August 2, 2009 • 12:22 am 2
2004-2008: 2,442 Babies with heart disease, 3,372 birth defects, 1,072 miscarriages, abortions and other deaths from psychiatric drugs
Decrypted FDA Reports Reveal 2,442 babies with heart disease, 3,372 birth defects, 1,072 miscarriages, abortions and other deaths from psychiatric drugs. Also 4,268 suicides, 2,452 other deaths, 195 homicides from psych drugs 2004-2006 alone!
Check out the decrypted MedWatch safety reports, now available to the public on reports since 2004, on CCHR’s new website (http://www.cchrint.org/psychdrugdangers/). These decrypted reports are available nowhere else as the FDA has done little or nothing with their AERS system. So please share the information with health care providers, policy makers etc.
More importantly, please share this with people who are taking or considering taking psychiatric drugs.
The report totals reveal that between 2004-2008 the FDA’s MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths. Between 1-10% of actual cases ever get reported to the FDA according to their own estimates.
Prenatal and Neonatal Exposure Drug Tables: http://www.cchrint.org/psychdrugdangers/MothersAct.html
YouTube promotional video: http://www.youtube.com/watch?v=gDdA7WPgeDM&feature=PlayList&p=B9EA75455D155D89&index=1
If you have ever made a safety report with MedWatch, you would hope that the FDA did something with that information. I personally opened the copy of my report after making it and downloading a copy of what gets sent to them from filling in the forms on their website, and found that it looked like nothing more than a bunch of garbledegook. You can see from reading this press release why that is, and how it’s no different for anyone who actually requests to see the MedWatch reports from the FDA, but actually even harder to decipher. Be sure to watch the instructional video for an explanation of how to use the tables, so that you don’t end up missing any of the information that you need in order to understand the FDA’s labeling of different things in the reports.
Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths,195 homicides from psychiatric drugs in 2004-2006 alone
For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA’s MedWatch reporting system and made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).
The report totals reveal that between 2004-2008 the FDA’s MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.
The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.
The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency’s strongest warning—short of banning a drug).
It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.
Since the reform of the(PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report to the FDA’s MedWatch system— (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years’ worth of data to make this information available.
The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA’s MedWatch system.
Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as “anecdotal” by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best “signal” event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.
For years the information contained in the FDA’s MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR’s stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full “informed consent” regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.
July 23, 2009 • 1:00 pm 3
Posted : Thursday Jul 23, 2009 11:32:42 EDT
The Senate on Wednesday ordered an independent study to determine whether an increase in military suicides could be the result of sending troops into combat while they are taking antidepressants or sleeping pills.
Sen. Benjamin Cardin, D-Md., who pushed for the study, said he does not know whether there is a link, but he believes prescription drug use, especially when it is not closely supervised by medical personnel, needs a closer look.
“One thing we should all be concerned about is that there are more and more of our soldiers who are using prescription antidepressant drugs … and we are not clear as to whether they are under appropriate medical supervision,” Cardin said.
The problem, he said, is that some antidepressants “take several weeks before they reach their full potential,” and during that time there is a risk of increased suicidal thoughts among 18- to 24-year-olds — an age group that includes many service members.
When people taking antidepressants are deployed, they may not be under close medical supervision, especially if they are in a unit that is on the move in combat, Cardin said.
“Surveys … have shown that as many as 12 percent of those who are serving in Iraq and 17 percent of those who are serving in Afghanistan are using some form of prescribed antidepressant or sleeping pills,” Cardin said. “That would equal 20,000 of our service members.”
By voice vote, the Senate approved a Cardin-sponsored amendment to the 2010 defense authorization bill that would order an independent study by the National Institute of Mental Health on the potential relationship between suicide or suicide attempts and the use of antidepressants, anti-anxiety and other behavior-modifying prescription drugs.
That study is expected to take two years. In the meantime, Cardin’s amendment also would require a report every June from 2010 through 2015 giving the number and percentages of troops who are serving or have served in Iraq or Afghanistan who had prescriptions for antidepressants or similar drugs.
The reports would not include names or any specifics that would identify the service members, Cardin said. “We protect their individual privacy,” he said. “There is no stigma attached at all to this survey.”
April 3, 2009 • 1:20 pm 0
YOUR GOVERNMENT AT WORK
Mental health screening targets moms-to-be
Questionnaire will be used to determine ‘depression’ in patients
Posted: April 02, 2009
11:50 pm Eastern
© 2009 WorldNetDaily
A bill that would subject pregnant women to mental health screenings – and possibly medications that would follow any diagnosis of “depression” – has returned and already is more than halfway through Congress, a concerned family group is warning.
WND reported a year ago when the plan was proposed to allow the government to order tests on mothers for baby blues. The proposal later died.
However, officials with United Nonprofits and Individuals for Truth and Ethics say the bill is back, and it already has been approved by the U.S. House and assigned to a Senate committee under the designation S.324.
It’s named the “Melanie Blocker Stokes Mother’s Act” after a pharmaceutical sales manager who killed herself by jumping out of a window after receiving four cocktails of antidepressants, anti-anxiety and antipsychotic drugs and electroshock therapy following the birth of her child.
UNITE leaders cite other examples of situations they say could re-occur should the bill become law.
2005: A 30-year-old Indiana mother taking anti-depressants ends up facing charges she murdered her two sons, ages 2 and 9.
2001: Andrea Yates is accused of drowning five children, ages 6 months to 7 years in the family bathtub. She had been taking anti-depressants Effexor and Remeron.
New Jersey already has implemented a plan similar to the new federal legislation, and it currently screens new moms for conditions that could be treated chemically. Lisa Bazler, a former therapist, told WND the federal plan is essentially the same as the 2008 proposal, which specified the government “shall” educate women concerning postpartum depression “before such women leave their birthing centers” as well as “screen new mothers for postpartum conditions.”
The newest plan makes some changes in the wording, ordering that officials are “encouraged” to do research on postpartum conditions and that “activities … shall include conducting and supporting” research, development of better screening and “information and education programs for health care professionals and the public.”
Bazler told WND the key is the wording that provides no informed consent for those who are being “studied” and “treated.”
“The vagueness of the language this year means that they will probably do even more than we can imagine – there is no specificity to lock them into any sort of exact program,” she warned. “They can do with it what they want.
“What is being done currently, if you look under the hood and at the legislative history of the bill and all the front groups pushing it, is a movement towards universal mental health screening – including mandatory screening of women as they do in New Jersey – and preventive drugging during pregnancy or postpartum,” she said.
UNITED has a link to a YouTube video that shows one family’s encounter with Effexor, an anti-depressant. The video also is embedded here:
“Tell them you strongly oppose the MOTHERS Act,” said Patricia Weathers and Sheila Matthews of Able Child on the website.
According to Bazler, the bill would impose “a highly subjective questionnaire” on mothers about their moods, generating diagnoses that could include depression.
“These labels almost ALWAYS lead to an antidepressant drug prescription, and antidepressants are known to cause SERIOUS SIDE EFFECTS including suicide, homicide, and infant death,” she wrote.
New Jersey’s “first-of-its-kind” law requires doctors to “educate expectant mothers and their families” about postpartum depression and to screen the mothers for the condition.
UNITE founder Amy Philo has described her own experience with Zoloft.
“I had a hallucination where I was walking past the stairs, and I was carrying my son to the bassinet,” Philo said. “I looked over and visualized a ghost of me standing on the stairs and throwing him over. That’s when I thought I was really about to snap.”
She sought a change in her prescription and ended up locked up in a hospital.
“There was no counseling or anything. I was locked up like a prisoner, and I was there from Saturday to Monday.” Finally, she quit taking her prescription completely. “That’s when I finally got better.”
September 28, 2008 • 12:26 am 12
Prescription for Violence: Is there a Connection Between School Shooters & Psychiatric Drugs?
New Documentary Exposes Rampant Pharmaceutically–Induced School Shootings
22 September 2008
The Kauhajoki Finland school shooting, which left 11 dead and 2 wounded, could be the latest in the chain of psychiatric drug induced school shootings highlighted in a new documentary entitled Psychiatry: Prescription for Violence — created by the mental health watchdog, Citizens Commission on Human Rights (CCHR). With 54 dead and 105 wounded from recent school shooters under the influence of psychiatric drugs documented to cause suicidal behavior, mania, psychosis, hallucinations, hostility and “homicidal ideation,” CCHR is calling on Finland’s law enforcement and press to fully investigate the school shooter’s psychiatric drug history. The group says this is the second major school shooting to happen in Finland in less than a year: last November, Pekka-Eric Auvinen joined the growing list of school shooters under the influence of psychiatric drugs documented by the U.S. Food and Drug Administration to cause suicidal behavior and homicidal thoughts. In other instances, the shooter’s medical records were never made public, so their psychiatric drug use remains in question. School shootings committed by individuals under the influence of psychiatric drugs include:
- DeKalb, Illinois – February 14, 2008: 27-year-old Steven Kazmierczak shot and killed five people and wounded 16 others before killing himself in a Northern Illinois University auditorium. According to his girlfriend, he had recently been taking Prozac, Xanax and Ambien. Toxicology reports showed that he still had trace amounts of Xanax in his system.
- Omaha, Nebraska – December 5, 2007: 19-year-old Robert Hawkins killed eight people and wounded five before committing suicide in an Omaha mall. Hawkins’ friend told CNN that the gunman was on antidepressants, and autopsy results confirmed he was under the influence of the “anti-anxiety” drug Valium.
- Jokela, Finland – November 7, 2007: 18-year-old Finnish gunman Pekka-Eric Auvinen had been taking antidepressants before he killed eight people and wounded a dozen more at Jokela High School in southern Finland, then committed suicide.
- Cleveland, Ohio – October 10, 2007: 14-year-old Asa Coon stormed through his school with a gun in each hand, shooting and wounding four before taking his own life. court records show Coon had been placed on the antidepressant Trazadone.
- Blacksburg, Virginia – April 16, 2007: The psychiatric drug history of Seung-Hui Cho in the Virginia Tech Massacre was never made public. Initial reports stated that “depression medication” was found among Cho’s belongings. But neither his toxicology reports, nor his recent medical history were ever released to find out whether Cho had been in withdrawal from psychiatric medication. (33 were killed and 29 injured, but this was not included in the total of dead and wounded cited above.)
- Red Lake Indian Reservation, Minnesota – March 21, 2005: 16-year-old Native American Jeff Weise, reportedly under the influence of the antidepressant Prozac, went on a shooting rampage at home and at his school, killing nine people and wounding five before committing suicide.
- Greenbush, New York – February 2004: 16-year-old Jon Romano strolled into his high school in east Greenbush and opened fire with a shotgun. Special education teacher Michael Bennett was hit in the leg. Romano had been taking “medication for depression.”
- El Cajon, California – March 22, 2001: 18-year-old Jason Hoffman was on two antidepressants, Effexor and Celexa, when he opened fire at his California high school wounding five. Hoffman had also undergone an “anger management” program.
- Williamsport, Pennsylvania – March 7, 2000: 14-year-old Elizabeth Bush was on the antidepressant Prozac when she blasted away at fellow students in Williamsport, Pennsylvania, wounding one.
- Conyers, Georgia – May 20, 1999: 15-year-old T.J. Solomon was being treated with a mix of antidepressants when he opened fire on and wounded 6 of his classmates.
- Columbine, Colorado – April 20, 1999: 18-year-old Eric Harris was on the antidepressant Luvox when he and his partner Dylan Klebold killed 12 classmates and a teacher and wounded 23 others before taking their own lives in the bloodiest school massacre in history. The coroner confirmed that the antidepressant was in his system through toxicology reports while Dylan Klebold’s autopsy was never made public. Harris and Klebold underwent “anger management” and “death education” classes.
- Notus, Idaho – April 16, 1999: 15-year-old Shawn Cooper fired two shotgun rounds in his school narrowly missing students; he was taking a mix of antidepressants.
- Springfield, Oregon – May 21, 1998: 15-year-old Kip Kinkel murdered his own parents and then proceeded to school where he opened fire on students in the cafeteria, killing two and wounding 22. Kinkel had been on Prozac. Kinkel also underwent “anger management” classes.
This message is a public service announcement provided by the Citizens Commission on Human Rights International. For more information, contact CCHR at 800-869-2247 or email firstname.lastname@example.org
December 16, 2006 • 5:53 am 1
Breggin says it best, so for now my comments are unnecessary.
The Big Suicide Loophole in Antidepressant Drug Safety Studies
Peter R. Breggin, M.D.
On December 13, 2006 the FDA’s Psychopharmaceutical Drugs Advisory Committee (PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.
Now the agency has given advanced notice of its new findings—antidepressants, all of them according to the FDA, cause increased suicidality in young adults. Suicide occurs more than twice as much on antidepressants than on sugar pills in individuals under age 25.
First the agency admits that antidepressants cause suicidality in children. Now the agency admits the drugs cause the same disasters in young adults. Meanwhile, an independent review of all antidepressant trials submitted to the FDA has shown that the drugs are no better than placebo.[i] America’s drug watchdog needs to come clean. It’s been approving depressants as antidepressants.
The Largest Loop Hole
But it gets worse. The primary data on suicidality has been generated in short-term controlled clinical trials planned by drug companies, carried out by drug company hacks, and evaluated by drug company employees at corporate headquarters. If that kind of carefully cultivated evaluation bears such bad fruit, imagine what the real data must show.
Since I first began working as a medical expert in product liability cases way back in the early 1990s, I’ve spent innumerable hours culling the sealed data contained within the files of companies like GlaxoSmithKline and Eli Lilly. Among other things, I long ago found evidence that Paxil and Prozac cause suicidality in adults. These discoveries then led to settlements in product liability suits brought against the two companies brought by surviving family members. I’ve also communicated my conclusions in books like Talking Back to Prozac and the Antidepressant Fact Book and in scientific articles but the primary data until recently remained sealed.
Drug company groomed data creates the biggest loophole in the FDA’s evaluations of drug safety. In May 2006 GSK published a Dear Healthcare Provider letter admitting that Paxil causes suicidality in depressed adults, but even that data was diluted before it was processed. The real picture is even worse.
Paxil Suicide Data Sealed in Company Files
I recently published analyses of previously sealed GSK data on Paxil suicide in the peer-reviewed journal Ethical Human Psychology and Psychiatry. I combed the data out of GSK files during a several-day investigation of the company’s Paxil records. My original medical-legal report recently became unsealed and provided the basis for the published reports.
The first report shows how GSK omitted some suicides and suicide attempts from their tables and from the data sent to the FDA.[ii] The second shows how the company hid data on Paxil-induced akathisia (psychomotor restlessness) and its relationship to suicidality.[iii] The third shows how the company hid the basic concept of activation or stimulation that recently became a central part of the newly mandated antidepressant labels.[iv] [Go to Breggin Selected Scientific Papers for Paxil Special Reports 1 through 3]
Prozac Suicide Data Sealed in Company Files
The sealed Prozac data from Eli Lilly also came from my investigations of the company as a medical expert in product liability suits. BMJ (The British Medical Journal) recently obtained the sealed documents from an anonymous source and released them to the FDA and the U.S. Congress. The documents are contained in four Lilly PDFs that can be downloaded from my professional website [http://www.breggin.com/].v]
Lilly PDFs 1 to 3 show that the drug company knew in 1985 that patients taking Prozac had a 12 to1 increase in suicide attempts compared to placebo or to an older antidepressant. This original data and the analyses were never shown to the FDA until the BMJ recently forwarded them to the agency. The FDA has never responded. [Go to Lilly PDF 1] [Go to Lilly PDF 2] [Go to Lilly PDF 3]
Lilly PDF 4 contains several studies. Most important, two in-house memoranda show that Eli Lilly was purposely hiding suicide attempts and suicide ideation by coding them under false categories, such as “depression” and “no drug effect” (pages 3 and 4 of Lilly PDF 4). Eli Lilly employee Claude Bouchy expressed shame about going along with this fraudulent practice: “I do not think I could explain to the BGA [the German regulatory agency], to a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicide ideation.” [Go to Lilly PDF 4] The data used to evaluate antidepressant-induced suicidality in adults is not reliable. This is a fact the FDA has yet to face. The data has been pruned, culled and manipulated by the drug companies before being tabulated and released. The FDA must send investigators into the original drug company files to search and analyze the primary sources of data, much as I have done as a medical expert in product liability suits against drug companies. I will be happy to share my knowledge with FDA officials on how to conduct these searches and analyses.
[i] Kirsch, I. and Sapirstein, G. (1998). Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention & Treatment, 1, Article 0002a, 16 pages, posted June 26, 1998. http://www.journals.apa.org.
[ii] Breggin, P. (2006a). Court filing makes public my previously suppressed analysis of Paxil’s effects. Ethical Human Psychology and Psychiatry, 8, 77-84, 2006. Available on http://www.breggin.com.
[iii] Breggin, P. (2006b). How GlaxoSmithKline suppressed data on Paxil-induced akathisia: Implications for suicide and violence. Ethical Human Psychology and Psychiatry, 8, 91-100.
[iv] Breggin, P. (2006c) Drug company suppressed data on paroxetine-induced stimulation: Implications for violence and suicide. Ethical Human Psychology and Psychiatry, 8, 255-263.
[v] Lilly Documents, Folders 1-4 (2006). Dr. Breggin analyzes Eli Lilly Prozac-induced suicide and violence documents now in possession of the British Medical Journal (BMJ). http://www.breggin.com/. Retrieved December 10, 2006.
Go to Scientific Papers of Peter R. Breggin, MD
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