Safe Medication Practices and Wake Forest University study shows that the anti-smoking drug Chantix used to help to quit smoking is associated with hundreds of reported problems since the drug's 2006 FDA approval that included blurred vision, dizziness, confusion and loss of consciousness.
"A drug-watchdog group has flagged serious physical side effects possibly linked to Pfizer's popular smoking-cessation medicine Chantix, casting a pall over a drug already dogged by psychiatric issues and shining the spotlight anew on the adequacy of the Food and Drug Administration's drug-safety monitoring."
On CNBC, which I was listening to at the time, they report it also as Breaking news from the WSJ. What was reported on CNBC was New side effects in people using Pfizer's popular smoking-cessation medicine Chantix. One reported side effect is: HEART TROUBLE or CARDIAC DISORDERS. HULIQ has the executive summary of Chantix warning study from Safe Medication Practices Institute.
If you read the Outline below, you will see that in Fact these New Adverse Reactions are Already Known, Just Not reported to the Public. As most New Warnings , they are reported only when someone using the Drug has a severe reaction that is made public, and the reaction is related to the Drug. There is NO date on this report. However they do make this statement at the beginning:
"During the premarketing development of CHANTIX, over 4500 individuals were exposed to CHANTIX, with over 450 treated for at least 24 weeks and approximately 100 for a year. Most study participants were treated for 12 weeks or less."
So they did in fact know of these Newly reported Side Affects from using CHANTIX. Their Premarketing Development states this. They just didn't tell the public.
CHANTIX (varenicline) Tablets Adverse Reactions
The following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.
BLOOD AND LYMPHATIC SYSTEM DISORDERS. Infrequent: Anemia, Lymphadenopathy. Rare: Leukocytosis, Thrombocytopenia, Splenomegaly.
CARDIAC DISORDERS. Infrequent: Angina pectoris, Arrhythmia, Bradycardia, Ventricular extrasystoles, Myocardial infarction, Palpitations, Tachycardia. Rare: Atrial fibrillation, Cardiac flutter, Coronary artery disease, Cor pulmonale, Acute coronary syndrome.
EAR AND LABYRINTH DISORDERS. Infrequent: Tinnitus, Vertigo. Rare: Deafness, Meniere's disease.
ENDOCRINE DISORDERS. Infrequent: Thyroid gland disorders.
EYE DISORDERS. Infrequent: Conjunctivitis, Dry eye, Eye irritation, Vision blurred, Visual disturbance, Eye pain. Rare: Acquired night blindness, Blindness transient, Cataract subcapsular, Ocular vascular disorder, Photophobia, Vitreous floaters.
GASTROINTESTINAL DISORDERS. Frequent: Diarrhea, Gingivitis. Infrequent: Dysphagia, Enterocolitis, Eructation, Gastritis, Gastrointestinal hemorrhage, Mouth ulceration, Esophagitis. Rare: Gastric ulcer, Intestinal obstruction, Pancreatitis acute.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS.Frequent: Chest pain, Influenza like illness, Edema,
Thirst. Infrequent: Chest discomfort, Chills, Pyrexia.
HEPATOBILIARY DISORDERS. Infrequent: Gall bladder disorder.
IMMUNE SYSTEM DISORDERS. Infrequent: Hypersensitivity. Rare: Drug hypersensitivity.
INVESTIGATIONS. Frequent: Liver function test abnormal, Weight increased. Infrequent: Electrocardiogram abnormal, Muscle enzyme increased, Urine analysis abnormal.
METABOLISM AND NUTRITION DISORDERS. Infrequent: Diabetes mellitus, Hyperlipidemia, Hypokalemia. Rare: Hyperkalemia, Hypoglycemia.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS. Frequent: Arthralgia, Back pain, Muscle cramp, Musculoskeletal pain, Myalgia. Infrequent: Arthritis, Osteoporosis. Rare: Myositis.
NERVOUS SYSTEM DISORDERS. Frequent: Disturbance in attention, Dizziness, Sensory disturbance. Infrequent: Amnesia, Migraine, Parosmia, Psychomotor hyperactivity, Restless legs syndrome, Syncope, Tremor. Rare: Balance disorder, Cerebrovascular accident, Convulsion, Dysarthria, Facial palsy, Mental impairment, Multiple sclerosis, Nystagmus, Psychomotor skills impaired, Transient ischemic attack, Visual field defect.
PSYCHIATRIC DISORDERS. 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.
RENAL AND URINARY DISORDERS. Frequent: Polyuria. Infrequent: Nephrolithiasis, Nocturia, Urine abnormality, Urethral syndrome. Rare: Renal failure acute, Urinary retention.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS. Frequent: Menstrual disorder. Infrequent: Erectile dysfunction. Rare: Sexual dysfunction.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS. Frequent: Epistaxis, Respiratory disorders. Infrequent: Asthma. Rare: Pleurisy, Pulmonary embolism.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS. Frequent: Hyperhidrosis. Infrequent: Acne, Dermatitis, Dry skin, Eczema, Erythema, Psoriasis, Urticaria. Rare: Photosensitivity reaction.
VASCULAR DISORDERS. Frequent: Hot flush, Hypertension. Infrequent: Hypotension, Peripheral ischemia, Thrombosis.
Post-Marketing Experience of Chantix:
The following adverse events have been reported during post-approval use of Chantix. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been reports of depressed mood, agitation, changes in behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Chantix. Smoking cessation with or without treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. Not all patients had known pre-existing psychiatric illness and not all had discontinued smoking.
SOURCE: Pfizer