risks.

The announcement serves as a stern reminder of the government’s commitment to crack down on unauthorized and potentially hazardous health products that infiltrate the market. Sibutramine, once a common component in weight loss medications, has been banned due to its significant risk factors, including severe cardiovascular issues. The fact that it continues to be distributed underscores the challenges regulatory bodies face in controlling the spread of unapproved drugs.

COFEPRIS’s action highlights the agency’s dedication to preventing the distribution and sale of illicit pharmaceuticals that can endanger consumer health. This announcement is part of a comprehensive strategy to ensure that all medical products available in the market conform to established safety and efficacy standards. By targeting illegal activities such as the sale of Reductil and other sibutramine-containing weight loss products, COFEPRIS aims to eliminate unsafe practices and enhance the overall well-being of the population.

COFEPRIS Reinforces Public Health Protections Against Illegal Weight Loss Products

Through its vigilant monitoring and enforcement actions, COFEPRIS continues to strengthen the regulatory framework and enforce compliance, reinforcing its role as a guardian of public health in the face of growing challenges posed by the illegal drug market.

Sibutramine was once widely used in various weight loss products but has been banned since 2010 due to significant health risks. This substance can cause a considerable increase in blood pressure and heart rate, which could pose severe risks to patients with a history of cardiac issues, such as heart disease, heart failure, arrhythmias, or strokes. The health dangers associated with sibutramine led to its prohibition by major health authorities around the world, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

COFEPRIS has been informed by Novo Nordisk México that Reductil, a product advertised as containing sibutramine, is neither manufactured nor distributed by them and is being sold illegally, particularly through social networks. The alert emphasizes that Reductil and any weight loss products containing sibutramine violate current health legislation, making their sale, distribution, and advertising illegal.

Weight Loss Products

COFEPRIS Warns Against Purchasing Illegal Weight Loss Products and Urges Public Vigilance

COFEPRIS strongly advises the public not to purchase Reductil or any weight loss products. It encourages anyone with information about the marketing or distribution of such products to report it through the official health complaint channels provided by the agency. In light of the risks associated with unauthorized weight loss products, COFEPRIS recommends that individuals looking to lose weight should consult with specialized medical professionals. Qualified doctors can provide a proper assessment and recommend safe and effective treatments based on individual health needs and conditions.

COFEPRIS continues to monitor the market and will provide additional information if new evidence arises about other weight loss products, companies, or establishments violating health legislation. The goal is to prevent the distribution of unsafe health products that could endanger public health.

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This alert serves strictly for dissemination purposes and is aimed at the general population. It does not constitute a resolution that authorizes, extends, or revokes health authorizations or represents a definitive statement involving the imposition of administrative sanctions or preventive or corrective safety measures.


Resource: Gobierno De Mexico, May 15, 2024

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