Top Ten Legal Drugs Linked to Violence

By Maia Szalavitz Friday, January 7, 2011, TIME Magazine

When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA's Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.

Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they're used to try to stop it.

Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons. Here are the top ten offenders:

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.

9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior.

8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence

7. Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.

6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.

5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.

4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain's dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.

3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs.

2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.

1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it's 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. 

Dangerous Drugs Big Pharma Shoves Down Our Throats

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. And the public suffers. 

By Martha Rosenberg, AlterNet
November 19, 2010

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. Long studies to truly assess a drug's risks just delay profits after all -- and if problems do emerge after medication hits the market, settlements are usually less than profits. Remember, Vioxx still made money.

The following drugs are so plagued with safety problems, it is a wonder they’re on the market at all. It's a testament to Big Pharma's greed and our poor regulatory processes that they are.

-- Lipitor and Crestor
Why is Lipitor the bestselling drug in the world? Because every adult with high LDL or fear of high LDL is on it. (And also 2.8 million children, says Consumer Reports.) No one is going to say statins don't prevent heart attack in high-risk patients (though diet and exercise have worked in high-risk groups too). But doctors will say statins are so over-prescribed that more patients get their side effects -- weakness, dizziness, pain and arthritis -- than heart attack prevention. Worse, they think it's old age!

"My older patients literally do without food so that they can buy these medicines that make them sicker, feel bad, and do nothing to improve life," says an ophthalmologist web poster from Tennessee. "There is no scientific basis for treating older folks with $300+/month meds that have serious side-effects and largely unknown multiple drug interactions." What kinds of side effects? All statins can cause muscle breakdown (called rhabdomyolysis) but combining them with antibiotics, protease inhibitors drugs and anti-fungals increases your risks. In fact, Crestor is so highly linked to rhabdomyolysis it is double dissed: Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before Congress.


-- Yaz and Yasmin

It sounded too good to be true and it was. Birth control pills that also cleared up acne, treated severe PMS (Premenstrual Dysphoric Disorder or PMDD) and avoided the water retention of traditional birth control pills.

But soon after Bayer launched Yaz in 2006 as going "beyond birth control," 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. Fifteen-year-old Katie Ketner had her gallbladder removed. Susan Gallenos had a stroke and part of her skull removed. College student Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli from taking Yaz, says her mother Joan Cummins.

While TV ads for Yaz in 2008 were so misleading that FDA ordered Bayer to run correction ads, Yaz sales are still brisk. In fact, financial analysts attribute the third quarter slump in the Yaz "franchise" of 28.1 percent to the appearance of a Yaz generic, not to the thousands of women who have been harmed.

Why is Yaz sometimes deadly? It includes a drug that was never before marketed in the U.S. -- drospirenone -- and apparently causes elevated potassium, heart problems, and a change in acid balance of the blood. Who knew? But not only is Bayer still marketing it, women do not receive "test subject" compensation for using it either.

-- Lyrica, Topomax and Lamictal

Why would Americans take an epilepsy seizure drug for pain? The same reason they'll take an antipsychotic for the blues and an antidepressant for knee pain: good consumer marketing. In August FDA ordered a warning for aseptic meningitis, or brain inflammation, on Lamictal -- but it is still the darling of military and civilian doctors for unapproved pain and migraine. Lamictal also has the distinction of looting $51 million from Medicaid last year despite a generic existing.

All seizure drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels. An April article in JAMA found seizure drugs linked to 26 suicides, 801 attempted suicides, and 41 violent deaths in just five years.

All three drugs can make you lose your memory and your hair, say posters on the drug rating site askapatient.com. Topamax is referred to as "Stupamax" in the military -- though evidently not enough to ask, "Why am I taking this drug again?"

-- Humira, Prolia and TNF Blockers

If you think pharma is producing a lot of expensive, dangerous injectables lately, you're right. Yesterday's blockbuster pills have been supplanted with vaccines and biologics that are more lucrative and safer...from generic competition, that is. The problem is, not only are biologics like Humira and Prolia creepy and dangerous -- they're made from genetically engineered hamster cells and suppress the actual immune system -- the diseases they treat are "sold" to healthy people.

Recently, thousands of college students in Chicago found inserts in their campus newspapers hawking Humira for Crohn's disease, rheumatoid arthritis and psoriatic arthritis. ("Hate psoriasis? Love clearer skin," says an ad on the Humira Web site featuring a pretty woman.) And earlier this year Prolia was approved by the FDA for postmenopausal osteoporosis with a high risk of fracture. Do healthy people really want to suppress their body's tumor necrosis factor (TNF) and invite tuberculosis, serious, possibly lethal infections, melanoma, lymphoma and "unusual cancers in children and teenagers" as the Humira label warns? Nor is it clear these drugs work. The Humira label warns against developing "new or worsening" psoriasis -- a condition it is supposed to treat.


-- Chantix
How unsafe is the antismoking drug Chantix? After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal acts, thoughts or behaviors and 28 suicides, the government banned pilots and air traffic controllers and interstate truck and bus drivers from taking Chantix in 2008. Four months later, some military pharmacies banned the drug, which reduces both cravings and smoking pleasure. In addition to Chantix' neuropsychiatric effects (immortalized by New Bohemians musician Carter Albrecht, who was shot to death in 2007 in Texas by a neighbor after acting aggressively), Chantix is linked to angioedema, serious skin reactions, visual impairment, accidental injury, dizziness, muscle spasms, seizures and loss of consciousness. In defending an increasingly indefensible drug, Janet Woodcock, director of the FDA Center for Drug Evaluation said last year, "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit." True enough -- but if you smoke cigarettes you can still drive an interstate truck.

-- Ambien
Sleeping pills like Ambien, Lunesta, Sonata and Rozerem only decrease get-to-sleep time by 18 minutes according to the National Institutes of Health (NIH).

But Ambien has additional cachet compared to its soporific brethren: it is the drug Tiger Woods reportedly used when cavorting with his consorts; and former U.S. Rep. Patrick Kennedy was taking it when he crashed his Ford Mustang while driving to Capitol Hill in the middle of the night to "vote" in 2006.

In fact Ambien's legendary somnambulism side effects -- people walk, drive, make phone calls and even have sex while sleeping -- has increased traffic accidents say law enforcement officials, with some drivers not even recognizing arresting police. Thanks to bad Ambien press, Sanofi-Aventis has had to run ads telling the public to get in bed and stay there if you are going to take Ambien. (Or you'll break out in handcuffs, as the joke goes.) Ambien has also increased the national weight problem as dieters wake up amid mountains of pizza, Krispy Kreme and Häagen-Dazs cartons consumed by their evil twins.

-- Tamoxifen

Is it a coincidence that Tamoxifen maker AstraZenaca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? Both the original safety studies of Tamoxifen, which causes cancer, birth defects and is a chemical cousin of organochlorine pesticides, and its original marketing were riddled with scientific error. In fact, FDA objected to AstraZeneca's marketing claim of breast cancer prevention and the casting of endometrial cancer as an "uncommon" event 10 years ago.

Yet today pharma-linked doctors still tell women to take Tamoxifen to prevent breast cancer even though an American Journal of Medicine study found the average life expectancy increase is nine days (and Public Citizen says for every case of breast cancer Tamoxifen prevents there is a life-threatening case of blood clots, stroke or endometrial cancer). A Gynecologic and Obstetric Investigation study shows an example of Tamoxifen's downside: 57.2 percent of women on continuous Tamoxifen developed atrophy of the lining of the uterus, 35.7 coexisting hyperphasia and 8.1 percent uterine polyps. We won't even talk about eye and memory problems -- or the Tamoxifen cousin, Evista, that pharma is also pushing which has a "death from stroke" warning on its label.

-- Boniva
Why is the bisphosphonate bone drug Boniva available in a convenient, once-monthly formulation? Could patients balk at the fact that after you take it you have to avoid lying down for at least 60 minutes to "help decrease the risk of problems in the esophagus and stomach," wait at least 60 minutes before eating or drinking anything except water, never take it with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins, and of course, "do not chew or suck"? Nor should you take Boniva, say the warnings, "if you have difficult or painful swallowing, chest pain or continuing or severe heartburn, have low blood calcium or severe kidney disease or if severe bone, joint and/or muscle pain."

Bone drugs like Boniva, Fosamax and Actonel are a good example of FDA approving once-unapprovable drugs by transferring risk onto the public's shoulders with "we warned you" labels. The warnings are supposed to make people make their own safety decisions. Except that people just think FDA wouldn't have approved it if it weren't safe.


-- Prempro and Premarin
You'd think Pfizer's hormone drugs Prempro and the related Premarin and Provera would be history in light of their perks: 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease, double the rates of blood clots and links to deafness, urinary incontinence, cataracts, gout, joint degeneration, asthma, lupus, scleroderma, dementia, Alzheimer's disease and lung, ovarian, breast, endometrial, gall bladder and melanoma cancers -- pant pant. But you'd be wrong. Even as we speak, Pfizer-linked researchers are testing the cognitive and cardiovascular "benefits" of hormone therapy, in some cases with our tax dollars, at major universities. Even though the cancer rate in the U.S. and Canada fell when women quit hormone therapy in 2002 (as did the U.S. heart attack rate in women), pharma is rolling out HT "Light" for women who suffer from the "ism" of incredibly short memory.

Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You

To say that Pfizer has been accused of wrongdoing is like saying BP had an oil spill.
By Martha Rosenberg, AlterNet
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.

Worse, it bought Warner-Lambert in 2000, which made Neurontin, knowing the drug's marketing practices were under criminal investigation. (And knowing its Rezulin had been withdrawn.)

And even as it entered into its 2004 CIA for Neurontin, it was off-label marketing the seizure drug Lyrica, called Son of Neurontin, and three other meds, and had to enter into a third CIA, last year's $2.3 billion Bextra settlement which was the largest health care fraud settlement in US history.

The same day the settlement news broke, Pfizer announced it bought the drug giant Wyeth despite its thicket of Fen-Phen heart valve suits and Prempro cancer suits.

And there was more "bring 'em on" chutzpah.

After Vioxx and Pfizer's Bextra were withdrawn from the market for cardiovascular risks, Pfizer sought FDA approval for its Celebrex, the last legal COX-2 inhibitor, also suspected of cardiovascular risks, for use in children as young as two.

And in June, days before Pfizer suspended development of the osteoarthritis drug tanezumab for worsening joints, it touted the drug as "well-tolerated."

As a company, Pfizer, based in New York City with research headquarters in Groton, CT, looks better from the outside than the inside. Its Pac-Man like acquisition of drug companies, Warner-Lambert, Pharmacia (Searle, Upjohn), SUGEN, Vicuron, Rinat and Wyeth (also creating the world's biggest animal drug company) has created a silo structure in which the company's 90,000 employees in 90 countries feel unconnected to a corporate heartbeat. Loyalty is rare as employees in absorbed companies bought for their products alone fear getting pfired and 14,000 scientists bemoan that the company's biggies like Lipitor, Celebrex, Neurontin, Zithromax, Zyrtec and now Wyeth's Prempro weren't created inhouse.

Despite flying doctors to Caribbean resorts to attend drug pitches (by other paid doctors) and bestowing four figure honorariums on them, and Enron moments like a Bextra sales extravaganza with acrobats, dancers and gigantic "fist" logo, Pfizer's Midtown Manhattan offices consist of unimpressive cubes.

After becoming the world's biggest drug company in 2000, Henry A. McKinnell, former Pfizer CEO and a Bushmate (replaced by less conservative Jeffrey B. Kindler) vowed to make Pfizer the "the world's most valued company to patients, to customers, to business partners, to colleagues, and to communities where we work and live." But thanks to the parade of damaging safety and ethics scandals, Esprit de corps is lacking except in some sales units.

"Pfizer is a black hole," Peter Rost, MD, author of The Whistleblower: Confessions of a Healthcare Hitman and probably Pfizer's most famous former employee told AlterNet. "It is nothing but a maze of cobbled together drug companies that aggressively markets drugs it didn't create in a military-like command structure."

Still, Pfizer's vast product line, its $50 billion a year revenues -- exceeding some states' entire budgets -- and reputation for having the best trained sales reps make it the team to beat for competing salesmen and examples of Pfizer envy dot Cafepharma, the drug industry chatroom considered pharma's washroom wall.

"Glad they did it," wrote a poster about last year's Department of Justice (DOJ) Bextra settlement. "Pfizer is only sticking it to the American person when they perpitrate a fruad (sic) of this magnitude. The rest of you who sat by and said nothing are no better than a bunch of crooks. My father always said, 'you lie, you cheat, you steal; you can't do one without doing them all'. You must be so proud...I would take that name badge off when I walk into an office if I were you."

"If you think that Pfizer is the only drug company that has dealt with off-label promotion issues you are sadley (sic) mistaken," perpitrated the next poster.

"You are so right. All the other companies are doing it, so we did too. Waaah, waaah, waaaaah! (stomping my foot). It's not fair! It made us so much money! Patients don't matter, money does," wrote the next poster. Characterizations about wives and mothers followed.

Patients also resent Pfizer and have sued over Chantix, Lipitor, Celebrex, Bextra, Neurontin, Lyrica, Viagra, Zoloft and other drugs. Pfizer downplayed Lipitor's "serious and irreversible side effects" says Mark Jay Krum, an attorney representing plaintiffs in a class-action suit, and "is willing to promote the drug at any cost." Say that.

Even the DOJ calls Pfizer incorrigible. "...illegal conduct was pervasive throughout the company and stemmed from messages created at high levels within the national marketing team," it wrote in the Bextra sentencing memo. "Employees, including district managers, explained that they did not question their supervisors about the illegal conduct that they were being instructed to carry out, because to do so would be considered a 'CLM' or 'Career Limiting Move.'"

Still the FDA needs to take some blame for waving iffy Pfizer drugs through, especially under the 1992 Prescription Drug User Fee Act (PDUFA) in which drug companies "buy" accelerated approvals.

Why did the FDA allow Pfizer to make money for ten years on the leukemia drug Mylotarg, which was given an accelerated approval, and allow people to take it as guinea pigs for ten years while "confirmatory" studies establishing its safety and efficacy were still outstanding? Patients who took Mylotarg while on chemotherapy had more deaths than those just on chemotherapy in a clear example of the lethal metrics of rushed through drugs.

Why was Pfizer's pain drug tanezumab, an injected monoclonal antibody made from bio-engineered immune cells, even considered for knee pain except for the profits in such Frakendrugs?

Why was Pfizer allowed to continue clinical trials on children, or anyone, after the FDA found Geodon overdoses in April -- and why is Geodon, rejected once by the FDA and promoted by Richard Borison MD who is in Hancock State Prison for research fraud -- hello -- on the market? Obama appointees Commissioner Margaret Hamburg, MD and principal deputy commissioner Joshua Sharfstein, MD come from public health backgrounds but it will be hard to turn the FDA ship around.

And speaking of dangerous drugs, what's up with Pfizer's anti-smoking drug Chantix?

In 2007, Texas musician Carter Albrecht, who played with Sorta and Edie Brickell & New Bohemians, became a poster boy for Chantix' unpredictable mental effects when he was fatally shot trying to kick in a neighbor's door. In 2008, with 988 adverse effects reported including seizures, heart trouble and suicides, the FDA banned airline pilots and air traffic controllers from taking it. Thanks for that. Last year it gave Chantix a black box warning to "highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs."

Most pharma watchers agree that financial penalties, including last year's $2.3 billion Bextra settlement, won't upend Pfizer whose one year budget for R & D alone is in the billions. Yet the DOJ repeatedly lets Pfizer pawn off guilty pleas to the False Claims Act (which include a ban on Medicare, Medicaid and VA eligibility) on its shell companies and keep doing business with the government. Why?

"Pfizer is the largest drug company in the world and if you include its generics unit it makes literally hundreds of different drugs. Getting tough would mean no Lipitor, no Viagra, no Bacitracin, no Cipro, no Zithromax, no Sutent, et cetera," says Jim Edwards, a pharmaceutical reporter on Bnet and former managing editor of Adweek. "The government is not really in a position to be cutting itself off from all that medicine."

"So many Medicaid, Medicare and VA drugs come from Pfizer, the government would never convict them," agrees Peter Rost. "It would stop the drug flow."

And then there's lobby power.

Just as former Louisiana Republican representative Billy Tauzin left the House Committee on Energy and Commerce which oversees the drug industry and resurfaced as head of PhRMA, Pfizer recently hired Gregory Simon who served on Obama's transition team and as chief domestic policy advisor to Vice President Gore to head its "global policy effort." Its senior corporate counsel until 2008, Arnold Friede, had an FDA background and Pfizer's former senior vice president for worldwide public affairs, Richard Bagger, has re-emerged as New Jersey Governor Christopher Christie's chief of staff. Hey, you guys look familiar!

Even the Bextra settlement arouses cynicism since $102 million of it went to a doctor and five former Pfizer reps who served as whistleblowers on the case, one getting $51 million.

Isn't making big money off pharma how the trouble started?