10 Warnings and Cofepris Approvals in 2023 Authorizes HIV Drugs

2023 is coming to an end and Federal Commission for Protection against Health Risks (Coffeeprice) has issued several warnings this year about fraudulent medications and contaminated products.

He also endorsed some scientific advances in the treatment of patients with cancer or HIV.

Body health also collaborated in identifying irregular distributors drugs in Mexico and accelerated the process of ensuring the sale of psychiatric drugs in the country after months of shortages in pharmacies.

IN Aristegui News We list the 10 most important Cofepris resolutions adopted in 2023.

The import of a vector for the treatment of leukemia is permitted.

On February 21, Cofepris announced the approval. to the university clinic “Dr. Jose Eleuterio Gonzalez” Autonomous University of Nuevo Leon (UANL) permission to import the lentiviral vector into Mexico.

With this approval, an academic institution can test the safety of T-cell therapy using chimeric antigen receptorss (CAR-T therapy) in people with lymphoblastic leukemia.

Prohibits the use of injectable paracetamol.

Also in February, but on the 27th, the health authority announced a ban on the injectable paracetamol solution called Axapara.

At the time, Cofepris indicated that its warning came after it had decided cancel medical registration so that they can be disseminated and applied to the Mexican population once violations are identified. product”“It does not meet the requirements for sterility and leak testing, indicating a faulty container closure system (leaky product).”

Endorses the use of tesofensine for the treatment of obesity

Last March, the Cofepris New Molecules Committee evaluated the tesofensine molecule, receiving a positive opinion with expert commentary for its use in the treatment of obesity.

Tesofensine was originally used to treat Parkinson’s and Alzheimer’s diseases, but studies have proven the molecule’s effectiveness for weight loss.

Six illegal drug distributors identified

In May the agency discovered six new illegal distributors selling drugs against diseases such as cancer, heart problems and immunodeficiency syndromes.

The updated list includes RG Alta Especialidad establishments located in Monterrey, Nuevo Leon; Distributors of Dicza in Puebla, as well as Medijapa and Hemo Home in Guadalajara, Jalisco; None of those mentioned have an operational notice. Meanwhile, at Distribución Farmacéutica Yalesa in the State of Mexico and Fhety Laboratorios in Mexico City, Cofepris has specialized staff could not check their sanitary conditionsince one of the addresses corresponded to a house, and the other to an office.

Allows the use of medications to treat HIV

The following month, in June, the health authority said it had authorized the purchase of 149 medical supplies, including testing materials. using a new molecule for treatment HIV.

The report, covering the first half of June, reported the approval of 25 drugs, including efavirenz/lamivudine/tenofovir disoproxil fumarate, an HIV molecule and L-asparaginase. biotechnology for the treatment of acute lymphoid leukemia.

Approves drugs to treat breast cancer

That same month, Coffeepris registered a new drug for the treatment of breast cancer.

In particular, the use of a new molecule for the treatment of breast cancer was approved. In addition, eight clinical trials were approved. Of these, three cancer treatment protocols and one for the treatment of hepatitis B virus.

Contaminated Ice Cream Alert

A month later, the health department warned the public about what had happened. contamination of Soft Serve On The Go ice cream with bacteria Listeria monocytogenes.

Real Kosher Ice Cream has issued a voluntary recall of this brand of ice cream in the United States; however, some products were distributed in Mexico.

Warning about the use of “modeling substances” during plastic surgery

A few days later, he warned of the health risks associated with the use and application of non-absorbable or non-biodegradable “modeling substances” used during plastic surgery, aesthetic or reconstructive.

He pointed out that the accelerated increase in the number of minimally invasive surgical procedures that use simulants has led to the development pathologies called diseases by modeling or with the help of adjuvants, or iatrogenic allogenosis. Modeling disease is a pathology caused by the introduction of non-absorbable or non-biodegradable foreign substances for cosmetic purposes and represents a serious health problem.

Approves sale of Covid vaccines from Pfizer and Moderna

In early December, Cofepris approved the medical registration of the Pfizer and Moderna antiviral vaccines so they could be sold in Mexico. These pharmaceutical companiesmeets the requirements of quality, safety and efficiencyin the files submitted to this federal commission.”

The authority noted that This “world first” regulatory process was implemented in record time. “following a thorough technical analysis carried out by specialized staff of this health authority and an assessment of the clinical effectiveness of these biological vaccines at sessions of the Committee on New Molecules (CMN), which were made public for the first time.”

Warning about imported fruit contaminated with dangerous bacteria

The health authority reported on December 13 about possible exposure to the virus. Listeria monocytogenes bacteria in peaches, plums and nectarines from the HMC Farms brand.

For the same reason, HMC Group Marketing has already recalled these products from the US markets. Coffeeprice has issued a risk notice to warn the public that These products were imported into Mexico. from the USA between May 1 and November 15, 2023.

Source: Aristegui Noticias

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