Posts Tagged ‘celexa’

Antidepressant Drugs Are Not Safe During Pregnancy—No Matter What the Pharma Shills Say

Thursday, November 4th, 2010

by CCHR International

November 4, 2010

Medical News Today published an article entitled “Increased Depression Screening Needed During Pregnancy, Study Says,” that is so highly misleading,  we wonder if they ever bother checking the validity of what they’re forwarding under the guise of “medical news.”

We’re going to make this really simple—the study and its findings are bogus not to mention highly misleading and we’re only going to take up the two most egregious “facts” of the article to make our point.

The article states, “The authors of the study say their findings suggest that screening for depression should be a routine part of prenatal and postnatal care.  They conducted a 10-week pilot project at WIC clinics in Santa Fe and Las Vegas, N.M., finding that 109 of 467 women who were screened had a high enough score on the Edinburgh Postnatal Depression Scale to require a referral.”

FACT: The Edinburgh Postnatal Depression Scalealso called EPDS, is a screening method documented to triple the number of women diagnosed with Post partum depression, according to a study published in Obstecrics & Gynecology. The Scandinavian Journal of Public Health stated that EPDS screening was so unethical it should not be used.

So the authors are knowingly promoting a study which is known to triple the amount of women diagnosed postpartum depression,  has been called so unethical it should not be used.

Next, the article states, “There are antidepressants that are safe to take during pregnancy”

False.

FACT: Four countries have done nine studies on the effects of antidepressants during pregnancy or breast feeding.  They found that newer and older antidepressants can cause premature births, and increase the risk of cardiovascular interventions such as heart surgery in early childhood.  In addition, newer antidepressants could also cause withdrawal symptoms, respiratory problems, and neurological problems.

Six counties have issued a total of 15 drug regulatory warnings on antidepressants causing severe problems for newborns.

They warn of:

  • Newer antidepressants causing seizures,
  • Wellbutrin, Cipralex, Luvox, Remeron, Effexor and Zyban increasing the risk of a life-threatening lung condition in newborns,
  • Zoloft and Celexa causing withdrawal symptoms and increasing the risk of a life-threatening lung condition in newborns,
  • Paxil and Prozac causing withdrawal symptoms and increasing the risk of cardiovascular birth defects and a life-threatening lung condition in newborns

Like we said, the article and the “findings” are highly misleading to say the least.

We’d also like to suggest something to any press forwarding these psycho/pharma puff pieces— Its called Google Search.   Its pretty easy these days to check the facts before promoting bogus studies and or “findings”  that are not only false, but can harm pregnant women and can give false information under the guise of “medical news.”   We also recommend that anyone reporting on psychiatric drugs at least check  our psychiatric drug database to see what international drug regulatory agencies and international studies have warned about these drugs instead of just regurgitating the latest pro drug study http://www.cchrint.org/psychdrugdangers/

Here is  a very short video of what can happen to pregnant women when they are not given the facts about these drugs:

In Memory of Matthew Schultz / Effexor Baby Pregnancy Infant Death

http://www.youtube.com/watch?v=qnxuw2ufSug&p=7F22F2C419977E5A&playnext=1&index=70

And finally, the “Medical News” article:

Increased Depression Screening Needed During Pregnancy, Study Says

Medical News Today

Twenty-three percent of pregnant women screened at two Women, Infant and Children clinics in New Mexico met criteria for depression, according to a study by a work group of the New Mexico Health Department and state Human Services Department, the Albuquerque Journal reports.

Nationwide, 10% to 16% of pregnant women meet the criteria for depression, and 70% show some depressive symptoms, according to the American College of Obstetrics and Gynecologists.  In June, ACOG said that screening of pregnant women for depression should be “strongly considered” but that there is not enough evidence to recommend it.

The authors of the new study say their findings suggest that screening for depression should be a routine part of prenatal and postnatal care. They conducted a 10-week pilot project at WIC clinics in Santa Fe and Las Vegas, N.M., finding that 109 of 467 women who were screened had a high enough score on the Edinburgh Postnatal Depression Scale to require a referral. The work group recommended increased training on depression screening tools for providers and more support groups for women, in both English and Spanish.

Signs of depression in pregnant women include feeling dread about the pregnancy, anxiety, isolation from loved ones, suicidal thoughts, self-harm, constant sadness, changes in appetite and lack of ability to experience pleasure, according to therapist Stefanie Luna. Doctors say leaving severe depression untreated could increase the risk for low birthweight or premature birth. When women are depressed they also are less likely to care for themselves and more likely to drink or smoke. There are antidepressants that are safe to take during pregnancy (Schoenberg, Albuquerque Journal, 11/1).

http://www.medicalnewstoday.com/articles/206701.php

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Forest Labs settling wrongful death & personal injury lawsuits from parents of kids who took Celexa & Lexapro

Monday, November 1st, 2010

Stltoday.com

by Jim Doyle

A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug’s clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.

Four of the cases were settled Friday, and two additional cases were settled in recent weeks.

A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.

Last month, the company’s subsidiary — Forest Pharmaceuticals, based in Earth City — agreed to plead guilty to criminal charges involving its marketing and manufacturing practices and also to pay more than $300 million in criminal and civil penalties. The U.S. attorney’s office in Boston is continuing to investigate the potential criminal liability of Forest officers and employees.

According to federal regulators, Forest waged an aggressive campaign from 1999 through at least 2005 to promote the use of Celexa and Lexapro in children and teenagers, although neither drug was approved for pediatric use.

Details of Forest Laboratories’ monetary settlements with aggrieved families have not been made public, but the lawsuits themselves present a glimpse of the alleged harm caused by the company, including hefty payments to pediatricians and other physicians to tout the benefits of the drugs.

In vivid detail, the complaints allege that children under the influence of Celexa and Lexapro committed acts of suicide and violence. And the victims’ families accuse the pharmaceutical company of fraud and negligence in failing to warn physicians and the public about the drugs’ known dangers.

But the settlements are cloaked in secrecy, with each side vowing not to disclose the dollar amounts paid or other aspects of their agreements.

Frank Murdolo, the chief spokesman for Forest Laboratories, was unavailable for comment.

Harris Pogust, a Pennsylvania attorney who is the plaintiffs’ lead counsel in the multidistrict litigation, said, “I can’t really discuss anything that’s going on between the parties.”

The Celexa and Lexapro cases have been consolidated in federal court in St. Louis.

Several years ago, some of Pogust’s clients testified before Congress and the Food and Drug Administration about the dangers of marketing the drugs to children.

One of the cases settled Friday involves Andrew Tradd of Massachusetts, who was 13 when he tried to hang himself in April 2004. Seven days later, he died as a result of a brain injury suffered in that attempted suicide. He had been prescribed Celexa in 2002.

According to his family’s lawsuit, Forest was aware through numerous studies that some patients taking Celexa and similar drugs were much more at risk of suicidal behavior but chose not to warn physicians or strengthen the warning on the drug’s packaging.

Celexa’s sales skyrocketed from $92 million in 1999 to $1.6 billion in 2002. But the firm was under pressure to sell as much of Celexa as possible because the U.S. patent on the drug would expire in 2004.

H. Lundbeck, a Danish firm that developed Celexa, had placed a suicide warning on the drug in Europe for many years but not in the United States — until a “black box” warning was mandated for Celexa and similar drugs in 2004 by the FDA.

The Tradd lawsuit and another suit quote Howard Solomon, the chairman and chief executive of Forest Laboratories, as saying in a letter to shareholders, “We believe that the studies and experience with our products, Lexapro and Celexa, do not indicate any increased suicidality.”

But the Tradd family alleged that “contrary to these claims, for years Forest Laboratories Inc., was aware of clinical trials that showed that some persons who took Celexa suffered damaging side affects including agitation, aggressive and suicidal tendencies.”

Another settled case involves Rachel Weiss of Belchertown, Mass., who was 16 in November 2002 when she suffered a panic attack while at school. En route to the school nurse’s office, her suit alleges, Rachel threw herself down concrete and metal stairs, causing permanent injuries to her back and spine.

A high school sophomore, she had been taking Celexa for about nine days for depression and anxiety. After she began taking Celexa, the suit alleges, “her symptoms worsened dramatically.”

In 2002, a four-year clinical trial by the Danish Lundbeck firm revealed that Celexa did not help depressed adolescents more than a placebo. But the results were not made public until 2004, when they appeared on a single line of a chart contained in a Danish textbook, the suit alleges.

The U.S. attorney’s office in Boston has asserted that the results of the Lundbeck trial had been provided to Forest two years earlier, but the company chose to keep the negative results hidden from the public.

Another settled case involved Danielle Henrikson, who was 15 when she hanged herself in the garage of her parents’ Idaho home in July 2004. Within a few weeks after taking Celexa, their lawsuit alleges, her condition began to deteriorate.

“The company suppressed the negative results of some studies, which showed that Celexa could cause an increased risk of suicidal thinking and acts in those adolescents who were prescribed to it,” the suit alleges.

Forest Laboratories denied the allegation in court documents.

A case settled Friday was on behalf of Alex Kim of Gwinnett County, Ga., who hanged himself in June 2004 when he was 13 after his Lexapro dosage had been doubled. He had been taking the drug for about three months.

In their lawsuit, Alex’s parents asked for $10 million in general damages, plus $10 million in punitive damages from Forest for “failing to provide information regarding serious health risks, failing to publicize the risks, failing to timely alert the public, and failing to recall the product.”

Read the rest of the article here: http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html

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$1,000 a Pop: How Forest Labs Bribed Doctors to Prescribe Antidepressants to Kids

Thursday, September 16th, 2010

BNET

By Jim Edwards | September 15, 2010

Forest Labs (FRX) appears to have initially underestimated how much it needed to pay the feds to go away: In 2009, the company said it had set aside $170 million in case it needed to settle a Department of Justice investigation of the kickbacks it paid in its marketing of Celexa and Lexapro, two antidepressants. Today, the company paid $313 million to wrap up the probes.

Forest’s management is used to lavish spending, however, as the whistleblower complaints behind the settlement allege.

The meat of Forest’s wrongdoing is that the company promoted Celexa for children even though the FDA had specifically rejected the drug for kids, and even though European data showed it was not useful in youths. The company did something similar with Lexapro — one pharmaceutical sales rep recommended crushing up Lexapro into apple sauce in order to make it more palatable to children.

Forest overcame resistance to the pediatric use of its antidepressants by bribing doctors with cash and gifts, the lawsuits alleged. Among the goodies Forest handed out were:

  • Tickets to St. Louis Cardinals games.
  • A $1,000 certificate to Alain Ducasse, one of the best (and most expensive) restaurants in New York, according to this suit.
  • A trip to see a George Carlin concert. (They’re antidepressants and he’s funny, geddit?).
  • $1,000 in cash to attend dinner at the Doral Park Country Club in Miami.
  • A trip to the Great Escape amusement park in New York.
  • Tickets to The Nutcracker at the Paper Mill Playhouse in Millburn, N.J., according to this suit.

The settlement, in which Forest pleads guilty to the accusations against it, also implies that one unnamed Forest executive lied to Congress in September 2004 — which is in itself a crime.

Read the rest of the article here: http://www.bnet.com/blog/drug-business/1000-a-pop-how-forest-labs-bribed-doctors-to-prescribe-antidepressants-to-kids/5753

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Forest Labs will pay $313 mil to settle criminal &civil charges that it improperly marketed antidepressants for use in children & distributed unapproved thyroid drug

Wednesday, September 15th, 2010

The Wall Street Journal by Brent Kendall

WASHINGTON (Dow Jones)–Forest Laboratories Inc. (FRX) will pay $313 million to settle criminal and civil charges that it improperly marketed antidepressants for use in children and distributed an unapproved thyroid drug, the Justice Department announced Wednesday.

The New York-based drug maker had previously announced a settlement in principle with the department, and said in July that the full cost of the pact would be covered by a reserve it had created.

The department said a Forest Labs subsidiary, Forest Pharmaceuticals Inc., would plead guilty to a felony charge of obstruction of justice, and misdemeanor charges related to the distribution of the thyroid drug Levothroid, which at the time was an unapproved new drug, and the illegal promotion of the antidepressant Celexa for use in treating children and adolescents.

The settlement also covers civil charges that Forest improperly promoted Celexa and another antidepressant, Lexapro, for pediatric use, which had not been approved by the Food and Drug Administration. Forest’s improper promotion campaign took place from 1998 until at least 2005, the department alleged.

It alleged that Forest misled doctors and consumers by failing to disclose a European medical study that determined Celexa was ineffective for pediatric use.

The civil case included other allegations that Forest paid kickbacks to encourage doctors to prescribe the antidepressants.

The Food and Drug Administration approved Lexapro last year for use in adolescents 12-17 years of age. That approval came after the time period covered by the legal case.

On the Levothroid charges, prosecutors said Forest Pharmaceuticals began distributing the thyroid drug in the early 1990s without first obtaining FDA approval. They said the subsidiary made a deliberate decision to continue distributing the unapproved drug in quantities far beyond what the FDA allowed during a phase-down period.

Prosecutors also said the company submitted inaccurate information to the FDA in its new drug application for Levothroid and obstructed an FDA regulatory inspection.

“Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the FDA and the American public,” Carmen Ortiz, the U.S. Attorney for Massachusetts, said in a statement.

Forest Chief Executive Howard Solomon said in a statement that the company was pleased to bring closure to the long-running investigation.

“We remain dedicated to ensuring that we operate in full compliance with all laws and regulations, and that our employees uphold the highest principles of integrity, honesty and ethics,” Solomon said.

While the Forest Pharmaceuticals subsidiary pleaded guilty to the criminal charges, Forest Labs said it denies the allegations being made in connection to the civil case.

As part of the settlement, Forest will pay a $150 million criminal fine and forfeit another $14 million in assets.

The company will pay roughly $149 million to settle the civil case.

It also entered into a five-year corporate integrity agreement that requires the drug maker to implement a compliance program and post information on its website about payments to doctors, such as honoraria, travel or lodging.

Lexapro is the company’s main money maker, with sales of $2.3 billion in fiscal year 2010.

Read the rest of the article here:  http://online.wsj.com/article/BT-CO-20100915-713619.html

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Psychotropic Drugs, Our Children and Our Pill-Crazed Society

Wednesday, September 8th, 2010

The Huffington Post
By Dr. Ronald Ricker and Dr. Venus Nicolino
September 8, 2010

Today, the use of psychoactive drugs by children (6-17) is all too common, relied on far too much and growing at an alarming rate. It all started in the ’70s.

Memorialized in 1966 by the Rolling Stones’ “Mothers Little Helpers,” it was at that time that our society took the first steps at becoming “Pill Crazy.” Valium and Librium and Quaaludes were “Mother’s Little Helpers. The first drugs to enter the stage. If you couldn’t stand Johnny, your friends, your husband, in-laws, etc, tranquilizers smoothed you out, made you tranquil. Not surprisingly, in the 70s, the consumption of these tranquilizers, once discovered and available, skyrocketed. Anxiety was the popular diagnosis. Antidepressants were beginning to raise their heads as well. Their popularity at that time, however, was muted by the fact that they didn’t work well, and also sported many side effects, some of which were very annoying and occasionally dangerous. And, no one knew what was just around the corner.

Prozac

Prozac was first marketed in 1987. It was a totally new type of antidepressant, which seemed to work and had far less side effects. What had been a stream of tranquilizers became a tsunami of Prozac’s and tranquilizers. Other ‘Prozac’s’ entered the scene–Zoloft, Celexa, Paxil and Luvox, all vying to take part of Prozac’s market share. Promotion of these drugs by drug manufacturers exploded. Where there had been a surge in the diagnosis of anxiety, now the diagnosis of the decade was ‘depression.’ Housewives by the droves needed and demanded antidepressants and even more tranquilizers. If one was good, two must be better. The pill craze was on.

Diagnoses started to morph. The more the diagnoses, the more opportunities to sell drugs. Anxiety became anxiety neurosis, panic disorder, panic attacks, etc. ‘Depression,’ as a diagnosis, was of course and remains very popular. However, many patients don’t and didn’t like that diagnosis–perhaps it sounded too much like a disease. So a new depression explanation and diagnosis emerged–’chemical imbalance,’ which sounded more sheik and less like a disease and, of course, yielded more customers.

Not far behind ‘chemical imbalance’ came ‘mood disorder,’ a special type of depression, also called bipolar disorder. There are people who actually have a bipolar disorder and require numerous special medications for treatment. These medications, mood stabilizers, antidepressants, and second generation antipsychotics are far more dangerous medications than Prozac and tranquilizers. Further, there are also many people who are said to have ‘bipolar disorder’ who don’t. Often these patients are those who were said to be depressed yet don’t get better with standard antidepressants. They get all the special and dangerous medications (the number of which is multiplying geometrically) and have the additional advantage of being able to excuse pretty much anything they do as a result of their ‘mood disorder.’

This pretty well takes us through the ’90s. But here come our children. How did our children get sucked into all this? Our pill craze was and is a huge part. Parents and physicians often subscribe to this theory, that there is a pill for everything. Mommy says Johnnie is depressed, doctor agrees, Johnnie doesn’t. Guess who wins? Certainly not Johnny. Guess what Johnnie gets? A pill, usually an SSRI, which he may end up taking for a long time. Assuming Johnnie takes three years of SSRI therapy, his diagnosis is changed 25 percent of the time, usually to the much more serious diagnosis, bipolar disorder. His medications are changed to a much more serious and dangerous types. If Johnny takes an SSRI for six years the chances of his diagnosis changing to bipolar increases to 50 percent. So do his meds.

There’s yet another and newer mine field for Johnnie to negotiate, new in the last two decades. Let’s say Johnnie fidgets in his seat, doesn’t listen to the teacher, hates to read, and talks to his neighbor all the time. Guess what. Johnnie is diagnosed with ADHD (attention deficit hyperactivity disorder) and given another serious type of drug, a stimulant–usually Ritalin or a form of speed (one example being Adderall). Did you know that Adderall is 100 percent speed? We know speed kills but give it to our children. Think about that. Speed kills and we give speed to our children, masked as Adderall.  Astounding.

Read entire article here:  http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/psychotropic-drugs-our-ch_b_680488.html

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Psych Meds Spike Among Younger Troops—The rise & potential dangers of psychiatric drug use a growing concern

Friday, September 3rd, 2010

The Navy Times

by Andrew Tilghman and Brendan McGarry
Friday Sep 3, 2010

Use of psychiatric medications among people ages 18 to 34 — mostly active-duty troops and their spouses — is rising at a significantly higher rate than other age groups in the military health care system, according to data newly released to Military Times.

Overall, the number of prescriptions filled for psychiatric medications rose 42 percent from 2005 to 2009 among Tricare beneficiaries in that age group, according to data provided by Tricare Management Activity in response to a Freedom of Information Act request.

That compares to an increase of 24 percent among Tricare beneficiaries ages 45 to 64, mostly retirees. For children 17 and younger, the increase was 18 percent.

All the increases outpace overall growth in the Tricare population over the same period.

Anti-depressants like Zoloft, Wellbutrin and Celexa account for slightly more than half of the prescriptions in this age group. But increasingly, young adults in the military and their spouses are turning to other types of psych meds to treat their mental health problems.

Prescriptions for stimulants, including amphetamines and drugs to treat attention-deficit disorders, more than doubled. And claims for anti-psychotics like Seroquel and Abilify nearly doubled from 2005 to 2009 among beneficiaries ages 18 to 34, the Tricare data show. Seroquel is often used to treat nightmares and sleeping problems related to post-traumatic stress disorder.

The rise — and potential dangers — of psychiatric drug use is a growing concern for many military officials and doctors.

The Army also should “conduct comprehensive research and analysis of the impact of increased use of antidepressant, psychiatric and narcotic pain management medications on the force,” the report said.

Last year, the Army issued a series of policies designed to reduce the risks linked to multi-drug use. Another policy is expected out later this year.

Military death records obtained by Military Times show that at least 68 accidental drug deaths in 2009, up from 24 in 2001. In total, at least 430 troops have died from drug use — or, in a small number of cases, alcohol use — in the past decade.

Read the rest of this article here:  http://www.navytimes.com/news/2010/09/military-psych-meds-080910/

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SSRIs Render Unfriendly Skies—FOIA documents reveal what FAA failed to consider in allowing pilots on antidepressants to fly

Wednesday, July 14th, 2010

Scoop Independent News
By Evelyn Pringle
July 14, 2010

The SSRI antidepressant makers are desperate to find new customers, so they recently have been focusing on capturing groups for which the drugs were usually considered off limits. The latest marketing coup managed to open up sales to roughly 614,000 American pilots.

Under a new policy announced on April 5, 2010, pilots diagnosed with depression can seek permission from the Federal Aviation Administration to take one of four SSRIs, including Eli Lilly’s Prozac, Pfizer’s Zoloft, and Forest Laboratories’ Celexa and Lexapro.

“The FAA should reverse its ruling before it’s too late and hundreds of lives are lost when a pilot becomes impulsive, suicidal or violent–or just loses his sharpness–under the influence of antidepressant medication,” said SSRI expert, Dr Peter Breggin, in an April 19, 2010 Huffington Post commentary.

The Citizens Commission on Human Rights is also calling on the FAA to rethink allowing pilots to take SSRI in light of a new report issued last month by the National Transportation Safety Board, on a February 1, 2008 plane crash in North Carolina, by a crazy acting pilot on Zoloft, that killed all six persons on board

The report said the pilot failed to maintain control of the plane during instrument flying conditions and “deliberately descended below the minimum descent altitude.” The plane stalled and crashed while circling after an aborted landing.

“Review of the cockpit voice recorder (CVR) audio revealed that the pilot had displayed some non-professional behavior before initiating the approach,” the NTSB reported.

The CVR recorded the pilot singing: “Save my life I’m going down for the last time,” before beginning a commentary in which he told passengers: “If anybody back there believes in the good Lord, I believe now would be a good time to hit your knees.”

A review of medical records documented that “from December 4, 2006 through December 31, 2007, the pilot had filled 6 prescriptions for 30 tablets of 50 mg sertraline (Zoloft),” the report said.

The records indicated that he had been treated previously with two other antidepressant medications for “anxiety and depression” and a history of “impatience” and “compulsiveness,” the NTSB noted.

An investigation of another plane crash, resulting in two fatalities in Kingsport, Tennessee, in August 2003, found Zoloft in the blood and liver of a private flight instructor, according to an accident report by the NTSB.

In the policy statement published in the Federal Register, the FAA seems to justify the use of these drugs via the fully debunked “chemical imbalance in the brain” theory when writing: “All these medications are SSRIs, antidepressants that help restore the balance of serotonin, a naturally occurring chemical substance found in the brain.”

“Increasingly accepted and prevalently used, these four antidepressants may be used safely in appropriate cases with proper oversight and have fewer side effects than previous generations of antidepressants,” the FAA wrote, with no citation to any scientific paper to back up this assertion.

In fact, the current labels on SSRIs warn that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

“Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence,” according to Dr Breggin.

CCHR has set up a great website with a one-of-a-kind search engine that allows the public and officials to access the database on side effects reported to the FDA on SSRIs, and every other psychiatric drug. The site also has a search engine to access all the International warnings and studies on psychiatric drugs which have been summarized so they are easy to understand, even to a lay person.

Input Only From the Choir

On April 6, 2010, Bob Fiddaman, author of the long-running popular website and blog, “Seroxat Sufferers,” sent a request to the FAA, under the Freedom of Information Act, seeking information on the change in policy.

In the Federal Register, the FAA claims it came to its decision after “careful consideration.” However, in the 58 pages of documents sent to Fiddaman on June 9, 2010 (and kindly shared with this author), there is no mention of consultations with any of the prominent SSRI experts who may have offered a contrary view. Like Peter Breggin for instance.

The FAA’s response to Fiddaman shows the agency has been discussing the policy change since at least 2008. In response to a request for “minutes of meetings where the change in the policy was on the agenda,” as well as a list of “members present and a declaration of interests of each of the members,” the FAA sent a copy of a July 18, 2008, Memorandum, with a summary from one consultants meeting. Three outside experts attended but there were no declarations of interests, or lack thereof, by anyone at the meeting.

The summary noted that the consultants “unanimously agreed that the concept of allowing certain airmen taking antidepressant medication was reasonable and safe.” But the “unanimous consensus” was that only Prozac and Zoloft “were appropriate medications due to the longevity of their use and overall safety.”

“They also felt that only these two should be considered initially, and no other medications considered at this time,” the summary reported.

In responding to the question of whether the new policy would apply to Air Traffic Controllers, the FAA said the “new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.”

In response to a request for any information “given to FAA from outside parties that relate to the FAA’S recent change in policy regarding pilots on antidepressant medication,” the FAA sent copies of documents received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army.

“In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain,” the response said. “We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.”

The documents Fiddaman received show consideration of a 2003 study of aviation accidents that found SSRIs in 61 pilot fatalities between 1990-2001, in which the psychological condition and/or the drug use was determined to be the cause, or a factor in 16 of the accidents, or 31%.

However, there was no mention of a later November 2006 study titled, “Pilot Medical History and Medications Found in Post Mortem Specimens for Aviation Accidents,” led by Dennis Canfield, from the FAA’s Civil Aerospace Medical Institute, in the “Aviation, Space, and Environmental Medicine” journal.

For this study, toxicological evaluations were performed on 4,143 pilots involved in fatal aviation accidents during the period between January 1, 1993, through December 31, 2003, to identify all pilots found positive for medications used to treat cardiovascular, psychological, or neurological conditions.

The evaluations found one-hundred dead pilots with SSRIs in their systems including forty with Prozac, twenty-six with Zoloft, twenty-one with Paxil, and thirteen with Celexa.

Less than a month after the new policy was announced, in “Aviation International News,” on May 1, 2010, Matt Thurber reported that in a review of 127 accidents in the NTSB database since 1991, containing the word “antidepressant,” only three were nonfatal.

“In 124 of those accidents, 211 people were killed,” Thurber said. “In accident after accident, antidepressants … were found in the tissues of dead pilots, and the pilots had falsified their medical certificate applications to show that they had never been treated for psychiatric problems.”

Read the rest of this article here:  http://www.scoop.co.nz/stories/HL1007/S00116.htm

Read FOIA documents here: http://fiddaman.blogspot.com/p/faa-respond-to-freedom-of-information.html

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Prescription Pill-Popping By Far a Leading Killer as Florida’s Drug Deaths Spike 20%

Thursday, July 1st, 2010

FlaglerLive.Com
July 1, 2010

Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined. Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today by the Florida Medical Examiners Commission.

That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state.

The number of people killed by prescription drugs is a significant 20 percent increase over last year’s 6,200 deaths attributed to overdoses. Much of the increase is due to a spike in oxycodone addiction. The increase in prescription-drug addiction continues a trend that began in Florida 10 years ago, when prescription drugs overtook illegal drugs as leading causes of drug-related deaths.

Alcohol is also included in the examiners’ analysis, and it leads the way of all drug-related deaths, with 4,046.

The annual report is a stark look at the effects of legalized drug addiction and over-prescription of drugs, both of which affect a far larger segment of the population than recreational or illegal narcotics.

For the first time in 2009, the commission tracked deaths by region. In Flagler County’s district, which includes St. Johns and Putnam counties, 22 deaths were attributed to oxycodone (the fourth lowest number in the state’s 23 districts), with 13 of those deaths directly attributed to the drug, and nine cited as being present among other drugs that contributed to death.

Hydrocodone claimed 16 lives in the district. Cocaine contributed to 19 deaths in the Flagler district, though only four cases were directly attributed to the drug. In 15 cases, cocaine was present in the body in conjunction with other drugs that proved lethal. Overall in Florida, cocaine-related deaths (including the majority of cases where cocaine wasn’t directly the factor but was present in the body at the time of death), have fallen from a peak of 2,179 in 2007 to 1,462 in 2009. (Again, cocaine was the direct result of death in 529 cases out of those).

Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)

Anti-psychotic drugs carry a variety of black label warnings of increased mortality in elderly patients (including a death rate almost twice as high for people taking Risperdal, for example). Those drugs, prescribed and often overprescribed in nursing homes and assisted living facilities, include Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa.

“Certainly, the actual number of prescription drug deaths is higher than the annual report states,” Kramer said. “It is unknown just how much higher because the Medical Examiners Commission does not track these classes of drugs.”

Two years ago Kramer got his concern heard by the commission following an email exchange with a commissioner in which he argued that antidepressants and anti-psychotic drugs’ contributions to mortality should be part of the annual report. He was rebuffed. One examiner vsaid he had not seen “more than the occasional death caused by these types of drugs,” according to the minutes of the Aug. 13, 2008 meeting of the commission.

Read entire article:  http://flaglerlive.com/7256/florida-prescription-drugs-deaths-oxycontin-oxycodone

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Wrongful Death Suit Claims Anti-depressant Led to Elderly Couple’s Murder-Suicide

Friday, May 28th, 2010

The West Virginia Record
By Lawrence Smith
May 28, 2010

RIPLEY — The murder-suicide of a Jackson County couple is at the center of a wrongful death, and product liability suit against New York pharmaceutical company.

Forest Laboratories and Forest Pharmaceuticals are named as co-defendants in a lawsuit filed in Jackson Circuit Court on April 30 by Robin J. Hall. In her six-count complaint, Hall, 49, a resident of Staats Mill, alleges Forest failed to alert both her father, and his physician of potentially dangerous side-effects of medication he was taking which resulted in him taking the life of his wife, then his own.

Located in New York, N.Y., Forest Laboratories is the parent company of Forest Pharmaceuticals based in St. Louis, Mo. Forest Pharmaceuticals handles the manufacture, sell and distribution of all Forest products in the United States.

In her suit, Hall says her father, Robert Raines, was prescribed Celexa by his doctor on April 24, 2008. Later that day, Raines purchased Celexa in 20 mg tablets.

Celexa is the brand name for Citalopram, a psychoactive drug in the class of selective serotonin reuptake inhibitors. It is used mostly for treatment of depression by altering a person’s serotonin levels.

Forest, Hall alleges, was aware Celexa caused an increased risk of suicidal behavior in people over 65, yet failed to conduct any further testing or investigation. Also, she alleges in its promotional materials, Forest failed to warn not only patients, but also physicians and pharmacists of that risk.

As early as Oct. 15, 2004, Forest was aware of the causality between SSRI drugs like Celexa and suicidal behavior in children. It was then, the U.S. Food and Drug Administration ordered Forest to put a “black box warning” on Celexa for anyone under the age of 24 about the potential risk of suicidal behavior.

Read entire:  http://www.wvrecord.com/news/227152-anti-depressant-led-to-elderly-couples-murder-suicide-jackson-suit-claims

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The Huffington Post: “Pilots Taking Antidepressants? The FAA Is Risking Our Lives”

Monday, April 19th, 2010

The Huffington Post
By Peter Breggin
April 19, 2010

A few years ago I was hired by the FAA to defend the agency against a suit brought by a pilot who wanted to fly while taking a prescription antidepressant. I helped the FAA formulate its defense of the agency’s ban on pilots using antidepressants and, as a result, the ban remained in effect. Pilots remained unable to fly while taking antidepressants, including the newer ones such as Prozac, Paxil, Zoloft, Celexa, Lexapro and Effexor.

How times have changed. Ignoring the scientific data on adverse drug effects that the agency and I generated and evaluated for the earlier case, the FAA is lifting its 70-year-old ban on allowing pilots to take antidepressants. Has the science changed–improving the adverse reaction profile of these drugs? To the contrary, since that time my most dire observations have been confirmed in the FDA-approved label for all antidepressants. Now there is not only a Black Box Warning for suicidality in children, youth and young adults, but also a lengthy Warnings section about a variety of extremely dangerous abnormal behavioral reactions in all ages including aggression, hostility, disinhibition, impulsivity and mania. Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence.

According to the FDA-approved guidelines, prescribers are supposed to give a special Medication Guide to patients and their families that warns about dangerous drug-induced reactions including suicide, violence and a variety of unexpected negative behaviors. Originally intended for children and youth, the Medication Guide is now expanded to cover all age groups, including adults. The Medication Guide for all ages can be found at the conclusion of each FDA-approved label for antidepressant drugs in the 2010 Physicians’ Desk Reference.

Why did the FAA lift the ban on pilots using antidepressants? According to FAA statements to the media, depressed pilots sometimes kept on flying while secretly taking antidepressants. “Our concern is that they haven’t necessarily been candid,” FAA Administrator Randy Babbitt reportedly told the press on a conference call. They were flying below the radar of drug testing, so to speak. The new policy not only allows pilots to use antidepressants, it grants a degree of amnesty to those who have been using them illegally in the past.

The FAA feels it’s safer to allow the use of antidepressants because it will make it easier for pilots to obtain needed treatment for depression. It supposedly will also make it easier to monitor their use of these dangerous drugs. If we accept this argument, why not legalize stimulants such as amphetamine as well? They would help keep the overworked pilots awake. And while the FAA is at it, why not let them use marijuana, since they may be doing it illegally on their own without anyone monitoring them.

Unfortunately, monitoring pilots on antidepressants won’t work nearly as well as might be hoped. Many severe emotional and behavioral reactions occur in the first one to three days of antidepressant dosing, or shortly after dose changes, either up or down–long before the next scheduled appointment. Although close monitoring and informing the family to be on the alert can be helpful, and should be done, it won’t prevent many of the drug reactions that occur abruptly and without warning. In addition, doctors too often fail to warn the patient and the family about the risks. As a medical expert, I’ve learned how cavalier some prescribers are in regard to warning patients about the adverse effects of any psychiatric drugs.

Read entire article:  http://www.huffingtonpost.com/dr-peter-breggin/antidepressants-pilots-ta_b_542240.html

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