Freedom of Information request on the recommendation of Fentanyl patches to add a conrtaindication to the SmPC (FOI 22/642)
Published 27 March 2023
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FOI 22/642
13th May 2022
Dear,
CHM recommended a contraindication for Fentanyl in opioid naïve patients in the treatment of non-cancer pain following the advice of the Opioid Expert Working Group (EWG), 2019. This advice was endorsed by CHM at their September meeting 2019.
MAHs for fentanyl products were informed of this recommendation in December 2019. I have attached the circulated letter for information.
As many of the MAs were authorised through European procedures, the MHRA has been working to get agreement with the lead member states (LMS) to facilitate the introduction of this contraindication. We would like to stress that the findings of the opioids EWG and the subsequent recommendations of CHM, came as a result of a review of safety information across the UK only, and are applicable as UK specific warnings. We are aware that the opioids safety picture may differ between EU countries, however, the EU recognise that Fentanyl is an extremely potent opioid which has a significant risk of harm in opioid naïve patients. Whilst 5 EU licences specifically replicate the CHM contraindication in opioid-naïve patients, others will contraindicate use in the treatment of “Acute or postoperative pain, because there is no opportunity for dose titration during short-term use and because serious or life-threatening hypoventilation could result.”
CMDh was made aware of our review and CHM recommendations. Unfortunately, updates adopted by PRAC and CHMP have been slow as the issue of dependence and addiction to opioids, is only being reviewed through PSURs of the individual opioids. In the most recent PSUSA (January 2021) for fentanyl transmucosal products, the LMS (FR) recommended that the outer packaging should have the warnings “Contains opioid – can cause addiction. This product should only be used for cancer pain control as prescribed in patients already taking opioids. Inappropriate or accidental use can be fatal”. The AR also recommends that these warnings should be extended to all transdermal patch products. However in the UK, fentanyl patches are also authorised for the treatment of chronic pain and hence the shorter CHM recommended label warnings are more applicable. With the exception of 5 licences, the labels of each of the transdermal products have been updated with the warning “contains opioid – can cause addiction” in bold on the front face of the package holding the patches. The outstanding licences were authorised through Europe.
Unfortunately, during the PSUSA for fentanyl patches and injection solutions Dec 2021, the LMS (NL) did not agree to additional warnings on the label, although preferred a review of the potential effectiveness of such warnings.
We would like to stress that our findings are based on UK data, and therefore CHM recommended warnings are specific for UK products. We encourage MAHs to update their SmPCs with inclusion of the contraindication, in line with CHM recommendations, as UK specific.
Kind regards,
FOI Team