The new advice from the MHRA follows investigations in the US after a national outbreak of e-cigarette or vaping associated lung injury, where more than 2600 cases and 60 deaths have been reported.
As of January 2020, the MHRA has received a total of 244 suspected adverse reaction reports, of which 182 were respiratory related. Serious respiratory events including lipoid pneumonia, hypersensitivity pneumonitis, pulmonary fibrosis, pleural effusion, pneumothorax, lower respiratory tract infection, and infectious pneumonia were described in 20 of these reports.
The MHRA is currently aware of two potential cases of e-cigarette or vaping associated lung injury in the UK, both of which were reported as having fatal outcome.
Although the reports in the UK do not reflect the trends seen in the US, the MHRA is conducting surveillance to ensure they can identify any potential cases.
Healthcare professionals have been asked to have a high index of suspicion in patients presenting with respiratory symptoms where there is a history of e-cigarette use or vaping in the past 30 days.
'Routinely' question patients
In addition to being alert to possible cases of lung injury, clinicians are advised to routinely ask all patients about the use of e-cigarettes or vaping products as they would about traditional cigarette smoking. The brand and type of products being used, the duration and frequency of use and the strengths of substances used should be documented in the patient's medical record.
Based on expert advice, the MHRA has provided healthcare professionals with case definitions to aid identification of probable or possible cases of e-cigarette or vaping associated lung injury.
Cases should be reported as 'probable' if they meet all the following criteria:
- The patient has been using an e-cigarette or vaping for the last 30 days
- Pulmonary infiltrate, such as opacities on plain-film chest X-ray, or ground glass opacities on chest CT are seen
- Absence of respiratory infection
- No evidence of alternative diagnosis (eg, cardiac, autoimmune, malignancy)
Cases should be reported as ‘possible’ if all the criteria have been met but the patient either has a respiratory infection or testing for infection has not yet been carried out the clinical team believes the infection is not the only cause of the underlying lung injury.
Healthcare professionals are encouraged to use the Yellow Card Scheme website to report any suspected side effects or safety concerns with e-cigarettes or vaping liquids.
If cases of e-cigarette or vaping associated lung injury are reported, healthcare professionals must specify whether they are probable or possible cases and provide full details of products, vaping history and other potentially relevant clinical details.