The National Institute for Food and Drug Surveillance (Invima) from the Directorate of Medicines and Biological Products reported that they are carrying out investigations to establish what is causing the outbreak of the Burkholderia bacteria in several cities in the country.
The entity reiterated that due to the notification of these outbreaks of infections associated with health care by Burkholderia spp in Health Service Providing Institutions (IPS) in different regions of the country, Invima – in compliance with its institutional functions – accompanies the different entities in charge of the process of evaluating and concluding the situation.
The Burkholderia Cepacia bacteria is of environmental origin and has the ability to survive in various natural environments such as water, air and land, | Photo: Europa Press 2022
A first hypothesis that the entity contemplates is the relationship between an injectable medication and the possible outbreak. “Currently, the investigation process is being carried out in the entities that reported the outbreaks and possible hypotheses have been established, one of them is associated with a medication.
Given this risk, the entity coordinated the process of taking samples of the batches in question and to date the results on the quality specifications are awaited. “However, given the importance of the situation and while Invima has the results of the analytical tests, it is recommended that health institutions and professionals not administer units of the batches of the aforementioned medication, the above under article 578 of Law 9 of 1979″.
According to Invima, once the results of the samples are available, they will be informed of the health actions that may take place.
“Invima reiterates its commitment to public health and the safety of medicines in the country, and continues to work hand in hand with local health authorities to investigate and take the necessary measures if any risk to the population is identified.”
Invima official statement – Part 1. | Photo: Official statement from INVIMA
Invima official statement – Part 2. | Photo: Official statement from INVIMA
What is Burkholderia?
According to the American Academy of Pediatric, Burkholderia group organisms can cause infections that can be easily controlled, but they can also cause infections that can become complicated.
For example, it could cause severe lung infections in young people with cystic fibrosis or in children who have chronic diseases such as cancer. They could also cause pneumonia.
The Burkholderia Cepacia bacteria is of environmental origin and has the ability to survive in various natural environments such as water, air and land, as well as in specific environments, for example, in the production and packaging lines of the pharmaceutical industry, among others. .
The initial symptoms may be a very low-grade fever, which then progresses to much more complex conditions, such as pneumonia and other lung disorders.
The situation not only affects Colombia, reports of the Burkholderia bacteria have been known in several countries in America and has left more than 45 deaths in Chile.
Diario El Día reported that at the end of September the contamination of the Sanderson Laboratory by this microorganism was confirmed, which caused an intra-hospital infectious outbreak that is still active. The Institute of Public Health ordered the withdrawal of products from the market.
2023-10-28 22:10:28
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