Early this month the US FDA approved changes to the warnings and precautions section on Gardasil® labels. The new information highlights the risk of syncope (fainting) and physical injuries resulting from associated falls. Tonic-clonic (jerking) or seizure-like movements have also been associated with syncope. The label changes are a reminder for health practitioners to remember precautionary actions; keeping patients under close observation, and if needed lying down, after vaccination. Such precautionary actions are of course already adhered to in the New Zealand HPV programme. The following key points may be interest:
• Syncope (fainting) is a common reaction to any vaccination, not just Gardasil®, and is described in the New Zealand data sheet for Gardasil®.
• Syncope also occurs in a wide range of contexts such as after venesection, blood donation or in response to pain.
• Syncope is seen more commonly in adolescents than other age groups.
• Signs and symptoms associated with syncope are: paleness, sweating, dizziness, ringing in the ears, or vision changes.
• Syncope is short lasting and the patient should be placed in the recovery position or supine to promote blood flow to the brain.
• Syncope can sometimes cause jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but this is not a diagnosis of epilepsy.
In The Unites States, the Vaccine Event Adverse Reporting System (VAERS) identified that around 13% of all Gardasil® related events were related to syncope. The percentage is similar to reports of syncope for other adolescent vaccines.
Data from New Zealand’s Centre for Adverse Reaction Monitoring (CARM) reported 18% of Gardasil® related events were related to vasovagal/fainting (ie syncopal events).
Gardasil® has not been withdrawn from any markets and is recommended on immunisation schedules in more than 100 countries. If the US FDA had serious concerns about the vaccine, it would not be recommended. The opinion of the US CDC and FDA in regards to Gardasil® continues to be that the benefits to the vaccine outweigh the risks.
In New Zealand, Medsafe assesses the data about adverse event reports in relation to Gardasil® on an ongoing basis and considers that the potential benefits of the vaccine continue to outweigh the risks of vaccination.
Theo Brandt,
Communications Manager, Immunisation Advisory Centre.
| 
