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Smoking Cessation Drugs Are More Lethal Than Smoking Itself

Learning to stop smoking is not easy. You cough. You fidget. You crave. All you want is a cigarette. Just one. You want to go back to the day that you started this process and live that day over. But these days, your doctor can offer you a lot more help in the form of smoking cessation drugs. Yes, that's right, they can even double your chance of quitting. There are just a few caveats, but no biggie. Besides increasing your hostility, agitation, depressed mood and suicidal thoughts, they'll also elevate your risk for other psychiatric disorders, not to mention bring down your gastrointestinal, metabolic, nervous, endocrine, immunological, renal, respiratory and cardiovascular systems. But hey, at least you'll quit smoking right?

The side effects from these drugs are so bad that The Food and Drug Administration (FDA) said that medications such as varenicline (Chantix) and bupropion (Zyban and generics) must now carry a "black box" warning that they can dramatically increase the risk of psychological side effects including serious neuropsychiatric symptoms such as serious suicidal thoughts which lead to attempted suicide.

Some side effects are so serious that they can easily be considered as more of a hazard to long-term health than smoking itself, especially due to the amount of body systems involved and the severity of psychiatric symptoms affected.

The "black box" warning means that the makers of these drugs must list side effects in any advertising and will not be able to air "reminder ads," which highlight a drug’s name but don’t mention the condition it treats. The warning won’t have an effect on "help-seeking ads," which mention a condition, but not drug names--like the one dissected in the AdWatch video below.



Gastrointestinal (GI) side effects have frequently included nausea (7.2% to 40%), flatulence (6% to 9%), constipation (5% to 8.5%), upper abdominal pain (2% to 7.7%), dry mouth (4% to 6%), abdominal pain (5%), dyspepsia (5%), vomiting (1% to 5%), and GI reflux disease (1%). Diarrhea, gingivitis, dysphagia, enterocolitis, eructation, gastritis, GI hemorrhage, mouth ulceration, esophagitis, gastric ulcer, intestinal obstruction, acute pancreatitis, and gall bladder disease have been reported. At least one case of cholecystitis has also been reported, in addition to case of peritonitis and a case of hemorrhoids and rectal prolapse.

The most common side effect associated with varenicline in clinical trials was nausea. Nausea was typically transient and described as mild or moderate in intensity; however, some patients experienced persistent nausea throughout treatment.


A 63-year-old male with stable bipolar disorder experienced a manic episode coincident with varenicline (the active ingredient contained in Chantix) therapy. The patient was admitted to an inpatient psychiatric unit and met criteria for a manic episode. He began exhibiting manic symptoms one week after initiating therapy with varenicline 1 mg twice daily for smoking cessation. Varenicline was stopped upon admission. Within one week of admission, he was euthymic, without manic or psychotic symptoms.

A 42-year-old female with a 17-year history of schizophrenia experienced exacerbation of schizophrenia coincident with varenicline therapy. She had been prescribed varenicline 2 mg for 5-days to help her stop smoking. The patient's mother reported a 5-day psychotic episode that began with increased activity. After she was advised to discontinue varenicline, she had no further exacerbation.

Psychiatric side effects have included insomnia (19%), abnormal dreams (9% to 13%), sleep disorder (2%), and nightmare (2%). Anxiety, depression, emotional disorder, irritability, restlessness, aggression, agitation, disorientation, dissociation, decreased libido, mood swings, abnormal thinking, bradyphrenia, euphoric mood, hallucination, psychotic disorder, suicidal ideation, and erratic behavior have also been reported. Depressed mood, agitation, changes in behavior, and suicide have been reported during postmarketing experience. At least one case of varenicline-induced manic episode has also been reported, in addition to a case of exacerbation of schizophrenia.

Nervous system

Nervous system side effects have frequently included headaches (10.3% to 19%), dysgeusia (8%), fatigue, malaise, asthenia, somnolence, and lethargy. Attention disturbances, dizziness, sensory disturbance, amnesia, migraine, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor, balance disorder, cerebrovascular accident, convulsion, dysarthria, facial palsy, mental impairment, multiple sclerosis, nystagmus, impairment of psychomotor skills, transient ischemic attack, visual field defect, and drowsiness have been reported.

The New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) identified a series of 13 reports of memory impairment in patients taking varenicline. This case series adds to cases of memory impairment reported by the Institute for Safe Medication Practices (ISMP) from FDA datasets who postulated that vasoconstriction or vasodilation could be the underlying mechanism.


Respiratory side effects have frequently included influenza (3.2% to 5.8%), rhinorrhea, dyspnea, and upper respiratory tract disorder. Epistaxis, respiratory disorders, asthma, pleurisy, and pulmonary embolism have also been reported.


Dermatologic side effects have frequently included rash and pruritus. Hyperhidrosis, acne, dermatitis, dry skin, eczema, erythema, psoriasis, urticaria, and photosensitivity reaction have also been reported.


Metabolic side effects have frequently included increased or decreased appetite and anorexia. Hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, and increased weight have also been reported.


Hematologic side effects have included anemia, lymphadenopathy, leukocytosis, thrombocytopenia, and splenomegaly.


Cardiovascular side effects have included angina pectoris, arrhythmia, bradycardia, ventricular extrasystoles, myocardial infarction, palpitations, tachycardia, atrial fibrillation, cardiac flutter, coronary artery disease, cor pulmonale, abnormal electrocardiogram, acute coronary syndrome, hypertension, hypotension, peripheral ischemia, and thrombosis.


Endocrine side effects have included thyroid gland disorders and diabetes mellitus. At least one case of pituitary hemorrhage has also been reported.


Ocular side effects have included conjunctivitis, dry eye, eye irritation, blurred vision, visual disturbance, eye pain, acquired night blindness, transient blindness, cataract subcapsular, ocular vascular disorder, photophobia, and vitreous floaters.


Hypersensitivity side effects including seasonal allergy (2.6% to 5.9%) have been reported.


Genitourinary side effects have included abnormal urine analysis, polyuria, nocturia, urine abnormality, urinary retention, menstrual disorder, erectile dysfunction, and sexual dysfunction. At least one case of ovarian hematoma has also been reported.


Musculoskeletal side effects have included arthralgia, back pain, muscle cramp, musculoskeletal pain, myalgia, arthritis, osteoporosis, and myositis.


Renal side effects have included nephrolithiasis, urethral syndrome, and acute renal failure. At least one case of elevated blood creatinine has also been reported.


Immunologic side effects commonly reported have included nasopharyngitis (35.9% to 51%), bronchitis, sinusitis, fungal infection, and viral infection.


Hepatic side effects including abnormal liver function tests have been reported.


Other side effects have included tinnitus, vertigo, deafness, Meniere's disease, chest pain, influenza-like symptoms, edema, thirst, chest discomfort, chills, pyrexia, increased muscle enzyme, and hot flash. At least one case of feeling abnormal has been reported, in addition to a case of elevated aspartate aminotransferase, two cases of elevated alanine aminotransferase, and one case of elevated blood bilirubin.


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