THE CASE
On 12/12/2007 I wrote about some psychiatric side effects of the anti-smoking drug varenicline marketed in Australia as Champix and in the US as Chantix. My complaint was that the Therapeutic Goods Administration (TGA) had allowed this new drug onto the market and the Pharmaceutical Benefits Advisory Commitee (PBAC) had approved it as a subsidised Pharmaceutical Benefits Scheme (PBS) medicine without the Consumer Medical Information (CMI) including the latest warnings about the possibility of serious psychiatric events.
see ANTI-SMOKING drug's serious side effects ignored
The FDA has just issued (01/02/2008) a Public Health Advisory on Chantix, the Agency asked the manufacturer to add some new safety warnings:
Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug's approval.Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.Patients should immediately report changes in mood and behavior to their doctor. Vivid, unusual, or strange dreams may occur while taking Chantix. Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.
Meanwhile according to press reports Pfizer is working with TGA on rewording the Australian warnings to mirror the US warnings. A quick check on the TGA web site today (11/02/2008) did not indicate that varenicline was a drug of interest to them.
MY VERDICT
Varenicline seems to be the most effective drug yet developed for aiding smoking cessation, but the merit of its efficacy does not absolve the manufacturers and authorities from making it use as safe as possible.
3 comments:
ricky said:
"It is really some good information about anti smoking. chantix or champix are good and it very effective also."
He then linked to a site selling Chantix.
Ricky you must be a Chantix Blogtroll, I have removed the link
Diego Luego
Joseph MG wrote
"It is very easy to quit smoking with smoking cessation drug as it helps you in many ways. If you buy chantix , it helps you by reducing withdrawal symptoms and curbing nicotine cravings and also you can quit smoking easily as it makes smoking displeasing. These benefits can be availed only if you buy chantix smoking cessation drug"
Joseph MG then gave a link to a Pfizer site selling chantix.
Dear Pfizer Blogtrolls,
I will not allow this site to be an advertising platform. I will NOT publish links promoting Internet drug sales. Medicines need to be taken under the supervision of doctors and pharmacists. Drugs are not an ordinary item of commerce like toilet paper or i-Pods.
.....and please lean to write grammatically correct English.
Diego Luego
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