FDA orders new label warnings over anaesthetics risk in children
pharmafile | December 19, 2016 | News story | Research and Development, Sales and Marketing |Â Â FDA, anaestheticsÂ
The FDA has announced a new Drug Safety Communication for label warnings on general anaesthetic and sedation products because of the potential effect their repeated use could have on pregnant women and children under three years old.
Knowledge in this area is thin and rife with caution; recent research has suggested that single or short-term exposure to these drugs has little if any adverse effects, but the association said further research is necessary to accurately understand the full effects that prolonged exposure can have.
The agency stated: “Based on FDA’s understanding of brain development, the data suggest that the fetuses of women in their third trimester of pregnancy and children younger than three years are most likely vulnerable to this effect.”
Findings have been consistent with animal studies which have shown that lengthy or repeated use can have negative effects, the first of which was conducted in 1999 and has paved the way for concurrent research into the danger of anaesthetics on brain development in very young children. This research has been funded through a partnership with the International Anesthesia Research Society (IARS) called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots).
Ultimately, the FDA has recommended that a balance is struck between the beneficial use of anaesthesia and its potential risks, especially across repeated procedures or in sessions lasting longer than three hours, suggesting a shared agreement is reached with parents, caregivers and pregnant women. This recommendation is required to be communicated through updated labelling of anaesthetic and sedative products.
Matt Fellows
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