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Author Topic: Bid to expand warning on Champix anti-smoking drugs rubbished  (Read 9975 times)

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taken from http://www.heraldsun.com.au/news/victoria/bid-to-expand-warning-on-champix-anti-smoking-drugs-rubbished/story-fnpp4dl6-1227437478951 by LUCIE VAN DEN BERG, BRIGID O’CONNELL HERALD SUN JULY 10, 2015.

Bid to expand warning on Champix anti-smoking drugs rubbished

CALLS to overhaul warnings on a popular anti-smoking medication have been extinguished by the peak doctors’ body and national medicines watchdog.

More than 47,000 people have signed an online petition calling for explicit safety warnings on the controversial drug Champix, after it was linked to suicides and self-harming.

It comes as lawyers say a class action similar to one mounted in the US could be on the cards in Australia.

The Queensland coroner is reviewing all suicides where a person took the drug, after reopening the case of Timothy Oldham, 22, who killed himself days after starting to use it.

His mother Phoebe Morwood-Oldham believes Champix was to blame and wants Australia to follow the lead of the US and put a black-box warning label on packaging.

New warnings are unnecessary according to the AMA but AMA Victoria President and GP Dr Tony Bartone, said beefed-up warnings were a “poor second alternative” to discussing potential side effects with a doctor.

“A label could create more harm than good,” Dr Bartone said.

“It would scare off a lot of people unnecessarily who have had an informed conversation with their doctor.

He said patients should be informed about the potentials for reactions and side-effects that include significant agitation, sleep disturbance, even perhaps suicidal thoughts.

Although the risks were small, they needed to be monitored.

A spokeswoman for the Therapeutic Goods Administration said it continually reviewed adverse events and believed the leaflets provided about the product contained the appropriate information.

There were 2.7 million scripts written for the drug in Australia between 2008 and 2014.

During the same period the medicine’s watchdog received 23 reports of suicides where the patient was taking the drug when they died.

A spokesman for Pfizer, Lee Davelaar, said the company regularly reviewed safety data, with any changes to product information made in discussion with the TGA.

But Shine Lawyers Partner Roger Singh said the indications were that the drug was known to be hazardous to health and users were not adequately notified of this.

“This could potentially lay the foundations for a class ­action by users and families.”

Comments on the petition include Victorians who claim their mood and behaviour changed when they started the medication. “Rebecca” wrote that a friend with no history of mental health issues was taken to hospital with suicidal thoughts a week after starting the medication. She wrote: “Before he could say anything, the doctor asked him: ‘You’re not on Champix, are you?’ ”

(Note - Australian Contacts are: Lifeline Australia: 13 11 14 or lifeline.org.au, or Beyondblue: 1300 22 4636)
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