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Serious controversy brewing: are Chantix and Champix safe?

This article was originally written in August 2006. Since then there has been mounting concern regarding varenicline’s safety. Due to a number of recent developments, this article’s safety discussion is presented in chronological order. Each underlined date is a link to the development’s online source.

May 10, 2006 - The FDA approves Chantix’s Patient Information Sheet. The “Sheet” warns users of five “common side effects”: nausea, changes in dreaming, constipation, gas, and vomiting. What it fails to alert patients to is the fact that varenicline’s “Full Prescribing Information” sheet lists 160 additional potential adverse events. But as pointed out in a TV news interview with Dr. Ponni Subbiah, a Pfizer employee, all 165 “aren’t necessarily associated with the drug, a causal association. It’s just they were reported in the trials.”

Additional Full Prescribing Information sheet adverse events listed include: (1) nightmares (2) headaches (3) dysgeusia a/k/a reduced sense of taste (4) somnolence a/k/a drowsiness (5) lethargy (6) fatigue/malaise/asthenia (7) rhinorrhea a/k/a runny nose (8) dyspnoea a/k/a difficulty breathing (9) upper respiratory tract disorder (10) rash (11) pruritis a/k/a itching (12) increased appetite (13) decreased appetite/anorexia (14) anemia (15) lymphadenopathy (16) luckocytosis (17) thrombocytopenia (18) splenomegaly a/k/a enlarged spleen (19) angina pectoris a/k/a chest pain (20) arrhythmia a/k/a irregular heart rate (21) bradycardia a/k/a heart rate less than 60 beats per minute (22) ventricular extrasystoles (23) myocardial infarction (24) palpitations (25) tachycardia (26) atrial fibrillation (27) cardiac flutter (28) coronary artery disease (29) cor pulmonale (30) acute coronary syndrome (31) tinnitus a/k/a ear ringing (32) vertigo (33) deafness (34) Meniere’s disease (35) thyroid gland disorders (36) conjunctivitis (37) dry eye (38) eye irritation (39) vision blurred (40) visual disturbance (41) eye pain (42) acquired night blindness (43) blindness transient (44) cataract subcapsular (45 sleep disorder (46) ocular vascular disorder (47) photophobia (48) vitreous floaters (49) diarrhea (50) gingivitis (51) dysphagia (52) enterocolitis (53) eructation (54) gastritis (55) gastrointestinal hemorrhage (56) mouth ulceration (57) esophagitis (58) gastric ulcer (59) intestinal obstruction (60) acute pancreatitis (61) chest pain (62) influenza like illness (63) edema a/k/a swelling (64) thirst (65) chest discomfort (66) chills (67) pyrexia a/k/a fever (68) gall bladder disorder (69) hypersensitivity (70) drug hypersensitivity (71) liver function test abnormal (72) weight increased (73) electrocardiogram abnormal (74) muscle enzyme increased (75) urine analysis abnormal (76) diabetes mellitus (77) hyperlipidemia (78) hypokalemia (79) hyperkalemia (80) hypoglycemia (81) arthralgia a/k/a joint pain (82) back pain (83) muscle cramp (84) musculoskeletal pain (85) myalgia a/k/a muscle pain (86) arthritis (87) osteoporosis (88) myositis a/k/a muscle inflammation (89) disturbance in attention (90) dizziness (91) sensory disturbance (92) amnesia (93) migraine (94) parosmia (95) psychomotor hyperactivity (96) restless legs syndrome (97) syncope a/k/a fainting (98) tremor (99) balance disorder (100) cerebrovascular accident a/k/a stroke (101) convulsion (102) dysarthria a/k/a motor speech disorder (103) facial palsy a/k/a facial drooping (104) mental impairment (105) multiple sclerosis (106) nystagmus a/k/a involuntary eye movement (107) psychomotor skills impaired (108) transient ischemic attack a/k/a mini stroke (109) visual field defect (110) anxiety (111) depression (112) emotional disorder (113) irritability (114) restlessness (115) aggression (116) agitation (117) disorientation (118) dissociation (119) decreased libido a/k/a reduced sexual desire (120) mood swings (121) abnormal thinking (122) bradyphrenia a/k/a slowed thought processes (123) euphoric mood (124) hallucination (125) psychotic disorder (126) suicidal ideation a/k/a suicidal thoughts (127) polyuria a/k/a excessive volume of urination (128) nephrolithiasis a/k/a forming kidney stones (129) nocturia a/k/a waking during the night to urinate (130) urine abnormality (131) urethral syndrome (132) acute renal failure a/k/a kidney failure or injury (133) urinary retention (134) menstral disorder (135) erectile dysfunction (136) sexual dysfunction (137) epistaxis a/k/a nose bleeding (138) respiratory disorders (139) asthma (140) pleurisy (141) pulmonary embolism (142) hyperhidrosis (143) acne (144) dermatitis (145) dry skin (146) eczema (147) erythema (148) psoriasis (149) urticaria (150) photosensitivity reaction (151) hot flush (152) hypertension (153) hypotension (154) peripheral ischemia (155) thrombosis (156) abdominal pain (157) dyspepsia a/k/a indigestion (158) gastroesophageal reflux disease (159) dry mouth and (160) insomnia.

Both Pfizer, on the Patient Information Sheet, and the FDA, at its website, could have easily advised smokers of the identity of groups included in and excluded from clinical studies, yet both chose to keep smokers in darkness. Instead of only revealing the five most common side effects, the Patient Information Sheet could have told readers of the existence of 160 additional known risk concerns and directed them to either examine the Full Prescribing Information sheet or online FDA documents to see a complete list.

There, potential users would have learned the actual odds of experiencing the most common side effects, but, again, only for the types of smokers included within the studies. They would have read that nausea was seen in 30% of users, insomnia in 18%, abnormal dreams in 13%, sleep disorder in 5%, nightmares in 1%, constipation in 8%, gas in 6% and vomiting in 5%.

They would also have noticed that Pfizer had classified all 165 potential side effects as either: (1) common; (2) frequent; (3) infrequent; or (4) rare. Although Pfizer’s Chantix website directs smokers to ask their doctor, “Is CHANTIX™ (varenicline) right for me,” the Full Prescribing Information sheet fails to provide physicians with the information needed to answer this critical question. The sheet both fails to advise physicians of the identity of all groups Pfizer intentionally excluded from its five clinical trials, or define critical terms such as “frequent,” “infrequent” and “rare.”

Although the Prescribing sheet advised doctors that the five most common side effects (nausea, sleep disturbance, constipation, flatulence and vomiting) were experienced by greater than 5% of varenicline users, and that 19 other side effects listed as “common” occurred in greater than 1% of 1mg Chantix users, the terms “frequent,” “infrequent” and “rare” are not defined. All physicians are told is that these events reflect “a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials,” which, the sheet indicates was “over 4,500 individuals.”

It’s as if Pfizer is toying with physicians, leaving clues here and there. For example, if your doctor had read the bottom of a September 18, 2007 Dallas Morning News story, Pfizer would have revealed to her or him that adverse events reported as “infrequent” occurred at a rate somewhere between 1 in 100 and 1 in 1,000 patients.

This would seem to suggest that “frequent” would be more often than in 1 in 100 patients and “rare” less than 1 in 1,000 patients. But if “frequent” is defined as events occurring more often that 1 in 100, where do “common” events fit into the puzzle? Nearly all physicians attempting to analyze and properly advise patients regarding varenicline’s risk puzzle are clearly left guessing as to how often adverse events should be expected, which among the 165 listed are actually caused by Chantix or Champix, and how their patient’s chronic medical condition, and medications prescribed to treat it, will mesh with varenicline use.

October 4, 2006 - On this date a Chantix user named Suzy posted to a message board at WrongDiagnosis.com complaining of significant joint and muscle pain which started three days after she started taking Chantix and continued long after its use ended. Suzy closed by asking, “has anyone else experienced this?” Suzy had received 1,010 responses as of April 23, 2008, many documenting Chantix muscle and joint pain nightmares significantly worse than hers.

June 1, 2007 - On this date a physician named Antonio Howell, MD began replying to Chantix user comments to his blog, a blog in which he listed the psychiatric disorders mentioned on Chantix’s Full Prescribing Information sheet: “Frequent: Anxiety, Depression, Emotional disorder, Irritability, Restlessness. Infrequent: Aggression, Agitation, Disorientation, Dissociation, Libido decreased, Mood swings, Thinking abnormal. Rare: Bradyphrenia, Euphoric mood, Hallucination, Psychotic disorder, Suicidal ideation.”

On June 1, 2007, Deanna told Dr. Howell how her husband had never had any mental health problems but tried to take his own life after being on Chantix for 13 days. On August 27, 2007 Zezrie wrote Dr. Howell telling him how her brother-in-law shot and killed himself while on Chantix. Since then Dr. Howell has been overwhelmed by additional mental health horror stories. He recently started a poll asking visitors if Chantix should be taken off the market until additional safety studies are done. As of December 2, 2007, 70% responding said “yes” (38 of 56).

September 18, 2007 - A Dallas Morning News story reports on the Labor Day death of Carter Albrecht, a local musician who mixed heavy alcohol use (3 times the Texas legal driving limit, a fact first reported on October 22, 2007) with Chantix use, became delusional, aggressive, assaulted his girlfriend, and minutes later was “shot and killed breaking into a neighbor’s house.”

A statement by Pfizer attached to the bottom of the Carter Albrecht story seems to blame his death on the act of quitting, not varenicline. Pfizer asserts, “It is important to note that a vast body of medical literature has shown that smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illnesses.”

Before accepting Pfizer’s contention (which the FDA now appears to be buying into hook, line and sinker) we’d be wise to ask ourselves, with more than 46.5 million Americans having already successfully quit smoking, and CDC data indicating that almost 90% quit cold turkey, how many news stories have any of us ever read in which quitting cold turkey (without using any pharmacology product) was blamed for someone committing suicide, hallucinating, developing a psychotic disorder, horrible muscle or joint pain, or during which the quitter vomited for twelve straight weeks? Any?

September 24, 2007 - CBS 11 News in Dallas/Fort Worth broadcasts a story entitled “Miracle Drug or Dangerous Problem” (click link to watch the video clip). It reports on Carter Albrecht’s death. It also pictures Karen from Maryland and Deborah in Oregon who both felt suicidal while using Chantix, and Candace in Arizona who experienced aggression. It interviews Scott Mullins who experienced bad dreams and horrible thoughts. “As much as I hate to admit it,” says Scott, “there have been times that I thought about ending my life.”

September 2007 - Public Citizen, a nonprofit, nonpartisan group which champions U.S. consumer interest, placed varenicline on its worst pills list, recommending that consumers not use it until 2014. Public Citizen cites varenicline’s common side-effects being reported by more than one-third of clinical trial users and contends that safety information is currently inadequate.

October 25, 2007 - CBS 11 News in Dallas broadcasts a second story entitled “Drugs Tested on Few Before Released to Masses.” It questions how Chantix could be approved for use after testing upon only 4,500 smokers. In it, CBS 11 News claims to have accessed the U.S. Food and Drug Administration (FDA) side effects data base and found “thousands of similar and very serious reactions to Chantix.”

It notes that Pfizer tested varenicline on roughly 5,000 users prior to FDA approval and although its physician “Full Prescribing Information” sheet warns doctors of a potential risk of “suicidal ideation,” “aggression” and “nervous system disorders” that the only risks mentioned on Pfizer’s Patient Information sheet are the five most common side effects.

The CBS 11 story asserts that new signals have caused the European Commission on Human Medicines to put Champix on its list of “New Drugs Under Intensive Surveillance” and that it is now keeping a close eye on potential “suicidal thoughts and behaviour” in European patients prescribed Champix.

October 25, 2007 - Omer Jama, a popular 39 year-old UK television editor is found dead with his wrists slashed at his Bolton, England home, four weeks after starting Champix. According to his brother, “He’s got no history of depression and was never the sort of person you would see feeling sorry for himself.”

November 20, 2007 - The FDA announces that it “has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix.” It reports that “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” and that as soon as its “analysis is completed, FDA will communicate its conclusions and recommendations to the public.”

My question regarding the FDA’s 11/20/07 announcement is who actually wrote it, the FDA or Pfizer, and whose interests are being protected, Pfizer’s or the consumers? Why does the announcement fail to share the gravity of the situation by at minimum revealing the total number of suicides among U.S. Chantix users that have thus far been reported to the FDA? Is this fact a national secret?

Compare the actual language from a statement Pfizer had the Dallas Morning News attach to its Chantix suicide story on September 18, 2007, to the actual language contained in the FDA’s investigation announcement that was written 2 months and 2 days later. Then ask yourself, who authored the FDA announcement?

• 09/18/07 Pfizer Statement - “… smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illnesses”
• 11/20/07 FDA Announcement - “… smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness.”

According to a November 26, 2007 Chantix article, the Prescription Drug User Fee Act is a 1992 law that allows the FDA to bill pharmaceutical companies for the cost of approving their products, with the FDA estimating 2007 collections under the Act exceeding $259 million.

The article shares the insights of Dr. Sidney Wolfe, director of health research for Public Citizen. Dr. Wolfe indicates that the Act has resulted in a cultural shift at the FDA with quicker turnaround times and a more accommodating attitude toward drugmakers. “The (pharmaceutical) industry is viewed by some people in the FDA as ‘our client. ‘They’re paying our salaries.’ Twenty years ago, if a drug went through clinical trials and there were more serious questions, the attitude was, ‘Let’s do more studies.’” According to Dr. Wolfe, “‘Not anymore.’”

November 28, 2007 - A Texas television station announces it used the Freedom of Information Act to obtain “a computer disc … with 5,157 complaints, which were all filed in just one week after the News 8 report aired.” This report asserts that, “suicide was reported 55 times,” suicidal thoughts were mentioned in 199 cases, 417 people complained of depression and there were hundreds of mentions of anger, aggression, amnesia, hallucination and homicidal thoughts.

December 10, 2007 - Australia’s Therapeutic Goods Administration (TGA) announces that it has reviewed reports submitted to the US FDA and ordered Pfizer to issue “Dear Doctor” letters and amend the Champix product information sheet. The warning states, “there have been reports of depressed mood, agitation, changes in behaviour, suicidal ideation and suicide in patients attempting to quit smoking while taking Champix.” Sale of Champix is scheduled to commence in Australia on January 1, 2008.

December 14, 2007 - The European Medicines Agency (EMEA) announced that “updated warnings to doctors and patients are needed to increase awareness of cases of suicidal ideation and suicide attempts reported in patients using Champix (varenicline).”

January 18, 2008 - Pfizer announced that it had “updated the Chantix label in the U.S. to include a warning that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.”

January 18, 2008 - Pfizer updated the safety information section of its Chantix website to warn visitors that, “You should be aware that some patients have reported depressed mood, agitation, changes in behavior, suicidal thinking or behavior when attempting to quit smoking while taking CHANTIX. If you experience any of these symptoms, or if your family or caregiver observes these symptoms, please tell your doctor immediately.” “If you have ever had depression or other mental health problems, tell your doctor before taking CHANTIX. Quitting smoking, with or without CHANTIX, can result in nicotine withdrawal symptoms (such as depressed mood, agitation) or a worsening of underlying psychiatric illness, such as depression.”

January 18, 2008 - Pfizer revised the Patient Information sheet to include an extremely weak and watered-down warning that suggests that all quitters, including Chantix quitters, may experience suicidal thoughts. It reads, “Tell your doctor if you experience agitation, depressed mood or suicidal thoughts. These symptoms have been reported in patients trying to stop smoking with or without Chantix. It is not known if these symptoms are related to Chantix.”

Shockingly, the Patient Information sheet keeps hidden what Pfizer reveals to those having Internet access, to those visiting its Chantix website, that we are not just talking about suicidal “thoughts” but suicidal “behavior.” Also, Pfizer continues to suggest that a normal and expected risk factor of quitting smoking cold turkey — for those attempting to extend or save their lives — is that they actually do the opposite and think about killing themselves. We have 48 million comfortable ex-smokers in America. Where are the news stories sharing details about how quitting brings with it a risk of suicidal thoughts or behavior? We have more than 200 nicotine replacement therapy (NRT) studies that followed tens of thousands of quitters, that detail the side effects and risks experienced by each group within each study? Where are the NRT studies mentioning suicidal thoughts, suicide, aggressive behavior or psychotic events?

January 18, 2008 - Pfizer updated its Full Prescribing Information sheet to warn physicians abut “Neuropsychiatric Symptoms.” The warning reads, “Serious neuropsychiatric symptoms have occurred in patients being treated with CHANTIX. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke. All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking CHANTIX in the post-marketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established. Patients attempting to quit smoking with CHANTIX and their families and caregivers should be alerted about the need to monitor for these symptoms and to report such symptoms immediately to the patient’s healthcare provider.”

While Pfizer at last reveals to healthcare providers that varenicline use was never studied in psychiatric patients, it continues to keep them in darkness as to all other classes of patients who were excluded from clinical trials, for which varenicline risks were not studied and are still unknown, including all with clinically significant medical conditions and all abusing alcohol.

February 1, 2008 - The FDA announces “important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide.”

The FDA’s February 1, 2008 “Public Health Advisory” goes to the extreme of enlisting families of varenicline users to remain “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.”

February 10, 2008 - New York Magazine publishes “This is My Brain on Chantix,” a firsthand Chantix use account by Derek de Koff, a features writer, who after taking Chantix experienced vivid dreams, blackouts, hallucinations and contemplated suicide.

April 1, 2008 - The FDA release a new two and a half minute Chantix safety warning video clip that for the first time admits “links” to serious neuropsychiatric problems in users, including suicide.

April 2, 2008 - WhyQuit article expresses concerns over FDA video clip not advising users of the actual number of suicides and not sharing honest efficacy and effectiveness info needed to make informed use decisions.

April 3, 2008 - FDA pulls video clip. WhyQuit makes video pulled clip available for viewing. Public Citizen calls upon the FDA to issue a “black box” Chantix warning, a warning reserved for drugs linked to serious or life-threatening adverse events, the strongest warning the FDA can mandate.

May 7, 2008 - USHHS released updated tobacco treatment Guideline giving Chantix equal recommendation weight with NRT and Zyban. Interestingly, the Guideline recommends use of Chantix on PDF pages 5, 7, 25, 60 and 62 but waits until page 63 to first mention its association with suicide. The 25 member private-sector panel authoring the Guideline had significant pharmaceutical industry financial ties.

May 16, 2008 - The FDA announced a name change and updating of the “Patient Information” sheet, which is now referred to as a “Medication Guide,” and updating of the “Prescribing (labeling) Information” sheet, with an updated “Information for Healthcare Professionals” page. The Medication Guide moves patient notice regarding risks of changes in behavior, agitation, depressed mood, and suicidal thoughts or actions from the tail end of the 01/18/08 version to the front of the revised guide. But in the paragraph following the warning the FDA permits Pfizer to use the normal, temporary sense of emotional loss accompanying all cessation attempts, to water down the above warning by asserting, “When you try to quit smoking, with or without CHANTIX, you may have symptoms … including … depressed mood … irritability … anger …” The revised Prescribing sheet tells providers to advise patients to not only report behavioral symptoms but immediately stop taking Chantix.

May 21, 2008 - A media firestorm hits Chantix as an ISMP study is released examining 6,363 U.S. Food and Drug Administration adverse drug reaction reports implicating Pfizer’s quit smoking pill Chantix, and 3,063 are found to involve serious injuries, including 78 deaths, only 28 of which were from suicide. FDA is criticized for only focusing almost exclusively on behavioral death risks when numerous reports suggest cardiac causes, both thromboembolic and arrhythmic. It states that by the end of 2007 “varenicline accounted for more reports of serious drug adverse events in the United States than any other drug.” The study recommends in part that smokers “consider the use of alternative approaches to smoking cessation.”

May 21, 2008 - The Federal Aviation Administration banned pilots and air traffic controllers from using Chantix based upon the above ISMP study implicating Chantix in contributing to 173 serious accidental injuries.

May 22, 2008 - Impacting truckers and bus drivers, the Federal Motor Carrier Safety Administration announced that, “medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle.”

May 29, 2008 - Pfizer goes into damage control mode and purchases full-page Chantix ads in America’s 5 largest newspapers, including this ad from the New York Times.

Cessation pharmacology history has never before seen the frequency and severity of the adverse events now being attributed to Chantix and Champix, with many lingering long after its use ends, and some permanent or fatal. If varenicline’s “real-world” benefits (if any) do not significantly exceed the degree of risk it poses, times the probability of those risks occurring, it should not have been allowed on the market.

Today, no government can tell us if varenicline’s benefits exceed its risks as honest and quality studies that could have answered this question were not conducted prior to approving varenicline’s sale. Our current drug approval process is upside down, with governments catering to industry profit concerns instead of consumer safety and effectiveness.

When Zyban (bupropion) came on the market, smokers were provided extremely detailed information regarding its potential to trigger a seizure. It allowed us to make informed decisions. If Pfizer knows the actual odds of experiencing any “rare” yet significant side effect, does it have an obligation to share the actual odds with users? In regard to “frequent” and “infrequent” side effects, if Pfizer does not know the actual odds of experiencing those it has listed, should it? Are Chantix and Champix users, and their physicians, entitled to the relative-risk information needed in order to make informed and intelligent cessation decisions?

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