- Prescribing Advice for GPs - https://www.prescriber.org.uk -

FDA issue fentanyl warning

The Food and Drugs Administration (FDA) has issued a public health advisory following reports of deaths and life threatening side effects in patients using fentanyl patches.

The FDA have made several recommendations including:

The Medicines and Healthcare products Regulatory Agency has also collected safety data (PDF) detailing side effects reported in patients using fentanyl products. Approximately 10% of all reactions reported were respiratory in nature. The data include 19 reports of bronchospasm, 19 reports of dyspnoea, 26 reports of respiratory depression with 1 fatal outcome and 4 reports of respiratory failure with 3 fatal outcomes.

Action: Clinicians and patients should be aware of the potential for life threatening side effects and the need to seek urgent medical attention should they occur.