2023-10-29 01:42:36
The National Institute for Food and Drug Surveillance (Invima) issued a warning regarding outbreaks associated with Burkholderia spp in Health Service Providing Institutions (IPS) throughout the national territory.
As reported by the Directorate of Medicines and Biological Products, one of the hypotheses of these outbreaks presented and notified are related to a medicine: “Therefore, Invima considers it necessary to warn regarding the medicine with health registration number INVIMA 2019M-0010014- R1, corresponding to the active ingredient Hydromorphone Hydrochloride 2mg/mL in injectable solution, lots HMF -074, HMF -075, HMF -80, HMF -81, HMF – 82 and manufacturer Laboratorios Ryan de Colombia SAS,” the statement reads. .
This bacteria is related to cystic fibrosis. | Photo: Getty Images
During the monitoring and investigation process, Invima managed the taking of samples from the batches – already described – to obtain results and suggest sanitary measures. However, it warns service-providing institutions not to manage these units, according to article 578 of Law 9 of 1979, which says:
“When non-compliance with the provisions of this Law results in risks to people’s health, this fact must be publicized to warn users,” it states.
In this way, it ensures that “Invima, in compliance with its institutional functions, accompanies the different entities in charge in the process of evaluating and concluding the situation,” he adds.
Invima is investigating the medications related to these outbreaks. | Photo: Getty Images
However, the regulatory entity comments that “once the results of the samples are obtained, they will be informed of the health actions that may take place”, all in order to protect their public health and the safety of the medications to take the measures. that reduce the risk of any health complications.
What is Burkholderia bacteria?
According to Codeinep, the Burkholderia genus is a group of saprophytic bacteria that feed on the nutrients found in the decomposition of dead organic matter, confirms the University of Navarra Clinic.
Within the Burkholderia cepacia complex are B. dolosa, B. anthina, B. pyrrosia and B. stabilis, among others, which can develop pneumonia, which in the words of the National Cancer Institute (NCI) is an infection that negatively affects the lungs causing pus in the air sacs (alveoli).
Even premature babies are affected by this bacteria | Photo: Getty Images
Likewise, and according to Healthy Children, this bacteria can spread from person to person, with hospitals being ideal places for its reproduction, which is why it suggests frequent hand washing and following the health measures of medical centers to reduce your risk.
Even the Academy of Pediatrics comments that Burkholderia infection also has an impact on cystic fibrosis or chronic granulomatous disease, also affecting premature babies.
It should be remembered that cystic fibrosis, according to the United States National Library of Medicine (MedlinePlus): “It is a disease that causes the accumulation of thick, sticky mucus in the lungs, digestive tract, and other areas of the body,” being a one of the most common lung diseases in young adults and children that, if not received medical attention, can be fatal. “Many people carry the CF gene, but do not show any symptoms,” he concludes.
1698547455
#Invima #investigates #outbreaks #Burkholderia #bacteria #present #institutions #providing #health #services