Champix Success Rate - 25%

I do treat many people who have tried Champix (varenicline).  I do not hear many good stories about the drug with unusual dreams, nausea and depression being a very common complaint.  Pfizer, the world's largest pharmaceutical company, manufactures this drug.  How well is this drug marketed?  Worldwide sales of Champix were $755 million last year alone.  But what of the adverse effects?

Here are some interesting stats.  The Institute for Safe Medicine Practices (ISMP), a non profit agency that regularly measures the FDA's adverse event database found that these reports for Champix outnumbered reports for other meds, including opioids and chemotherapy agents, which are known to be toxic.  In fact, the ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly as suicides within 15 days as required. Instead, the drug maker apparently coded the suicides as “expected adverse events” among 26,000 such events, and added these to a quarterly periodic report, which is how less important, non-serious side effects are sent to the FDA.  So think about this a minute.  Does this mean Pfizer thinks that 150 suicides are an "expected event"?

Additionally the ISMP found that among the 6,363 adverse reactions blamed on Champix and reported to the FDA between May 2006 and December 2007, that 3,063 involved serious injury, including 78 deaths.  Another article focused on just one subset of serious Champix use reactions, mental injuries and serious behavioural incidents.  Among them were 227 reports of suicidal thoughts, acts or attempts, including 28 suicides, 397 cases of possible psychosis, 525 reports of hostility or aggression, 41 mentions of homicidal ideation (wanting to kill), 60 cases of paranoia and 55 cases of hallucination.

Another recent study found that Champix was 18 times more likely to be associated with violent behaviour than any of the other 484 drugs in the study – making it the worst offender of all in terms of aggressive reactions.

More recently serious cardiovascular problems have been reported which may spell the end for Champix as it does for many drugs.  Remember Vioxx?  Please take the time to read the accompanying blog post about the heart concerns that have been raised about Champix, I think you will be surprised!

Below are the side effects from the product insert.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• appetite changes
• changes in taste
• constipation
• dizziness
• drowsiness
• dry mouth
• flatulence (passing gas)
• gingivitis
• headache
• heartburn
• nausea
• rash
• sleep disturbance (difficulty sleeping or abnormal dreams)
• unusual tiredness or weakness
• vomiting

Check with your doctor as soon as possible if any of the following side effects occur:

• changes in behaviour
• changes in mood
• depression
• thinking about harming self or others

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of a serious allergic reaction (e.g., puffy, swollen eyelids, lips, tongue, throat, hands or feet; hives; shortness of breath; or a severe skin rash with peeling and blistering, possibly with headache, fever, coughing, or pain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.