ANTI-SMOKING drug's serious side effects ignored

THE CASE

Is anybody awake in the Therapeutic Goods Administration (TGA) or the Pharmaceutical Benefits Advisory Committee (PBAC)?

On 01/01/2008 the anti-smoking drug varenicline marketed by Pfizer in Australia as Champix and in the US as Chantix will become available as a subsidised benefit on the Australian Pharmaceutical Benefits Scheme (PBS).

But on 20/11/2007 the US Food and Drug Administration (FDA) issued the following warning:

"FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking. Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them."

The problem is that this adverse information about varenicline (Champix) is not yet included in the notes of the Australian Schedule of Pharmaceutical Benefits and neither will it carry a warning similar to this:

"FDA recommends the following:

• Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
• Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
• Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them."

Why is this warning not included yet? The FDA information is in a freely available public document. Why has Pfizer not behaved like a good corporate citizen and insisted that this warning to be included?

"FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request."

If the case was so highly publicised, why were our drug monitoring watch-dogs so slow to circulate the details? Or are they just keeping them quiet? Do we have to wait for deaths in Australia too?

The officially sanctioned patient drug information, called a CMI, warns against driving and operating machinery, but so far does not mention these potentially serious mood changes.

To be fair the TGA has indicated that it will publish a warning for varenicline, but a search of the website today (19/12/2007) did not locate one so far.

MY VERDICT

This is undoubtedly a valuable drug in the fight against nicotine addiction. My complaint is that healthcare professionals, doctors and pharmacists, have not yet been informed of the latest side effects. The current patient's CMI for this drug is no help either.

As I have written is a previous article, I think that the TGA and most of the other health regulatory authorities need a jolly good spring cleaning.