Posts Tagged ‘Chantix’

PEOPLE’S PHARMACY:Can drugs cause violent behavior?

Thursday, July 21st, 2011

Tuscaloosa News – July 21, 2011

PEOPLE’S PHARMACY

Americans revere personal responsibility. It resonates with our respect for accountability and frontier justice. That may explain why we have a hard time believing that medications could alter people’s personalities or lead them to behave badly.

Violence as a drug side effect seems preposterous to patients, pharmacists, physicians and even juries. Trying to use the “Prozac defense” to justify killing or hurting someone is often met with scorn.

Although drug-induced hostility or aggression has not been well-studied, a surprising number of medications come with precautions about violent acts.

Antidepressant prescribing information, for example, warns physicians that, “All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior.” Drugs such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil) and sertraline (Zoloft) carry warnings about aggressiveness, agitation, hostility, impulsivity and irritability.

The stop-smoking medication varenicline (Chantix) also comes with warnings about agitation, hostility, depressed mood and changes in behavior. The trouble with such warnings is that people don’t imagine that these bad things could happen to them. But many readers have shared scary stories about Chantix and violence. Here is one:

“I started taking Chantix early in January 2011 because I promised my son I’d quit. After about two weeks on the drug, my husband and I got into a disagreement, and I ended up giving him a black eye and busting out his tooth. Rage and panic attacks were occurring every day, so I quit taking Chantix.

“I figured it was just the stress of having to live with my in-laws, so I stayed off it until I left my husband and got my own place with my son. I’ve now been taking Chantix for about two weeks, and I’m having emotional outbursts and extreme rage again. I have no stress in my life right now, so it can’t be anything else but the drug.

“I’ve researched this, and apparently Chantix is at the top of a list of drugs that cause violent behavior. Chantix worked very well for a friend of mine to help her stop smoking, but now I wonder if it contributed to her breakup with her fiance.”

Other readers have shared stories of people who had no history of aggressiveness, violence or mental-health problems going berserk while taking Chantix. One man beat his wife and called police but had no recollection of the incident.

A recent article in the European Journal of Clinical Pharmacology (online, June 7, 2011) “confirms the risk of violence associated with benzodiazepines and related drugs (zopiclone and zolpidem). … Physical aggressiveness, rapes, impulsive decision making and violence have been reported, as have autoaggressiveness and suicide.”

Benzodiazepines are anti-anxiety agents such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium) and lorazepam (Ativan). Eszopiclone and zolpidem are popular prescription sleep aids. Americans need to know how prescribed drugs might affect their behavior. Only then can they take responsibility for their actions.

http://www.tuscaloosanews.com/article/20110721/NEWS/110719697/1005/sitemaps04?p=2&tc=pg

(Note from CCHR:  Our psychiatric drug database, comprised of international drug regulatory agency warnings and clinical studies,  contains 19 warnings of psychiatric drugs causing violence, aggression and hostility -  type in aggression in the red search box – or suicide which has 66 warnings)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php )

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New Study Links ADHD Drugs, Antidepressants, Hypnotics & Anti-Smoking Drug to 1,527 Acts of Violence

Thursday, December 16th, 2010

Pharmalot, December 16, 2010

by Ed Silverman

For years, there were contentious debates about links between certain prescription meds, notably antidepressants, and suicidal behavior. Now, the focus is turning to violent behavior directed toward others. And a new study is linking 31 widely prescribed drugs – most notably, the Chantix anti-smoking pill – with 1,527 serious acts of violence, such as physical abuse, physical assault and homicide.

The study, which was published in PLoS One, identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds, including 1,937 cases meeting the violence criteria determined by the researchers. There were 387 reports of homicide, 404 physical assaults, 27 cases indicating physical abuse, 896 homicidal ideation reports and 223 cases described as violence-related symptoms.

Besides Pfizer’s Chantix, 11 antidepressants, three ADHD meds and five hypnotics or sedatives were linked to 79 percent of the violence cases. Looked at another way, no cases of violence were reported for 324 of the 484 drugs evaluated. And so an association with violence appeared “highly unlikely” for nearly 85 percent of all evaluated drugs in widespread clinical use.

This is not, by the way, the first time that Chantix has been linked to violent behavior. The same authors published a study last summer in The Annals of Pharmacotherapy that found Chantix is not only associated with violent and aggressive thoughts and acts, but they also identified some of the common characteristics among people using the pill and their subsequent behavior (see this).

“Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. (Chantix), which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs,” the researchers write. Interestingly, this finding appears just after the infamous Zoloft defense case drew to a close. That involved a 12-year-old boy who killed his grandparents and his lawyers blamed the antidepressant (read here).

The authors do, however, cite some limitations. The submission of an individual adverse event report does not itself establish causality,” the note, “only that a reporting individual suspected a relationship existed.” And they add that the quality and detail in each report varies. On the other hand, they also say that, “given that violent thoughts or actions are not typically attributed to drug therapy or recorded in medical records, the reporting rate for violence cases could be very low. The selected violence cases do not provide a reliable estimate of how often they might occur.”

In the end, they recommend prospective studies to “establish the incidence, confirm differences among drugs and identify additional common features.”

http://www.pharmalot.com/2010/12/chantix-prescription-drugs-and-violent-acts/

Note from CCHR:  As far back as 1991, the FDA held hearings into antidepressants causing suicidal ideation and violence, largely prompted by CCHR’s demands for an investigation. CCHR testified along with dozens of victims and medical experts.   The FDA panel, largely Pharma funded, refused to issue warnings despite the evidence presented. It would take the FDA another 13 years to finally admit antidepressants cause suicidal ideation and issue black  box warnings on the drugs.  The FDA has still never fully investigated the overwhelming evidence linking antidepressants and other psychiatric drugs to acts of violence and homicide.

Watch this video, produced by CCHR, of the 1991 FDA hearings into antidepressants causing suicide and violence http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/6/FxJomeak4V4

Also Watch This Fox National News Special Report’s from Douglas Kennedy Deadly Drugs - http://www.youtube.com/watch?v=9S-7aNPf33A

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US Soldiers’ Suicides Caused by Prescription Drugs?

Monday, November 1st, 2010

The Epoch Times, November 1, 2010

by Martha Rosenberg

The suicide rate among U.S. troops is astonishing.

In 2009 there were 239 suicides within the Army, including the Reserves, 160 active duty suicides, 146 active duty deaths from drug overdoses and high-risk behavior, and 1,713 suicide attempts, says the Army’s suicide report released in July.

More troops are dying from their own hands than in combat, says the Army report, titled “Health Promotion, Risk Reduction, and Suicide Prevention.” Thirty-six percent of the suicides were among troops who were never deployed.

Also astonishing is the psychoactive prescription drug rate among active duty-aged troops, aged 18 to 34, which is up 85 percent since 2003, according to the military health plan, Tricare. Including family prescriptions, since 2001, 73,103 prescriptions for Zoloft have been dispensed, 38,199 for Prozac, 17,830 for Paxil, and 12,047 for Cymbalta. All of the drugs carry a suicide-warning label.

In addition to the spike in SSRI antidepressant prescriptions, prescriptions for the anticonvulsants Topamax and Neurontin rose 56 percent in the same group since 2005, says Navy Times. The FDA warned last year that taking these drugs doubles suicidal thinking.

In fact, 4,994 troops at Fort Bragg, N.C., are on antidepressants right now, says the Fayetteville Observer. Six hundred and sixty-four are on an antipsychotic and “many soldiers take more than one type of medication.”

Troops may also be taking Chantix, an antismoking drug so linked to violence and self-harm that Secretary of Veterans Affairs James Peake was forced to defend its use before the House Committee on Veterans Affairs in 2008 even in drug trials. Related Articles

“If you know the drug induces suicidal thoughts,” an unappeased committee chair Bob Filner, D-Calif., asked Rep. Filner, “Why don’t you just stop [prescribing it]?”

The FDA says that even widely prescribed asthma drugs like Singulair and Advair are linked to suicide and have been cited in young people’s deaths.

Who knows what happens when the drugs are mixed with mood stabilizers, insomnia meds, pain pills, anti-anxiety drugs, and antipsychotic pills? These drug combinations have never been tested for safety.

Links between suicide and even murder-suicide and selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) antidepressants have been long recognized.

Traci Johnson, a healthy 19-year-old with no mental problems, hung herself during Lilly trials of Cymbalta in the drugmaker’s own clinic in 2004. Columbine shooter Eric Harris had reportedly just switched from Zoloft to Luvox.

Red Lake shooter Jeff Weise who killed 10 on a Minnesota Native American reservation in 2005 had just upped his Prozac dose. And the Virginia Tech shooter, Cho Seung-Hui, was also on psychoactive medications, say news reports.

Even though Americans have doubled their antidepressants since 1999 so that 10 percent of the population or 27 million now take them, suicides have climbed by 5 percent since 1999 and 16 percent in middle-aged adults, says an article in the American Journal of Preventive Medicine in 2008.

In fact, the high percentage of civilian suicides on psychoactive drugs is probably the clearest indication that military life is not the only cause of the shocking troop suicides.

In September alone, there were 18 civilian suicides, 11 murders, 2 murder-suicides, and other violence linked to people who were using or had used antidepressants, according to published reports. (Ssristories.com/index.php?sort=what&p=recent)

A 54-year-old patient with a breathing tube and an oxygen tank and no previous criminal record held up a bank in Mobile, Ala. She had gone off her antidepressants.

An enraged man in Australia, also off his antidepressants, chased his mailman and threatened to cut his throat for bringing him junk mail.

A 58-year-old Amarillo, Texas, man with no criminal history tried to abduct three people, killing an Oklahoma grandmother in the process. He had “an antidepressant in his blood,” said police.

Also in the 30-day period, a 60-year-old grandmother in Seattle killed three family members and herself; a disc jockey in Bristol, U.K., set himself on fire; and a man in Exeter, U.K., was found to have stabbed himself in the heart. All were on antidepressants.

Finally, in the month of September, legal proceedings began against two mothers and a father charged with killing their own children.

Over 4,000 published reports of violent and bizarre behavior of people affected by antidepressants on the Web archive ssristories.com reveal the same out-of-character violence and self-harm in civilians that is currently seen in the military.

Twenty people set themselves on fire. Ten bit their victims (including a biter who was sleepwalking and a woman, on Prozac, who bit her 87-year-old mother into a critical condition.) Three men in the 70s and 80s attacked their wives with hammers.

Many stabbed their victims obsessively—one even stabbed furniture after killing his wife—and 14 parents drowned their children, a crime seldom heard of before the 2001 Andrea Yates case. Yates, who drowned her five children, was on the antidepressant Effexor, which manufacturer Wyeth (now Pfizer) “issued no public warning” about [the possibility of violent behavior], says the Associated Press.

Then there was the North Carolina pilot on Zoloft who sang “I’m going down for the last time” into the cockpit voice recorder before he crashed his plane in June. And the mayor of Coppell, Texas, Jayne Peters, who killed herself and her daughter in July over the grief of losing her husband. Police found antidepressants at the home.

Such murder-suicides committed by women used to be rare, says Betty Henderson the ssristories.com moderator and researcher. “Before the SSRI antidepressants, women committed 5 percent of the murder-suicides, and now they account for almost 15 percent of this type of violence,” she said in an interview.

Antidepressants are also causing women to become sexual predators, says Henderson. “There have been more than a dozen recent cases of women school teachers molesting their young students under the influence or withdrawal of antidepressants. Who heard of this type of sexual aberration before the antidepressant craze?”

Why don’t doctors and media outlets publicize the names of these volatile drugs?

“It’s a good question,” said Dr. Gary Kohls, a Minnesota family practitioner, in an op-ed written after Iraq veteran Matthew Magdzas killed his pregnant wife, their 13-month-old daughter, their dogs, and himself in Wisconsin in August.

“Nobody in the media has, to my knowledge, had the courage to report what the drugs were, nor have they interviewed the physician or his clinic to find out the rationale for prescribing drugs that have common violence-inducing effects (with black box warnings stating that in the prescribing information),” he writes. “Therefore nothing has been learned from this important teachable moment, probably because revealing the common reality of prescription drug-induced violence would be economically harmful for the sacred cows of Big Pharma and Big Medicine.”

Sen. Jim Webb, D-Va., called the fact that one of every six troops are now on psychoactive drugs “pretty astounding and also very troubling,” in Senate hearings this year.

Retired Col. Bart Billings, a former Army psychologist who has also testified before Congress, says, “I feel flat-out that psychiatrists are directly responsible for deaths in our military, for some of these suicides,” in a March Marine Times article. “I think it’s criminal, what they are doing.”

Even Katie Bagosy, the wife of Marine Sgt. Tom Bagosy, who took his own life in May, indicts the Neurontin medication he was prescribed for his downfall.

“He told me, ‘It all started to get worse when I got on this medication.’ Looking back, that was the beginning of the end,” she says in an article called “A Prescription for Tragedy” in the current National Journal.

http://www.theepochtimes.com/n2/content/view/45181/

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Chantix & Violence: What Patients Have In Common

Thursday, July 22nd, 2010

Pharmalot
By Ed Silverman
July 22, 2010

For the past three years, the Chantix smoking cessation pill has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med (see this). The FDA subsequently imposed a risk management program and Pfizer added warnings.

Now, a new study in The Annals of Pharmacotherapy finds Chantix is not only associated with violent and agressive thoughts and acts, but has also identified some of the common characteristics among people using the pill and their subsequent behavior. The drug “does have warnings about psychiatric side effects, but it skims over aggression/violence towards others to focus mainly on suicidal behaviors,” says Thomas Moore, one of the co-authors and a senior scientist at the Institute for Safe Medication Practices, a non-profit that has issued reports previously about Chantix side effects.

“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 researchers obtained 78 adverse event reports from the FDA MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; four more cases came from clinical trials, and three others came from published literature. Ultimately, they used 26 case reports for study and these described 10 events with assault, nine cases of homicidal ideation and seven instances of other thoughts or acts of aggression/violence. They noted that the patient population was predominantly middle-aged women, but “an unlikely age group and sex for assault and acts of violence toward others.”

“In all 26 cases,” they write, “the acts or thoughts of violence appeared to be inexplicable and unprovoked. A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car, with a young granddaughter also present. A 42-year-old man punched a stranger at a bowling alley. The stranger and two friends responded and knocked out the subject’s front teeth. A 24-year-old female started beating her boyfriend in bed because he “looked so peaceful” and she later attempted suicide. A 29-year-old female struck an acquaintance twice in the face, and then started smashing doors in her own home and beating on her truck.”

Read entire article:  http://www.pharmalot.com/2010/07/chantix-and-violence-what-patients-have-in-common/

*The package insert for Chantix shows that it contains a type of chemical compound that is better known as benzodiazepine—benzodiazepines are otherwise known as anti-anxiety drugs.

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Pfizer Makes Bank from DrugsThat Can Kill You—To say Pfizers been accused of wrongdoing is like saying BP had an oil spill

Monday, July 12th, 2010

AlterNet
By Martha Rosenberg
July 10, 2010

The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

But the “world’s largest research-based pharmaceutical company” which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

To say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8 ) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

Nor does Pfizer back down when faced with legal troubles.

Even as it was under the probation of a 5-year Corporate Integrity Agreement (CIA) with Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002, it off-label marketed its seizure drug Neurontin and entered into another CIA in 2004.

Read entire article:  http://www.alternet.org/story/147467/

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