A report in the Annals of Pharmacotherapy, by Thomas J Moore, Joseph Glenmullen, MD, and Curt D Furberg MD, documents startling evidence showing that Chantix triggers sudden, unprovoked homicidal behavior in people who were not previously violent.
"We believe this may be the first scientific report to examine the characteristics of aggression/violence as a psychiatric side effect for any prescription drug. What do these cases look like? A question answered for possibly the first time. We found the details striking and chilling. This is the first time we know of that aggression/violence has been clearly documented as a side effect in a peer reviewed scientific journal. This raises the question of whether (Chantix) is suitable for use in the military, by police and others who are already in stress situations. One key characteristic of these events is uncontrollable rage. Not a good side effect for people paid to carry guns.”
The evidence, culled from 78 adverse psychiatric events reported to the FDA MedWatch database; 4 reported in clinical trials, and 3 were reported in the published literature, is compelling. Using psychiatric diagnostic criteria and an adverse event causality assessment tool the authors identified 26 case reports for study.
The selected cases described 10 events with assault, 9 cases of homicidal ideation, and 7 cases of other thoughts or acts of aggression/violence. The most frequent common characteristics were (1) inexplicable and unprovoked event, (2) the victim was anyone nearby, (3) no indication of a prior history of similar behavior in the patient, and (4) early onset of psychiatric adverse effects, often before stopping smoking.
The authors note, "Where dechallenge/rechallenge information was available, psychiatric adverse effects resolved in 13/14 (93%) cases after discontinuation." Dechallenge/ rechallenge tests withdraw the drug to see if the adverse effects recede, then reintroduce the drug to see if they return. Dechallenge/ rechallenge tests provide irrefutable evidence for causal drug effects--they provide definitive evidence which placebo-controlled trials often do not. Few subjects are needed to make a positive identification, but manufacturers prefer ambiguity rather than definitive evidence about their drug's risks.
The truth about the most serious FDA-approved drug hazards were concealed from the public for years--even when FDA officials knew (or should have known) about the dangers--as these were documented in the agency's files. Only when aggrieved consumers sued manufacturers did the truth about these drugs' potentially lethal effects come to light during the discovery process. Drug manufacturers much prefer to settle even paying hundreds of millions--even billions of dollars--years after they have reaped multi-billion dollars in profits.
Since its approval, in May, 2006, an increasing number of adverse drug event reports about serious psychiatric adverse effects led to an escalating series of FDA regulatory actions that included an “Early Communication” of a possible risk, two public health advisories, a requirement for a Risk Evaluation and Management Strategy, a mandatory Medication Guide to be given to every patient, and a black boxed warning on the product package insert. However, the FDA has not seen fit to warn the public about the evidence that the drug triggers unprovoked murderous rage--surely, a danger to society.
The authors reported the following conflicts: a portion of the research was performed under consulting contracts with the US Army Trial Defense Service in connection with expert testimony in a criminal case [ Moore and Glenmullen]. The Army had no involvement in the conduct, design, or conclusions reached, they write. And Glenmullen has been retained as a potential consultant in legal cases involving the drug.
Moore TJ, Glenmullen J, Furberg CD. Thoughts and Acts of Aggression/Violence Toward Others Reported in Association with Varenicline(September) (FREE). Ann Pharmacother:aph.1P172.
BACKGROUND: Thoughts and acts of aggression/violence toward others have been reported in postmarketing surveillance of varenicline, an aid to smoking cessation.
OBJECTIVE: To identify the common characteristics of these thoughts and acts of aggression/violence toward others and assess the likely relationship to varenicline treatment.
METHODS: We obtained 78 adverse event reports from the Food and Drug Administration MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; 4 additional cases were reported in clinical trials, and 3 others came from the published literature. We used psychiatric diagnostic criteria and an adverse event causality assessment tool to identify 26 case reports for study.
RESULTS: The selected cases described 10 events with assault, 9 cases of homicidal ideation, and 7 cases of other thoughts or acts of aggression/violence. The most frequent common characteristics were (1) inexplicable and unprovoked event, (2) the victim was anyone nearby, (3) no indication of a prior history of similar behavior in the patient, and (4) early onset of psychiatric adverse effects, often before stopping smoking. Where dechallenge/rechallenge information was available, psychiatric adverse effects resolved in 13/14 (93%) cases after discontinuation.
CONCLUSIONS: The clear temporal relationship, lack of prior history of this behavior, and unusual nature of these events strengthens the accumulating scientific evidence that varenicline is associated with thoughts and acts of aggression/violence. We recommend that physicians and pharmacists ensure that all patients are informed of possible psychiatric symptoms of varenicline, including violent and aggressive thoughts. All patients should be advised to contact a health-care provider immediately if these symptoms occur and varenicline should be discontinued without delay.
"We believe this may be the first scientific report to examine the characteristics of aggression/violence as a psychiatric side effect for any prescription drug. What do these cases look like? A question answered for possibly the first time. We found the details striking and chilling. This is the first time we know of that aggression/violence has been clearly documented as a side effect in a peer reviewed scientific journal. This raises the question of whether (Chantix) is suitable for use in the military, by police and others who are already in stress situations. One key characteristic of these events is uncontrollable rage. Not a good side effect for people paid to carry guns.”
The evidence, culled from 78 adverse psychiatric events reported to the FDA MedWatch database; 4 reported in clinical trials, and 3 were reported in the published literature, is compelling. Using psychiatric diagnostic criteria and an adverse event causality assessment tool the authors identified 26 case reports for study.
The selected cases described 10 events with assault, 9 cases of homicidal ideation, and 7 cases of other thoughts or acts of aggression/violence. The most frequent common characteristics were (1) inexplicable and unprovoked event, (2) the victim was anyone nearby, (3) no indication of a prior history of similar behavior in the patient, and (4) early onset of psychiatric adverse effects, often before stopping smoking.
The authors note, "Where dechallenge/rechallenge information was available, psychiatric adverse effects resolved in 13/14 (93%) cases after discontinuation." Dechallenge/ rechallenge tests withdraw the drug to see if the adverse effects recede, then reintroduce the drug to see if they return. Dechallenge/ rechallenge tests provide irrefutable evidence for causal drug effects--they provide definitive evidence which placebo-controlled trials often do not. Few subjects are needed to make a positive identification, but manufacturers prefer ambiguity rather than definitive evidence about their drug's risks.
The truth about the most serious FDA-approved drug hazards were concealed from the public for years--even when FDA officials knew (or should have known) about the dangers--as these were documented in the agency's files. Only when aggrieved consumers sued manufacturers did the truth about these drugs' potentially lethal effects come to light during the discovery process. Drug manufacturers much prefer to settle even paying hundreds of millions--even billions of dollars--years after they have reaped multi-billion dollars in profits.
Since its approval, in May, 2006, an increasing number of adverse drug event reports about serious psychiatric adverse effects led to an escalating series of FDA regulatory actions that included an “Early Communication” of a possible risk, two public health advisories, a requirement for a Risk Evaluation and Management Strategy, a mandatory Medication Guide to be given to every patient, and a black boxed warning on the product package insert. However, the FDA has not seen fit to warn the public about the evidence that the drug triggers unprovoked murderous rage--surely, a danger to society.
The authors reported the following conflicts: a portion of the research was performed under consulting contracts with the US Army Trial Defense Service in connection with expert testimony in a criminal case [ Moore and Glenmullen]. The Army had no involvement in the conduct, design, or conclusions reached, they write. And Glenmullen has been retained as a potential consultant in legal cases involving the drug.
Moore TJ, Glenmullen J, Furberg CD. Thoughts and Acts of Aggression/Violence Toward Others Reported in Association with Varenicline(September) (FREE). Ann Pharmacother:aph.1P172.
BACKGROUND: Thoughts and acts of aggression/violence toward others have been reported in postmarketing surveillance of varenicline, an aid to smoking cessation.
OBJECTIVE: To identify the common characteristics of these thoughts and acts of aggression/violence toward others and assess the likely relationship to varenicline treatment.
METHODS: We obtained 78 adverse event reports from the Food and Drug Administration MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; 4 additional cases were reported in clinical trials, and 3 others came from the published literature. We used psychiatric diagnostic criteria and an adverse event causality assessment tool to identify 26 case reports for study.
RESULTS: The selected cases described 10 events with assault, 9 cases of homicidal ideation, and 7 cases of other thoughts or acts of aggression/violence. The most frequent common characteristics were (1) inexplicable and unprovoked event, (2) the victim was anyone nearby, (3) no indication of a prior history of similar behavior in the patient, and (4) early onset of psychiatric adverse effects, often before stopping smoking. Where dechallenge/rechallenge information was available, psychiatric adverse effects resolved in 13/14 (93%) cases after discontinuation.
CONCLUSIONS: The clear temporal relationship, lack of prior history of this behavior, and unusual nature of these events strengthens the accumulating scientific evidence that varenicline is associated with thoughts and acts of aggression/violence. We recommend that physicians and pharmacists ensure that all patients are informed of possible psychiatric symptoms of varenicline, including violent and aggressive thoughts. All patients should be advised to contact a health-care provider immediately if these symptoms occur and varenicline should be discontinued without delay.
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