Sept, 9 2000
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Bupropion FDA MEDWATCH Report - Shattered Lives, Startling Statistics
Zyban/Wellbutrin FDA AERS MEDWATCH report covering a time span of less than 18 months (1997-1999), revealed 1,153 individual reports, citing a high number of adverse events. The vast majority of reports cited multiple ADEs within each. Contained within this particular report were both type A and type B ADEs citing bupropion -Wellbutrin IR, Wellbutrin SR and Zyban - as the Primary Suspect Drug (PSD). Within each classification citing bupropion as the PSD, varying ADE frequencies and constellations were noted. Though the bulk of the events were classified as type A, many were nonetheless serious. The DPMs for Wellbutrin IR, SR, and Zyban have been changed a number of times over the years to accommodate the growing number of ADEs associated with bupropion usage. The voluminous amount of ADEs noted within each, a number serious, life- threatening and disabling, afford wide latitude in regards classification of events, as per FDA A or B classification.
The type A events, though not unexpected, were often nonetheless serious and only further serve to raise serious questions in regards the safety of the drug. Despite the fact that the FDA prefaces its report with a disclaimer which reads: "The information contained in these reports has not been scientifically or otherwise verified as to a cause and effect relationship...", the vast majority of the ADEs listed have been and are currently included in the Drug Product Monographs. Given the established fact that frequency data is all but impossible to ascertain via FDA capabilities and that according to an 1990 Associated Press release, the FDA had only about 80 employees monitoring over 3,000 prescription drugs, the events noted can conceivably be translated into nothing more than sterile statistics, in effect the fact that human beings suffered from their toll being of no import at all. With the exception of deaths noted, indiscernible is the current state of health concerning those who suffered the adverse events listed within the report.
Bupropion being widely known for it's propensity to "lower the seizure threshold", as would be expected a number of Convulsive and Grand Mal events were noted within the MEDWATCH report. Though obviously not indicative of general population exposure/risk percentages, (which have yet to be conclusively ascertained by any methodology), it is nonetheless noteworthy that extrapolation of the 1997/1999 data citing Grand Mal Convulsion events, Petit Mal incidence, and non-specific Convulsion events reveals bupropion as the PSD, (exclusive of those attributed to noted overdose situations, classified as either intentional or unspecified, and those attributed to drug maladministration) within 17.43% (201) of the 1,153 reports. Given the estimated ADE reporting incidence rates as being between 1% and 10%, it is conceivable that anywhere from over 2,000 to over 20,000 events actually occurred within the report's short time frame. Zyban/Wellbutrin SR appeared in 9.28% of the total reports, Wellbutrin IR in 8.15%. Among the Deaths associated with bupropion, (cited below), one was attributed to a Zyban related Grand Mal event. A high number of reports cited the vast majority of these events as requiring hospitalisation (initial or long term), intervention measures to prevent permanent impairment/damage, and/or were classified as life threatening and/or disabling. The actual overall frequencies of events classified as such are indiscernible, as a number of the outcomes were not cited within the report.
Events appearing within individual reports in conjunction with Convulsive events included, but were by no means limited to, Abnormal Electroencephalogram with Fall, Loss of Consciousness and Muscle Spasm; Loss of Consciousness with Jaundice, Dermatitis and Confusion; Loss of Consciousness with Urinary Incontinence, Speech Disorder and Feeling Abnormal; Loss of Consciousness with Amnesia, Eye-rolling and Dizziness; Loss of Consciousness with Epitaxis, Haematemesis, and Anxiety; Loss of Consciousness with Headache and Mental Impairment; Depressed Level of Consciousness with Speech Disorder, Eyes Gazing Upward, Jerky Movements, Pharyngitis, Pyrexia, and Urinary Incontinence; Depressed Level of Consciousness with Chest Pain and Disorientation; Depressed Level of Consciousness with Dyskinesia and Eye-rolling; Amnesia with Choking and Confusion; Amnesia with Dehydration, Hypoesthesia, Blurred Vision and Weakness; Head Injury with Heametemesis, Photopsia, Pneumonia, Tremor and Blurred Vision; Haematemesis with Aggressiveness, Blurred Vision, Tremor and Anxiety; Fall with Head Injury, Tardive Dyskinesia and Dysarthria; Dyspnoea with Chest Pain, Tremor, Headache and Dizziness; Head Injury with Amenorrhoea and Amnesia; Psychotic Disorder with Agitation; Staring with Agitation, Markedly Reduced Food Intake, and Nausea; Bundle Branch Block with Electrocardiogram Qrs Complex Prolonged and Sinus Tachycardia; and Myocardial Infarction, just to name a few.
Taking incidences of non-specific Convulsions out of the equations, Zyban/Wellbutrin SR revealed a 2.86% Grand Mal incidence rate, Wellbutrin IR a 2.68% rate. Zyban's incidence rate for Grand Mal events made for nearly two thirds of the culminative Zyban/Wellbutrin SR rates. Where noted, approximately 70% of the Zyban Grand Mal incidents were accompanied by additional ADEs, including, but not limited to Status Epilepticus, Complex Partial Seizure, Cerebral Infarction, Brain Neoplasm, Arterial Rupture, Cellulitis, Upper Limb Oedema, Lower Limb Oedema, Face Oedema, Haemorrhage, Visual Field Defect, Neurological Disorder, Speech Disorder, Difficulty Walking, Tremor, Amnesia, Hallucination, Dissociation, Disorientation, Confusion, Head Injury, Fracture, Joint Dislocation, Laceration, Ecchymosis, Localized Exfoliation, Drug Eruption, and Urticaria.
Interestingly enough, the SR/Zyban formulation, claimed to be associated with the lower of the two formulations' seizure risk claims, was higher in these reports. This phenomenon could conceivably be due to under-reporting or lower usage rates concerning the IR formulation, though such data is all but impossible to ascertain.
Seizure/Convulsive events notwithstanding, a number of deaths were noted within the report citing bupropion as the PSD. Of the 57 deaths cited, 32 were deemed either unexplained or due to various events. The remainders were attributed to suicides or non-accidental overdoses (2 alcohol related), non-specific overdoses, or due to drug maladministration. Of the 32, causes were noted as resulting from Non-specific Cardiovascular Accident; Cerebral Vascular Accident; Cardiac Arrest accompanied with Pulmonary Embolism; Myocardial Infarctions; Myocardial Infarction accompanied with Haemorrhage, Respiratory Failure, Anaemia, and Cerebrovascular Incident; Atrial Fibrillation accompanied with Pulmonary Oedema; Ventricular Hypertrophy; Cerebral Aneurysm accompanied with Pneumonia; Cerebral Arteritis; Drowning; Asphyxiation accompanied with Convulsions; Grand Mal Seizure; Influenza-type Illness; Spontaneous Abortion; and Intra-uterine Death.
As to the significance of the Spontaneous Abortion and Intra-uterine Deaths cited, to date the manufacturer maintains, "There is no evidence of impaired fertility or harm to foetus due to bupropion. ("Pregnancy: Teratogenic Effects: Pregnancy Category B".) The manufacturer also states, "The effect on labor and delivery in humans is unknown." (Labor and Delivery".) According to a US patent submission for an alternative smoking cessation natural product, "bupropion has mutagenicity effects which can be associated with birth defects." The patent application cites the 1998 Physician's Desk Reference, Medical Economic Company Inc., as its source for this assertion.
In Canada, The Therapeutic Products Programme, which monitors and assesses suspected ADRs, revealed over 400 individual reports concerning exclusively Zyban related events since the drug's introduction in August of 1998, numerous events noted within many of the reports. It is beyond the scope of this report to go into detail concerning the reports and events, many serious, some deadly. However, suffice it to say, the events noted were of the same nature as those reported in the aforementioned FDA MEDWATCH report. Of special note is the fact that over 90 of the ADR symptoms cited were noted as NOT being labelled in the Canadian Zyban DPM, dated as of August 19, 1999.
In conclusion, the grave state of affairs surrounding the astronomical toll many pharmaceuticals have and continue to take in terms of human suffering, disability and death has become so unavoidably apparent, the United States Congress was forced in 1999 to address them once again, having already done so nearly thirty years earlier during FDA hearings held in the 1970's. At a Drug Information Association meeting held in Washington, D.C., Senator Kennedy (D-Massachusetts), concurred that one of the main criticisms to be levelled against the FDA MEDWATCH program was that it is a voluntary system, admitting that, "Busy physicians often fail to report adverse reactions that might be associated with medications." It was revealed that due to failure on the part of Congress to address the already known serious problems concerning ADRs following the 70's FDA hearings, they had yet to pass legislation necessary to follow up on the post-marketing surveillance needs formerly established in 1979. Kennedy maintained "the lack of consistent reporting remains a serious problem and action is urgently needed." Tragically, current efforts towards taking action have proven to be too little, too late for the untold number of individuals exposed to bupropion who have died, are suffering from long term illnesses and disabilities secondary to the drug, and for the families and loved ones of all who have had the largely preventable misfortune of incurring these damages facilitated by the lack of truthful dissemination of information surrounding Zyban/Wellbutrin.
In conclusion, given the vastly incomplete aforementioned facts and contentions, it is inescapable that truth is stranger than fiction - more horrific than could be penned by the darkest of minds and the keenest of imaginations. Indeed, the replacement theology of the day is shamefully alive and well: namely, the deification of the Almighty Dollar at the expense of the very sanctity of human life itself.
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