Published: 16 August 2019

Safety Information

Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Cathejell Lignocaine 2% Gel and reports of issues when using this medicine

16 August 2019

Description

Products affected
Additional information
Regulator actions
Reporting
References

Medsafe has received reports of issues associated with the use of this medicine. These reports include:

• A rough edge at the top of the applicator that is uncomfortable for patients and could cause harm.
• Pain on insertion as the user found it difficult to create sufficient pressure to release the gel on insertion.
• The gel was painful causing a ‘stinging’ sensation.
• During insertion air bubbles can be introduced and there is potential to create a vacuum immediately following insertion.
• It is easy to spill the product, potentially resulting in an incomplete dose.
• The product requires training to ensure safe use, which is not currently available.

Products Affected

Cathejell Lignocaine 2% Gel

Cathejell Lignocaine 2% Gel is approved for surface anaesthesia and lubrication for:

• The male and female urethra during cystoscopy, catheterization, exploration by sound and other endourethral operations.
• Nasal and pharyngeal cavities in endoscopic procedures such as gastroscopy and bronchoscopy.
• Proctoscopy and rectoscopy.
• Tracheal intubation.
• Cytoscopy and symptomatic treatment of painful cystitis and urethritis.

The dose is dependent on the use and individual patient factors.

Additional Information

Cathejell Lignocaine 2% Gel is a Pharmacy Medicine. The company has not supplied either a Data Sheet or Consumer Medicine Information to Medsafe for publication. As the product is not a prescription medicine this is not a requirement.

Training in the use of the product has been proposed by the company and this is expected to commence shortly.

In some reported instances it is not clear whether the issue relates to user preference, inadequate information or training in use of the product, or with the product itself. Medsafe is seeking information from users of the product to assist its investigation. When reporting issues experienced with this medicine, we ask that the reporter be specific as to whether the issue relates to the lignocaine gel or the delivery device, and the consequences or outcome, if any.

Cathejell Lignocaine 2% Gel is funded by PHARMAC.

Regulator Actions

Medsafe is continuing to monitor the rate and pattern of occurrence of this issue.

Medsafe is continuing to monitor reports of adverse events to Cathejell Lignocaine 2% Gel.

Medsafe is investigating the reported issues, and is in contact with the New Zealand sponsor.

Reporting

Consumers and healthcare professionals are encouraged to report quality issues with medicines to Medsafe at recalls@health.govt.nz

Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).