Cofepris increases restrictions on oxycodone medications

by time news

2023-11-07 23:00:40

To care for the health of the population, the Federal Commission for the Protection against Health Risks (Cofepris) announced a change for the oxycodone medications. This is an indication that manufacturers must strictly follow, but it also impacts pharmacies and medical personnel.

From now on, new regulatory actions will be taken for the marketing, prescription and supply of opioid medications such as oxycodone. The goal is to reduce the risk of addiction on the part of consumers.

What is oxycodone?

It is a drug that belongs to the family of opioids. It is usually used to treat moderate to severe pain. Despite its high effectiveness, one of the biggest problems is that it is highly addictive.

What is Opioid Use Disorder?

For its part, after an exhaustive risk analysis and the documentary study of national and international scientific information, it was concluded that there is a possibility that the consumption of drugs with oxicodona genus Topioid use scratch (TUO)that is, abuse, dependence and dependence syndrome towards said substance.

It also mentions that patients can develop sleep-related breathing disorders, which can manifest with dyspnea, bronchospasm, rhinitis, respiratory depression, among other symptoms.

They may also experience possible adverse reactions that include psychiatric, cardiovascular, renal and urinary disorders, as well as nausea, vomiting, constipation and dry mouth.

Cofepris increases regulations for oxycodone drugs

In Mexico, according to figures from the National Commission against Addictions (Conadic)there is an increase in hospital emergencies, hospitalizations and even deaths associated with the use of opiates in the last five years. A phenomenon that, in recent decades, has had a significant impact on the mortality of hundreds of thousands of people around the world.

Due to this problem and using prevention and control criteria, Cofepris has undertaken the following actions from the regulatory field:

Identification of products containing this type of substances registered with Cofepris and their regulatory status. Request to update current health records for medications with oxycodone, with the aim of incorporating a legend on their packaging that contains: “abuse of this medication can cause addiction.” Analysis of medications that, due to their physicochemical composition, can generate abuse or addiction, considering their epidemiological behavior in Mexico and other parts of the world. Implementation of measures and adjustments aimed at reducing the risk of abuse, which implies modifying the conditions of each health record. Surveillance to identify and sanction web pages, online sales platforms and social media accounts that promote and market these medicines, which belong to the section I of article 226 of the General Health Law.

In addition, Cofepris Calls on health professionals to carry out a correct and detailed assessment, as well as close monitoring of patients to whom it is prescribed and supplied. oxicodona. The goal is to prevent the development of OUD and other disorders. In addition to this, reports of adverse reactions caused by this substance are encouraged.

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