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BLOG: January 2008

Smoking meds: The Chantix story

The Chantix story - Chantix safety -
Chantix efficacy: studies and the real world

Considering medications to quit smoking? Many are trying to find their way out of the hard-to-brake habit with the help of drugs supposedly fighting nicotine addiction. As usual, benefits - if any - do come with a price tag in the form of adverse health effects. Often time, drug users are not even aware of their health problems being drug-related. Once in a while, random events bring specific drug-adverse-effect connection into the public spotlight, resulting in a flood of complaints - and lawsuits - from newly educated users.

Such is a story of the Chantix, a novel nicotine drug designed to help smokers quit smoking.

What makes this story more important than just making Chantix users aware of potential risks associated with it, is that it once again brings to attention dangerous, profit-morphed marketing practices of pharmaceutical companies, with the FDA all too often acting as an accomplice as long as (in)humanly possible. Hopefully, it will ultimately generate public outrage sufficient to enforce long due changes in how the U.S. drug market operates.

A detailed analysis of the facts surrounding Chantix is given at WhyQuit.com, by John R. Polito. Here are the main highlights.

It all started after Ryann Rathbone went public with her suspicion that the aggressive behavior of her musician boyfriend, Carter Albrecht, ultimately resulting in his violent death, was caused by his use of this smoking-cessation medication (Dallas Morning News, September 18, 2007). Within a week, over 5,000 complaints related to Chantix were filed with the FDA, including 55 suicide reports.

Why so many, all of a sudden? Didn't these Chantix users know before that there are specific Chantix' adverse effects possible? Turns out - they did not.

Chantix side effects

When the FDA approved Chantix (varenicline) for the treatment of smoking addiction, on May 11th 2006, the manufacturer, Pfizer, Inc., only listed 5 common side effects for this drug: nausea, abnormal(?) dreams, constipation, gas, and vomiting. The rest of 160 adverse health effects reported in pre-marketing trials were buried in Chantix' "Full Prescription Information sheet". Only those categorized as "frequent" - which is not specifically defined but seems to imply greater than 1% incidence - number in at 28:

Diarrhea...Gingivitis...Chest pain...Influenza like illness...Edema, Thirst...Liver function test abnormal...Weight increase...Arthralgia... Back pain...Muscle cramp...Musculoskeletal pain...Myalgia...Disturbance in attention...Dizziness...Sensory disturbance...Anxiety, Depression...Emotional disorder...Irritability... Restlessness...Polyuria...Menstrual disorder...Epistaxis...Respiratory disorders...Hyperhidrosis...Hot flushes and Hypertension.

"Infrequent" adverse effects of Chantix - again, not specified, but according to Pfizer's related writings, likely to be in the 0.1% to 1% incidence range - include Anemia, Angina pectoris, Arrhythmia, Myocardial infarction, Tachycardia, Thyroid gland disorders, Conjunctivitis, Eye irritation, Visual disturbance, Eye pain, Gastrointestinal hemorrhage, Mouth ulceration, Esophagitis, Gall bladder disorder, Diabetes mellitus, Hyperlipidemia, Hypokalemia, Arthritis, Osteoporosis, Amnesia, Migraine, Psychomotor hyperactivity, Restless legs syndrome, Tremor, Aggression, Agitation, Disorientation, Libido decreased, Mood swings, Thinking abnormal, Nephrolithiasis, Nocturia, Urine abnormality, Erectile dysfunction, Asthma, Dermatitis, Psoriasis, Urticaria, Hypotension, Peripheral ischemia and Thrombosis.

"Rare" adverse effects include renal failure, pulmonary embolism, psychotic disorder, suicidal ideation (thoughts), Cerebrovascular accident (?), Convulsion, Mental impairment, Multiple sclerosis, Psychomotor skills impaired, Transient ischemic attack, Blindness transient, Deafness and Meniere's disease.

Now, this is a completely different pictures of Chantix' "safety" emerging, isn't it?

CONTINUES: Chantix' safety