Regulators Assess Anti-Smoking Drug Champix

According to trial data, 44 per cent of Champix patients stopped smoking after 3 monthsPfizer's anti-smoking drug Champix has come under scrutiny after the emergence of accounts linking it to feelings of extreme depression. The Medicinal and Healthcare products Regulatory Agency is set to keep close watch over the situation after 839 instances were reported where the drug had generated adverse side effects. Of these, almost 50 involved feelings of depression - predominantly in patients with a history of psychiatric irregularities. A further 16 accounts detailed feelings of suicide.

US FDA Concerned about Champix

In recent days, the US Food and Drug Administration has highlighted its fears concerning the drug.

Champix or, generically, "varenicline", has been on the market since 2006.

Strangely, in operation, Champix acts to both stimulate and deactivate the brain's nicotinic receptors. It is believed that, when the receptor is stimulated, the effects of nicotine are replicated, thereby lessening cravings. Simultaneously, the drug stops a percentage of nicotine from attaching itself to the receptor.

44% of Champix Patients Stopped Smoking After 3 Months

Data from trials involving the drug indicates that 44 per cent of smokers prescribed Champix kicked the habit after three months. This compares to a figure of 18 per cent in respect of those provided with a placebo, and 30 per cent for patients taking bupropion - an alternative anti-smoking treatment.

Champix Connected to Sickness, Dizziness, Headaches, Fatigue, Vomiting

Champix was already associated with nausea; of the 839 reports made to the MHRA, a feeling of sickness featured in 183. Away from this, 52 reports described bizarre dreams, 49 focused on dizziness, 82, headaches, 37, fatigue and 67, vomiting.

The larger part of the depression cases reported involved patients with prior experience of psychiatric issues.

Champix is taken by up to 20,000 UK smokers.

The drug's maker, Pfizer, has stated the following:

"There is no scientific evidence establishing a causal relationship between varenicline and the post-marketing report events. Quitting smoking, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness."

Source - Pharmaceutical International's Health Reporter

Pharmaceutical News Index

RSS