Since this bulletin came out in June the withdrawal was challenged by one of the manufacturers.
Dextropropoxyphene is an opioid analgesic used to treat moderate to severe pain. In addition to expected opioid adverse effects, serious adverse drug reactions including hepatic reactions, hallucinations, abuse, withdrawal symptoms and cardiac conduction abnormalities have been reported with this agent. A change in the patient’s disease state, other medications, or a decrease in kidney function can greatly increase the risk for cardiac effects.
The Therapeutic Goods Administration (TGA) has completed their investigation into the cluster of severe local injection site reactions in March 2011 that continued into April 2011.
Advice was then given to not administer the second adult dose of Pneumovax 23.
The investigation has now completed. The TGA considers that the increased reports of local reactions was not batch related but due to two factors. (Pneumovax 23 does have known high rates of local reactions after a repeat dose.)
- the increased number of people having a repeat dose following the inclusion of Pneumovax 23 vaccine in the National Immunisation Program in 2005 with revaccination after five years
- the increased reporting that followed the publicity of the batch recall.
The TGA has now advised that revaccination:
- should not be given routinely to immunocompetent individuals (that is, those with a healthy immune system)
- should be considered for patients at a high risk of serious pneumococcal disease, provided that at least five years has passed since the previous dose of Pneumovax 23.
Note this now differs from the current Australian Immunisation Handbook (9th edition 2008).
A discussion I had today with the acting in-charge at Communicable Disease Control Directorate, Department of Health, Western Australia indicates the schedule will most likely remain unchanged for Indigenous Australians.
Until this is put to us in writing (Medical Cordinator CDC WA is on leave at present) continue to withhold the second Pneumovax 23 ADULT dose.