Fentora Adverse Reactions

Summary of the safety profile: Typical opioid adverse reactions are to be expected with Fentora. Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose. However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be closely monitored for these.
The clinical studies of Fentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain. Therefore it is not possible to definitively separate the effects of Fentora alone.
Tabulated list of adverse reactions: The following adverse reactions have been reported with Fentora and/or other fentanyl-containing compounds during clinical studies and post marketing experience. Adverse reactions are listed as follows as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness: (See Table 2.)

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Description of selected adverse reactions: Tolerance, physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety and shivering have been observed in studies with Fentora.
Loss of consciousness and respiratory arrest have been observed in the context of overdose.
Hypersensitivity reactions have been reported in post-marketing experience, including rash, erythema, lip and face swelling, and urticaria.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Adverse Drug Reactions (ADR) Report Form of the Drug Office of the Department of Health.