SWSLHD and Bowral's Health - 38

TGA knew of Fluvax side effects in 2009

20th Oct 2011 AAP   all articles by this author  - Medical Observer

THE TGA has admitted that it knew in 2009 that Fluvax caused higher rates of fever than other trivalent influenza brands but took no action as the side effects were mostly mild or moderate.

An article in the MJA online on Monday raised questions about the fact that data from trials that found a high rate of fever were not included in Fluvax product information in 2010  (MO, 17 October).

TGA national manager Dr Rohan Hammett was questioned at a Senate estimates committee hearing yesterday about adverse events in children receiving Fluvax in 2010, which led to the withdrawal of the vaccine.

Dr Hammett said the TGA was made aware in 2009 of findings from a published trial that 22.5% of toddlers younger than three experienced fever after being given Fluvax in 2005.

That figure jumped to 39.5% in 2006, but only the 2005 data was included in the 2010 Fluvax PI.

Dr Hammett said people were now using a "retrospective scope" to suggest the TGA should have picked up on the problem before the 2010 flu season.

"Indeed in those earlier clinical trials there were rates of fever for the Fluvax vaccine that were higher than some other comparable vaccines," he told the hearing.

"However... most of those fevers were mild and moderate and there was no sign of a febrile convulsion signal."

Dr Hammett said the TGA had written to CSL seeking “to gain a greater understanding of what they knew when".

"We haven't yet received a response," he said.

Liberal senator Concetta Fierravanti-Wells also quizzed the TGA about the US Food and Drug Administration’s concerns about CSL's manufacturing process, including its accusation of an "inadequate" examination of dark particles found in vaccines sold in the US.

"Why are we leaving it to the US FDA to identify deficiencies with CSL?" Senator Fierravanti-Wells said.

"Why isn't the TGA doing that?"

Dr Hammett said the TGA was currently auditing CSL on a monthly basis.

Tags: CSL, Fluvax, fevers, TGA, Senate Estimates

 

SSWAHS = SWSLHN and mental health in the Southern Highlands - 2

Mental health findings prompt call for Govt action

15th Mar 2011

Mark O’Brien all articles by this author

1 comment

NEW research revealing anxiety and depressive disorders as the leading cause of disability in young Australians has fuelled fresh calls for the Federal Government to deliver on its election pledge to make mental health a priority.

The study, published in the MJA, found disability prevalence rates increased by almost 50% from younger adolescence to young adulthood, with mental health identified as the most common factor.

According to the research, carried out by the University of Queensland, eating disorders made a “significant contribution” to mental disability in young women, while ADHD and autism caused more disability in younger adolescents than in older adolescents and young adults.

In response, the Mental Health Council of Australia has urged the Federal Government to fulfil its election commitment to “make mental health a major second term agenda”.

Council spokesperson Simon Tatz requested the government ensure appropriate attention be given to the disability-related effects of mental illness during discussions about a future no-fault disability care and support scheme.

“This latest research highlighting the impact of anxiety and depression in young people adds to the weight of evidence that government action is urgently needed to address the chronic under-funding in mental health services,” he said.

MJA 2011; 194:232-35

Comments:

asdcarer

29th Mar 2011
8:52am

The article does not mention that the number of children diagnosed with autism doubled since 2003 so the burden due to autism has increased substantially.
Nor does it mention that many in the health sector do not regard autism as a mental illness so is some places no treatment is offered and few services are available to address the burden of disease due to autism.
The Government should compare the burden of disease to the proportions of its spending and to the training effort in the health sector.