According to the 8/4/10 edition of the Age in Melbourne, the Therapeutic Goods Administration (TGA), the requisite drug regulator in that country, is concerned over reports of hundreds of Australians considering suicide, 15 of which have reportedly been linked to the medication since 2008.
Since Champix was approved for Australia a little more than two years ago, there have been no fewer than 1,025 reports of adverse reactions to Champix. Among them, 206 "suicide-related events" and 15 actual suicides. Of the latter, 13 of the reported suicides were taking Champix exclusively as part of a smoking cessation attempt, and were not taking any other medication when they took their own lives.
Sixty-seven percent of the total adverse reactions reported to the TGA describe psychiatric symptoms such as depression, agitation, anxiety, altered mood and aggression.
There has emerged a debate in Australia between those who feel such a basket of adverse events warrants the removal of Champix and the TGA, which cites a lack of proof that Champix causes suicidal thoughts.
"Stopping smoking—with or without medication—may be associated with various psychiatric symptoms such as depressed mood [including suicidal ideation], irritability, anxiety and frustration, or anger; stopping smoking may also exacerbate any underlying psychiatric condition," said a spokesperson for the TGA, which has no current plans to limit the availability of Champix in Australia.
"There is significant information in the product and consumer information for varenicline [Champix] on the association between varenicline use and the development of suicidal ideation," said the spokesperson. "All medicines have potential risks. The TGA, as a regulator, has to consider the balance between the benefits offered by any medicine and the potential risks associated with its use. These risks and benefits also need to be considered when the medicine is prescribed."
READ MORE CHANTIX LEGAL NEWS
A spokesperson for Pfizer, the manufacturer of Champix (and Chantix in the US), acknowledged in the Age report that Champix could be causing adverse reactions in some patients. "Current evidence does not establish a causal link between Champix and these adverse events, but it cannot rule it out either."
About 9.5 million people, according to the report, are using Chantix / Champix worldwide—including more than a million in Australia.
READER COMMENTS
Tim O'Beirne
on
Rod Hamblin
on
I am trying to get a legal firm to take a class action.
I can be contacted on ark-3@bigpond.com
Regards
Rod
Rod Hamblin
on
I have suffered an “Adverse Reaction” to the medication “Champix by Pfizer & approved by the the TGA.
I have suffered heart arrhythmia, stroke, loss of sight in right eye & amputation of right big toe.
I have been fighting them for the past 662 days. I can’t get a Law firm to take them on or a Government department to help.
I have contacted 15 Commonwealth Departments including the Commonwealth Ombudsman & the Minister of Health. I am awaiting word from the Commonwealth Ombudsman, but they say they don't have to advise me of their findings.
CHAMPIX reported reactions to date
Number of cases with a single suspected medicine 1829
Number of cases where death was a reported outcome 40
I received a letter from Pfizer's Lawyers, DLA PIPER, New York on the 14th June,2016 refusing my claim for compensation for the health problems I have suffered from their clients product Champix.
In their 2nd last paragraph they state:-
“the 2014 package insert for Champix contained a warning as to possible serious
neuropsychiatric events including "'changes in behaviour, thinking or mood," "depression, anxiety,
agitation, feelings of aggression, mood swings," brought of self-harm or self-harm." The
pamphlet also noted "Worsening of these symptoms has also been reported in people who
already had mental health problems." In addition to providing warnings as to possible
psychotropic events, the pamphlet also provided warning of other very serious side effects,"
including "abnormal or fast heartbeat ." As such, Pfizer adequately warned of these potential
adverse events.”
This paragraph states that Warning was given prior to 2014, I believe it was made by the FDA in 2008-2009.
It wasn't made here in Australia by Pfizer until October 2015 or by the TGA until 15th December, 2015. Although the TGA were advised to order a “Black Box” warning in 2008 the same as other countries have done.
I am attaching 3 files
1. Pfizer letter stating that all adverse effects were known & documented prior to 2014 (see Files 160617 FROM PFIZER's LAWYERS).
2. Pfizer Australia advertised “Stop taking Champix and tell your doctor immediately if you or your family/friends notice any changes in your behaviour or thinking, if you become agitated or depressed, or have thoughts of self-harm.” This was advertised in October, 2015. (PFIZER CHAMPIX WARNING attached).
3. The TGA advertised “Safety advisory – risks of psychiatric symptoms and potential interaction with alcohol”. This was advertised on the 1st December 2015. (TGA CHAMPIX WARNING attached).
My allegation is that Pfizer Australia have ignored warnings from their parent company.
That the TGA have ignored warnings from 2008 until now.
That the ACSOM Committee members have another reason for permitting the sale of Champix, untested Medicine & missing the standard warnings issued by overseas countries.
Lisa Louden
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Lyn Roberts
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