Cofepris cancels registration to Redotex and generates debate among doctors

2023-05-19 01:00:52

• Cofepris decided to cancel the sanitary registration of Redotex and Redotex NF because they contain harmful substances and constant complaints from consumers.
• Among the adverse reactions that cause and can be lethal are tachycardia, involvement of heart valves and pulmonary hypertension, heart rhythm disturbances, as well as anxiety, nervousness and insomnia, among others.
• Both drugs are often used against obesity because they suppress appetite.

The Federal Commission for the Protection against Sanitary Risks (Cofepris) announced the revocation of the sanitary registries of the medicines Redotex and Redotex NF. The decision was made after the team of scientists from this health authority determined that its consumption represents a high risk to health, derived from the number of adverse reactions recorded and the harmful substances they contain.

Therefore, it is reported that as of today the production, distribution and sale of the products is suspended throughout Mexico. Redotex y Redotex NF. In this sense, the owner of the sanitary records is the company Products Medix SA de CV, Therefore, said actions represent a crime.

Why did Cofepris cancel the registration of Redotex?

Both products were used as obesity treatment, since they suppressed the appetite. However, this health authority carried out a review and technical analysis, identifying various adverse reactions that can be lethal, such as tachycardia, involvement of heart valves and pulmonary hypertension, heart rhythm disturbances, as well as anxiety, nervousness and insomnia, among others.

Both products contain D-norpseudoefedrinaa substance designed by the manufacturer to mask pseudoephedrine, banned in Mexico since 2008. It should be noted that prolonged use of D-norpseudoephedrine increases the risk of brain bleeding, heart damage, postpartum psychiatric disorders, exacerbation of glaucoma, urinary retention, insomnia, dizziness and nervousness.

Other substances contained in the formulation, such as triiodothyronine, diazepam, atropine and aloin, when combined can cause thyroid dysfunction, cardiac arrhythmias, strokes, fever, hallucinations and delirium, to name a few.

Reports of adverse reactions in other countries

Thanks to adequate pharmacovigilance, detected 837 reports of adverse reactions caused by the consumption of Redotex and Redotex NF. It is also known that the regulatory agencies of the European Union (1997), Russia (1998), the United States (2011), Argentina (2013), El Salvador (2013) and the World Anti-Doping Agency canceled the health records of Redotex and / or D-norpseudophedrine.

The permanence of these products in the Mexican market for more than 24 years can only be explained from the existence of a network that most likely involves former public officials from previous six-year terms. Therefore, part of the strategy that Cofepris will follow will be to further investigate said collusion network.

For what is described here, this federal commission recommends that the population not acquire or consume Redotex and Redotex NF. Likewise, it urges to go to health professionals for medical evaluation and to determine the alternatives for treatment and control of obesity.

If you have consumed any of the aforementioned products or present any adverse reaction or discomfort, it is necessary report it in the following link or by email: [e-mail]

Cofepris recommends that health professionals avoid prescribing both drugs and any other product containing D-norpseudoephedrine, as well as considering other therapeutic alternatives. As for distributors and pharmacies, a call is made to stop marketing immediately.

Also read:

Miracle! Cofepris authorizes the first clinical trial of a drug against MPOX (monkey smallpox)

Cuban vaccine Abdala receives a favorable opinion from the Cofepris CMN for its application in children

Cofepris authorizes 69 batches of psychiatric medications: From Clonazepam to Methylphenidate