Posts Tagged ‘black box warning’

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Child/Teen Suicide Rate 5 Times Higher for Kids on Antidepressants; Researchers Say findings support FDA Black Box Warnings

Monday, April 12th, 2010

WebMD
By Jennifer Warner
April 12, 2010

The heightened risk of teen suicide doesn’t vary among users of different antidepressants, a new study finds.

Researchers say the finding supports the FDA’s current “black box” warning on all antidepressants detailing the increased risk of suicide attempts and suicides in children and teens who start to take the drugs. A “black box” warning is the FDA’s most severe warning label.

Previous studies have shown that children and teenagers who begin to use SSRI (selective serotonin reuptake inhibitor) antidepressants may have an increase in suicidal thoughts and behaviors, but researchers say this is the first study to compare the child and teen suicide risk among different individual SSRI antidepressants.

The study followed 20,906 children in British Columbia between the ages of 10 and 18 who had been diagnosed with depression and prescribed an antidepressant over a nine-year period.

During the first year of antidepressant use, there were 266 attempted suicides and three suicides.

Researchers found no significant difference in child and teen suicide risk among the five SSRI antidepressants studied (fluoxetine, fluvoxamine, citalopram, paroxetine, and sertraline). Tricyclic antidepressants showed risks similar to the SSRIs.

Overall, the child and teen suicide rate after initiation of antidepressant use among participants in the study was five times higher than the rate reported among all teens aged 13 to 17 in British Columbia, which researchers say reflects the higher suicide risks among the depressed.

“Our analysis supports the decision of the Food and Drug Administration to include all antidepressants in the black box warning regarding increased suicidality risk for children and adolescents initiating use of antidepressants,” write researcher Sebastian Schneeweiss, MD, ScD of Harvard Medical School and colleagues in Pediatrics.

Read entire article:  http://www.webmd.com/depression/news/20100412/teen-suicide-risk-similar-among-antidepressants

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Kickbackers’ motto: ‘Do no harm’ (to profits)—How drug company used kickbacks to get patients on psych drugs

Tuesday, January 26th, 2010

Boston Globe
By Donald A. MacGillis
January 26, 2010

TALK ABOUT death panels. The US attorney in Boston recently filed suit against the world’s largest maker of health products, Johnson & Johnson, for using kickbacks to get more nursing home patients onto its drugs, including one that was later found to be so lethal to the elderly it had to carry a black-box warning. The government’s complaint leaves little doubt that the drug company acted in a predatory way to increase sales and market share for its products, especially Risperdal, an antipsychotic often used to keep Alzheimer’s and dementia patients under control.

Risperdal is used principally for the treatment of schizophrenia and bipolar disorder. Doping the elderly into placidity is an off-label use of the drug, one that the Food and Drug Administration finally cautioned against in 2005. The reason for the black box warning the FDA required? Too many of the elderly who got the drug were dying.

There is one other reason to thank the federal government for going after the suspect payments Johnson & Johnson made to the middleman to juice up sales of its drugs: Since Medicaid covers most of the nursing home patients, the taxpayer ends up paying much of the bill.

The middleman between Johnson & Johnson and the nursing homes is Omnicare, the country’s largest pharmacy for nursing homes. Last November, it agreed, without “any finding of wrongdoing’’ or “any admission of liability,’’ to a $98 million settlement with the government for its role in helping Johnson & Johnson boost sales to nursing homes. The government says that between 1999 and 2004 Omnicare received tens of millions of dollars in the form of escalating rebates based on greater market share for Johnson & Johnson drugs and in payments ostensibly made by Johnson & Johnson for “data’’ from Omnicare, much of which Omnicare never provided. Other kickbacks, the government says, came in the form of “grants’’ and “educational funding.’’

Read entire article:  http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/01/26/kickbackers_motto_do_no_harm_to_profits/

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FDA misleads again: Admits SSRI/suicide link for 25 & under but not adults

Thursday, August 13th, 2009

Julie Steenhuysen
Reuters
August 11, 2009

* Antidepressants raise suicide risks in young adults

* Older adults not affected, US FDA regulators find

CHICAGO, Aug 11 (Reuters) – People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.

The report by the FDA scientists confirms earlier studies and supports the agency’s age-related warnings on the drugs’ labeling.

U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.

In February 2005, the FDA added a so-called black box warning — the agency’s strongest warning — on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.

Read entire article: http://www.reuters.com/article/latestCrisis/idUSN11535486

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Suicide Prevention Drug Pushing Racket: Drug company shills publish bogus studies to promote antidepressants

Thursday, August 6th, 2009

Evelyn Pringle
Natural News
August 6, 2009

Nearly every year, as part of the suicide prevention drug pushing racket, drug company shills publish a bogus study with claims that more people are dying from suicide due to a black box warning of an increased risk of suicide in young people on the labels of SSRI and SNRI antidepressants.

Although the FDA did announce that the black box warnings, for children under 18, would be added to antidepressants in October 2004, the warnings were not on the labels until the spring of 2005. The extended warnings, to include young persons through age 24, were not added until mid-2007.

This year’s bogus study was announced on June 2, 2009, with a WebMD headline asking: “Are Antidepressant Warnings Causing Harm?” The study titled, “Persisting Decline in Depression Treatment After FDA Warnings,” was published in the “Archives of General Psychiatry,” with claims that there has been a drastic drop in the diagnosis of depression in both children and adults.

“Policy actions are required to counter the unintended consequences of reduced depression treatment,” the authors wrote in the study.

Prescriptions written for antidepressants also have dropped significantly, and these “unintended” consequences of the FDA’s warnings are continuing, the junk science co-author of the study, Robert Valuck, PhD, of the University of Colorado Denver’s School of Medicine, told WebMD.

Read entire article:  http://www.naturalnews.com/026789_suicide_suicide_prevention_Eli_Lilly.html

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Antidepressant use in U.S. has almost doubled with 10% of people over 6 taking antidepressants

Monday, August 3rd, 2009

Amanda Gardner
HealthDay Reporter
August 3, 2009

Antidepressant use among U.S. residents almost doubled between 1996 and 2005, along with a concurrent rise in the use of other psychotropic medications, a new report shows.

The increase seemed to span virtually all demographic groups.

“Over 10 percent of people over the age of 6 were receiving anti-depression medication. That strikes me as significant,” said study author Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University/New York State Psychiatric Institute in New York City.

According to background information in the study, antidepressants are now the most widely prescribed class of drugs in the United States. The expansion in use dates back to the 1980s, with the introduction of the antidepressant Prozac (fluoxetine).

The study found that 5.84 percent of U.S. residents aged 6 and over were using antidepressants in 1996, compared with 10.12 percent in 2005. That’s 13.3 million people, up to 27 million people.

“This is a 20-year trend and it’s very powerful,” remarked Dr. Eric Caine, chair of the department of psychiatry and co-director of the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center.

This happened despite a “black box” warning mandated for many antidepressant medications by the U.S. Food and Drug Administration in 2004, the study authors noted.

Read entire article:  http://health.usnews.com/articles/health/healthday/2009/08/03/antidepressant-use-in-us-has-almost-doubled.html

Posted August 3, 2009

By Amanda Gardner
HealthDay Reporter

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