Seroquel’s Toll

Controversial Pill Now Marketed for Depression

By MARTHA ROSENBERG

Even though AstraZeneca’s antipsychotic Seroquel is the fifth best-selling medication in the US according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and Advair diskus, its safety, effectiveness, clinical trial and promotion records are highly checkered.

An original backer, psychiatrist Richard Borison, was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme.

Its US medical director Wayne MacFadden had sexual affairs with two different women involved with Seroquel research, say published reports.

Chicago psychiatrist Michael Reinstein received $500,000 from AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the Chicago Tribune and ProPublica.

Psychiatrist Charles Nemeroff who left Emory University in disgrace after a Congressional investigation for unreported pharma income, promoted Seroquel in continuing medical education courses according to the web site of psychiatrist Daniel Carlat.

Florida child psychiatrist Jorge Armenteros was chairman of the FDA committee responsible for recommending Seroquel approvals while a paid AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.

Psychiatrist Charles Schulz’ high profile pro-Seroquel presentations are suspected of being colored by his AstraZeneca income says the Minneapolis Star Tribune.

And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.

Originally approved for schizophrenia in 1997, Seroquel has subsequently been approved for bipolar disorder, for some groups of kids and as an add-drug for depression. This “indications creep” has mostly flown below the public’s radar. Seroquel expansion to treat children in late 2009, for example, was noted as a mere “label change” on the FDA web site. Hello?

Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina’s Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.

But now, as AstraZeneca rolls out its “Still Trying to Get Ahead of Your Depression” campaign, there are new questions about Seroquel’s safety and effectiveness.

According to an FDA warning letter, an AstraZeneca sales representative during an unsolicited sales call on January 3, 2008 sold Seroquel as a treatment for major depressive disorder to a physician before it was approved for MDD, an infraction which is illegal.

Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for patients with major depressive disorder who not have an adequate response to antidepressant therapy), its leave-behind sheets drew another FDA warning letter.

AstraZeneca implied patients would achieve “remission” from depression with Seroquel XR (extended release) as opposed to with an antidepressant alone, says FDA — a claim not backed up by clinical experience.

Seroquel’s effect on depression has only been demonstrated in two, six-week trials FDA further said and six weeks is “not a long enough time period to adequately assess remission.” (It was approved…why?)

Also the case study of “Catherine F.” depicted in leave-behind sheets is inaccurate says FDA because it suggests Seroquel alleviates “symptoms of sadness and loss of interest when this has not been demonstrated by substantial evidence or substantial clinical experience.” (It was approved…why?)

Even AstraZeneca’s own briefing to the FDA committee in 2009 admits a “failed study” in which both Seroquel and Lexapro “failed to differentiate from placebo” which is Clinical Trial for “didn’t work.”

Nor did AstraZeneca adequately disclose Seroquel risks says FDA which include increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.

In fact, in addition to risks like cataracts, seizures and increases in blood pressure in children and adolescents, already on the Seroquel label, FDA asked AstraZeneca to add the “risk of EPS and withdrawal syndrome in neonates” a few months ago: movement disorders which can affect mothers’ babies if the mothers are taking Seroquel and stop.

But the FDA might also look at what the government’s other hand is doing. In May the Office of the Army Surgeon General’s final report on the findings of its Pain Management Task Force unabashedly hawks Seroquel for an unapproved use.

“Physicians should consider these medications for sleep disorders,” says the 163-page report,” listing Ambien and Seroquel (quetiapine) “for nightmares” even though Seroquel has never been approved for insomnia, sleep disorders or “nightmares.”

Maybe the government will send itself a warning letter.

Martha Rosenberg can be reached at: martharosenberg@sbcglobal.net

This article was re-printed with permission from Martha Rosenberg.

Study Reveals Top Ten Violence-Inducing Prescription Drugs [– Eight Are Psychiatric Drugs]

By Ethan A. Huff

(NaturalNews) The Institute for Safe Medication Practices (ISMP) recently published a study in the journal PLoS One highlighting the worst prescription drug offenders that cause patients to become violent. Among the top-ten most dangerous are the antidepressants Pristiq (desvenlafaxine), Paxil (paroxetine) and Prozac (fluoxetine).

Concerns about the extreme negative side effects of many popular antidepressant and antipsychotic drugs have been on the rise, as these drugs not only cause severe health problems to users, but also pose a significant threat to society. The ISMP report indicates that, according to the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System, many popular drugs are linked even to homicides.

Most of the drugs in the top ten most dangerous are antidepressants, but also included are an insomnia medication, an attention-deficit hyperactivity disorder (ADHD) drug, a malaria drug and an anti-smoking medication.

As reported in Time, the top ten list is as follows:

10. Desvenlafaxine (Pristiq) – An antidepressant that affects serotonin and noradrenaline. The drug is 7.9 times more likely to be associated with violence than other drugs.

9. Venlafaxine (Effexor) – An antidepressant that treats anxiety disorders. The drug is 8.3 times more likely to be associated with violence than other drugs.

8. Fluvoxamine (Luvox) – A selective serotonin reuptake inhibitor (SSRI) drug that is 8.4 times more likely to be associated with violence than other drugs.

7. Triazolam (Halcion) – A benzodiazepine drug for insomnia that is 8.7 times more likely to be associated with violence than other drugs.

6. Atomoxetine (Strattera) – An ADHD drug that is 9 times more likely to be associated with violence than other drugs.

5. Mefoquine (Lariam) – A malaria drug that is 9.5 times more likely to be associated with violence than other drugs.

4. Amphetamines – This general class of ADHD drug is 9.6 times more likely to be associated with violence than other drugs.

3. Paroxetine (Paxil) – An SSRI antidepressant drug that is 10.3 times more likely to be associated with violence than other drugs. It is also linked to severe withdrawal symptoms and birth defects.

2. Fluoxetine (Prozac) – A popular SSRI antidepressant drug that is 10.9 times more likely to be associated with violence than other drugs.

1. Varenicline (Chantix) – An anti-smoking drug that is a shocking 18 times more likely to be associated with violence than other drugs.


This article was re-printed with permission from Natural News Reader Service. You can read it here: Natural News

Note from CCHR: For an in-depth look at the link between psychiatric drugs and school shootings watch the Fox National News Exposé, Deadly Drugs

Diet is Strongly Associated with the Risk of Depression

A team of researchers from England and France found that dietary patterns over a five-year period had a significant effect on the risk of feeling depressed.  People eating a predominantly natural-foods diet of mostly vegetables, fruits, fish, and whole grains were one-fourth less likely to have depression.  Those eating mainly processed foods, including processed meats, refined grains, fried foods, high-fat dairy products, and sweetened desserts were more than 50 percent more likely to feel depressed.  The natural-foods diet is richer in vitamins, minerals, and good fats that help maintain healthy moods.  (Akbaraly TN, Brunner EJ, Ferrie JE, et al.  Dietary pattern and depressive symptoms in middle age.  British Journal of Psychiatry, 2009;195:408-413)

Increased Blood Clot Risk with Antipsychotic Drugs

Scientists in the UK believe that antipsychotic drugs raise the risks of dangerous blood clots

This risk had already been spotted by some scientists and seems now to be confirmed by a new study. Almost 16,000 people suffered a deep vein thrombosis (formation of a blood clot in a deep vein) and 9,000 people suffered a clot in the lung.

Study subjects taking newer “atypical” antipsychotics had a 73% higher chance of developing a clot, reports BBC News.

Other studies have already revealed a higher stroke risk among patients taking antipsychotics.

For more information on psychiatric drugs, visit CCHR’s Psychiatric Drug Side Effects search engine.