Seroquel's blood sugar, weight gain, and heart side effects are well-known. AstraZeneca, maker of Seroquel, engaged in deceptive and misleading practices when it marketed Seroquel for unauthorized, or "off-label," uses and failed to adequately disclose the drug's serious potential side effects to health care providers, including hyperglycemia and diabetes mellitus. Its 2009 approval as a drug for depression helped it reach sales of $5.3 billion, and it was also approved for schizophrenia and bipolar disorder. FDA regulators opposed its use as a first-choice, stand-alone treatment for the 10 percent of the U.S. population with depression when safer treatments exist.
The Illinois state Attorney General's office has reached a $3.1 million settlement with the major pharmaceutical company AstraZeneca following allegations that it improperly marketed and promoted Seroquel. The agreement is part of a record 37-state settlement totaling $68.5 million, the largest ever multi-state consumer protection settlement against pharmaceutical companies. These practices violate Informed Consent requirements set forth by federal law to protect patients and ensure that health care providers are fully informed about the medications they prescribe, including all known potential benefits and side effects. AstraZeneca has already settled nearly 25,000 personal-injury lawsuits pertaining to Seroquel, with more to come, says ABC News.
Prozac (Fluoxetine HCL)
Eli Lilly's Prozac was the first SSRI on the market in 1988. According to Lilly's Prozac website, Prozac has been prescribed for more than 40 million people worldwide. In recent years, Prozac has also become available in its generic form, Fluoxetine HCL.
The question of whether or not Prozac can cause some people to become homicidal or suicidal goes back many years. In February 1990, two prominent Harvard researchers and psychiatrists, Dr. Martin Teicher and Dr. Jonathan Cole published an article in the American Journal of Psychiatry entitled: Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment. The article reported that "persistent, obsessive, and violent suicidal thoughts emerged in a small minority of patients treated with fluoxetine." Since that time, many other researchers have published articles with similar findings. However, those articles have been largely ignored by the popular media and dismissed by the pharmaceutical industry and the FDA.
In the meantime, various lawyers have amassed considerable damning evidence from the internal, unpublished files of Eli Lilly.
Although no civil wrongful death case has yet been won, Lilly has lost many battles on the issue of whether there is legally admissible, scientifically reliable evidence linking Prozac to suicide and other violent behavior.
Most of the civil cases involving Prozac have been settled out of court. However, in the two cases which have gone to trial, Lilly has achieved "apparent" wins. The first was a 1994 case in Kentucky state court. Lilly got a 9:3 verdict in its favor and then publicized this verdict as a "vindication" of Prozac. It was later found that Lilly had quietly settled the case for an undisclosed sum before the verdict was returned.
On March 22, 2004, the question "Can Prozac cause suicide in some people?" was finally answered. Prozac was named in the FDA Public Health Advisory warning of a link between antidepressants and suicide. The advisory states, "health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases."
Paxil (Paroxetine HCl)
"Can Paxil cause some people to become homicidal and/or suicidal?" This was the first question posed to the jury in the case of Tobin v. SmithKline Beecham. Their June 6, 2001, verdict answered with a resounding "yes" and an $8 million damage assessment.
Paxil, which was released onto the American market in 1992, was the third of the SSRI's on the market in the US. Paxil is FDA approved for the treatment of depression and certain anxiety disorders. Paxil and the new Paxil CR (controlled release) generate over two billion dollars per year for GlaxoSmithKline making it one of the company's biggest sellers.
On March 22, 2004, Paxil was included in the FDA Public Health Advisory finally acknowledging the link between antidepressants and suicide. The advisory states "health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases."
For the first time, a jury found a pharmaceutical firm liable for the death of a patient taking an antidepressant. A federal jury in Cheyenne, Wyoming, ordered SmithKline Beecham (now GlaxoSmithKline) to pay $6.4 million to relatives of Donald Schell. Schell, age 60, had been taking Paxil for just 48 hours when he shot and killed his wife, his daughter, his granddaughter and himself. The verdict may alter the landscape in a class action suit that has floundered in the courts.
Although plaintiffs' lawyers had filed hundreds of cases against the manufacturers of the three leading antidepressants, all but three of those suits were dismissed or settled. The first two cases to reach trial, both against the makers of Prozac, ended in verdicts for the manufacturer. But now, with the dramatic victory in the Paxil case, plaintiffs' lawyers say the drug companies will be more willing to settle and will face a tougher future when they take cases to court. According to Andy Vickery, who tried the case for the plaintiffs, the verdict lays firm groundwork for future cases involving Paxil because the Wyoming jury found the medication could cause someone to commit suicide or homicide. He also believes the verdict is bad news for makers of the other two antidepressants which will be implicated by association.
Zoloft is an antidepressant that has has been linked to suicidal behavior in some users. Zoloft is used to treat depression, panic disorder, social anxiety disorder, obsessive compulsive disorder, premenstrual dysphoric disorder, and post-traumatic stress disorder in adults, children and adolescents. It is manufactured by the drug maker Pfizer.
In December of 2001, Flora Motus of California sued Pfizer for selling a drug that drove her husband Victor Motus to suicide. In 1998, Victor Motus was scheduled to fly to Washington DC to receive an award from President Clinton for his work in a local school district, when instead, he killed himself. He had stated on multiple occasions previously that the Zoloft he was using was making him "crazy." Motus's lawyers argued that Pfizer should include a warning that Zoloft could cause suicide thoughts in some people.
Pfizer's legal team was aware of Tobin v. SmithKline trial and fearing that their case might face the same outcome sought help from Daniel E. Troy, Chief Legal Counsel of the US Food and Drug Administration. Immediately prior to his appointment of Chief Legal Counsel, he had been a Pfizer lawyer and long-time champion of the drug companies, working against the federal agency he now worked for.
The Pfizer legal team asked Troy to file a brief saying that the FDA agreed with Pfizer's contention that SSRIs do not increase the likelihood of suicidal behavior. Troy completely ignored the current findings and filed a brief that stated that the FDA had dismissed the idea that SSRI antidepressants increase some people's risk of suicide. When later asked about the recently concluded Tobin case, Troy claimed that he was unfamiliar with it.
Developed by the Danish pharmaceutical company Lundbeck, Escitalopram was introduced to the U.S. market under the name Lexapro and distributed by the American pharmaceutical company Forest in 2002. The antidepressant Lexapro is used to treat major depression, some associated with mood disorders.
Since its introduction, Lexapro has come under close scrutiny for its connection to suicide in children, adolescents, and adults. Lexapro and Celexa have been included in the recent FDA Public Health Advisories on antidepressants and suicide. The FDA has required the manufacturer, Forest Laboratories, to include a Black Box warning about the increased risk of suicide in children and adolescents taking Lexapro or Celexa.
Celexa (Citalopram HBr) and Lexapro (Escitalopram Oxalate) are members of the class of drugs known as SSRIs (Selective Serotonin Reuptake Inhibitors) which also include Prozac, Paxil and Zoloft. Forest Pharmaceuticals received FDA approval for Celexa in 1998. Celexa was touted as having fewer side effects than earlier SSRI drugs.
Effexor (Venlafaxine HCL)
Effexor (Venlafaxine HCL) was introduced in 1993 by Wyeth Pharmaceuticals. It belongs to a class of drugs called SNRI. Wyeth's Effexor XR website states, "Effexor XR is thought to work on both serotonin and norepinephrine - two chemicals in the brain linked to depression. Correcting the imbalance of these two chemicals may help relieve symptoms of depression
In August of 2003, Wyeth warned physicians about about the link between Effexor and increased incidence of hostility and suicide-related events, such as suicidal thoughts and self-harm. Doctors were warned to be alert to signs of suicidal ideation in children and adolescents using Effexor or Effexor XR and to reassess the benefit-risk ratio when treating individual patients.
Since that time, the FDA has acknowledged the link between Effexor and suicide issuing several public health advisories and requiring Wyeth to put a Black Box Warning on Effexor. An FDA public health advisory stated:
"Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased."
Cymbalta (Duloxetine HCl), manufactured by Eli Lilly, was approved by the FDA and approved for sale in August of 2004. Labeling for Cymbalta warns about the increased risk of suicide.
Traci Johnson, a 19-year-old woman, with no previous depressive symptoms, was participating in a clinical trial for Cymbalta when she committed suicide on the 7th of February 2004, by hanging herself in the Lilly Laboratory for Clinical Research. In previous trials of Cymbalta, there were four other individuals who had committed suicide, and eleven had attempted suicide. Traci Johnson had joined the trial only a few weeks earlier, in January.
You are entitled to Informed Consent, under the Patient's Bill of Rights, a bill first adopted by the American Hospital Association in 1973. The bill states that you have the right to considerate and respectful care, and you are encouraged to obtain from physicians and other direct caregivers relevant, current, and understandable information concerning diagnosis, treatment, and prognosis. In keeping with these practices, I have informed you of the Top 7 Dangerous Psychiatric Drugs, and I strongly recommend that you thoroughly investigate any drug prescribed to you by any doctor, especially psychiatrists. To protect yourself, investigate any drugs recommended or prescribed to you on reputable websites not related to pharmaceutical companies, and go BlackBoxRX.com for an extensive list of all medications with Black Box warnings. Be an informed consumer, not a guinea pig. Be healthy, be happy, and take care of yourself.
Michael Locklear is a researcher and consultant with 30 years experience, studying health, nutrition, and human behavior. He has been president of the Global Peace Project since 1986, and he administrates the website www.Natural-Remedies-for-Total-Health.com as part of the Global Peace Project Educational Outreach Program. You can also find him on The Total Health Blog.
Published by Michael Locklear
Michael Locklear is a researcher and consultant with 30 years experience, studying health, nutrition, and human behavior. He has been president of the Global Peace Project since 1986. View profile
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