The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.

Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.

Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.

The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.

As AstraZeneca prepares to report its second-quarter earnings at the end of this month, it faces additional scrutiny this week. The F.D.A. is considering the London-based company’s dapagliflozin, a proposed diabetes drug with Bristol-Myers Squibb, and is expected to decide soon on Brilinta, an anticoagulant. The company is facing the loss of patents for Seroquel next year and for the heartburn drug Nexium in 2014.

Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.

The previous Seroquel labels had mentioned the risk of a prolonged QT interval, but had not identified other drugs to avoid, Stephanie Andrzejewski, a spokeswoman for AstraZeneca, said Monday. The new warning also is separated from other warnings and precautions on the label, she said, “to provide some additional guidance to physicians” treating patients ”who are already at risk of QT prolongation.”

The new warning will be added to printed labels as soon as possible, Ms. Andrzejewski said.

The new label lists the other drugs to avoid as antiarrhythmic drugs like quinidine, procainamide, amiodarone and sotalel; antipsychotic drugs like ziprasidone, chlorpromazine and thioridazine; antibiotics like gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids like levomethadyl acetate and methadone. The label also raises caution about use by the aged and people with heart disease.

James J. Pepper, a lawyer in Pennsylvania who is involved in drug litigation, has been arguing for months in letters to government officials that Seroquel has a potentially deadly interaction with methadone in regard to the QT interval.

“This is a huge, huge step,” Mr. Pepper said of the label change, though he said he thought it should be stronger.

Ms. Walsh said the F.D.A. action was unrelated to Mr. Pepper’s arguments.

Three months ago, Dr. Janet Woodcock, director of the F.D.A. Center for Drug Evaluation and Research, rejected those arguments in a letter to the Project on Government Oversight, a nonprofit group in Washington, which had also raised the issues. Dr. Woodcock wrote that a thorough agency review had found it “exceedingly unlikely” that patients faced an unreasonable risk from the interaction between Seroquel and methadone. The review found only one death that was probably caused by the interaction, she wrote.

Dr. Woodcock concluded that the F.D.A. would take no action to change the label. Ms. Walsh said that conclusion was still correct, because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.

Methadone use and deaths have increased drastically in recent years as more doctors prescribe it for chronic pain. The number of methadone prescriptions for pain in the United States rose to 4.3 million in 2010 from 2.2 million in 2006, IMS Health, an industry data firm, said Monday. The use for pain has surpassed that for heroin withdrawal and maintenance.

URL: http://www.nytimes.com/2011/07/19/health/19drug.html?_r=1

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Misconduct charges include accepting kidney from patient

The New York State Health Department has revoked the license of an Elmira psychiatrist who has admitted charges of misconduct including accepting a kidney from a patient.

Dr. Carlos Delos-Reyes received his license to practice medicine in New York in March 1987. His license will be permanently restricted, effective June 21, and he will be prohibited from practicing in New York State.

According to a statement of charges issued by the state Board for Professional Medical Conduct, Delos-Reyes provided psychiatric care to patients at St. Joseph’s Hospital in Elmira, Family Services of Chemung County Mental Health Clinic or at the patients’ homes.

The misconduct charges filed against him include gross negligence, moral unfitness, willfully making a false report and failure to maintain adequate records for each patient.

» Between January 2010 and October 2010, Delos-Reyes failed to document a patient’s psychiatric, drug and alcohol use histories, and didn’t notice the patient’s adverse reaction to lithium, a mood stabilizing drug that Delos-Reyes prescribed without first evaluating the patient’s baseline kidney and thyroid function. Delos-Reyes was also charged with prescribing Xanax, used to treat anxiety attacks, without documenting the prescription. He also transcribed a prescription for Wellbutrin, an antidepressant, in the patient’s medical records but didn’t actually prescribe the medication.

» Between December 2008 and October 2009, Delos-Reyes failed to coordinate his treatment of a patient with her therapist, did not appropriately follow up on the patient’s levels of Valproic acid, a mood stabilizer used to treat conditions such as epilepsy, and did not refer the patient for metabolic lab studies.

» Between November 2005 and April 2009, Delos-Reyes accepted a kidney from a patient while serving as the patient’s psychiatrist. He also prescribed several medications for the patient without adequate medical justification, failed to document the prescriptions, and, in one instance, allowed the patient to write his own prescription. He was also charged with keeping inadequate medical records for the patient.

» From August 2005 to April 2008, Delos-Reyes failed to consult a patient’s primary care physician before treating the patient for hypersomnia, a disorder characterized by excessive amounts of sleepiness, failing to maintain an appropriate medication list for the patient and allowing the patient to complete the physician’s section of his behavioral health intake evaluation.

» From January 2004 to February 2009, Delos-Reyes did not perform an adequate psychiatric evaluation of a patient and failed to refer the patient for lab work to monitor his blood glucose and triglyceride levels.

URL:  http://www.stargazette.com/article/20110616/NEWS01/106160393/Elmira-psychiatrist-lose-license

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I would like to address the subject of medicating students at the school’s “request” or demand is more like it. This is our family’s experience.

My 12-year-old grandson is ADHD and does have some social and some behavioral issues. We are well aware of his issues and do not try to dismiss them. The school has tried to insist that he be medicated. His mother has refused to medicate him because of the damage from the ADHD drugs to his older brother. This has been explained many, many times to the school personnel.

The side effects of the drugs, Concerta, Strattera, Ritalin and Seroquel vary and the intensity varies from person to person. My older grandson who has taken these various drugs has had severe reactions to them. Some of his reactions are delusions, paranoia, the need for higher doses consistently, mood swings, and when the doses were changed to higher levels, uncontrollable anger. My daughter’s refusal to medicate the younger son stems from the reactions of her older son to the drugs.

When the school was told no, they constantly asked the child if his mother had taken him to the doctor and told him he needs to be medicated. It is very sad that a child comes home and tells his parent that he needs to be medicated. In response to her refusal and the arguments that ensued over the issue, the school has exacted what in my opinion is revenge on the child for his mother’s decision to do what she believes is best for him in the long run.

They put in place a discipline plan that my daughter did not approve of or sign but it didn’t matter. I understand that some of detentions were deserved but I disagree with the nitpicking. Examples and these are just a few: Forgetting a pencil, being early to class, being put in detention for not spitting out gum when in fact the child had and the proof was in the trash can, telling another person that they don’t want him around and he can hear it. The detentions for these silly nitpicking items added up and have created a real problem on the child’s record.

The real topper for me is the fact that they allowed him to sign up for an overnight camping trip and then decided my grandson could not go because of his record and missing assignments. How strange when we checked online to see if there are any missing assignments, they show as completed.

There are many more details to this situation. The bottom line is that they have humiliated, belittled him openly and made this child feel very unwanted. No child reacts well to this type of treatment, no child deserves this. I believe that the school lacks education in some of these disorders and needs some training. If trained properly they would be able to identify that the social, behavioral issues and learning disabilities are a part of the complex disorder and there are better ways to handle the problems.

I would be curious to know how many children are medicated and how many times the school recommends the medication because it makes the staff’s life easier. They have no concept of the long-term effects of the drugs. They are not doctors. I would also be interested in knowing how many others had experiences like this.

I am sure that this will evoke a response again blaming all of the poor behavior on the child, but I think that the professionals should take a deep look at themselves and evaluate why they behave as they have.

Diana Strohm
Muskegon

URL: http://www.mlive.com/opinion/muskegon/index.ssf/2011/06/letters_should_a_school_insist.html

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When Judge Robert Heinrichs renders sentence on August 4, will your portfolio be the one to take the fall?

On that date, it is expected that the judge will make his rulings on sentencing for a teenage boy, arrested after allegedly killing a fellow teenager in what one doctor calls a clear case of “Prozac reaction.”

“There is no reason other than a Prozac reaction,” said Dr. Peter Breggin, a New York state-based psychiatrist and author of the book, Talking Back to Prozac. “(The killing) is a mystery without that.”

The entire affair starts with, of all things, an accidental dent put in the wood floor of the home of the accused by the victim. The accused, who was not home at the time of the accident, later invited the boys back to his house to hang out. When they were hanging out, the accused pulled out a knife and stabbed the boy in the chest.

The accused had been treated for depression and was prescribed Prozac three months prior to the killing. Some studies link the drug Prozac, first patented by Eli Lilly (NYSE: LLY) with behavioral and emotional changes in users under 18 years of age, including an increased risk of suicide.

After days after he began taking Prozac, the accused attempted suicide with some medication of his grandfather’s. His parents complained to the physician that, rather than help, the drug was making the boy’s condition worse. Rather than switch to a different drug, doctors increased the dosage of Prozac.

“It was a prescription for violence,” Breggin wrote in a report for the defense.

“Within a reasonable degree of medical certainty, I believe that Prozac drove (the accused) into a state of severe agitation with manic-like symptoms including mood swings, confusion, irrationality, extreme irritability, hostility and violence.”

Breggin said the teen should have stopped taking Prozac immediately after he attempted suicide.

“Right then and there should have been the end of the Prozac,” Breggin said. “When you have a drug that is causing mania, you stop taking the drug.”

Now, one boy is dead and another is in the morgue. Will Eli Lilly’s stock take a tumble after the verdict, or will the judge find the boy’s Prozac defense is nonsense? Will other lawsuits emerge? It could be a rough season of discontent for Eli Lilly.

Read more: http://www.benzinga.com/news/global/11/06/1142243/will-prozac-murder-trial-doom-eli-lilly-stock

Related stories:  Did Prozac Cause Teenager to Kill? Psychiatrist Says Yes

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The 17-year-old teen, who was not named in the media, stabbed a 15-year-old friend after the other teen caused damage to a hardwood floor in his friend’s home. The disproportionately angry response, explains Dr. Peter Breggin, is a not-unknown side effect of the antidepressant Prozac. Dr. Breggin stated:

“There is no reason other than a Prozac reaction,” said Dr. Peter Breggin, a New York state-based psychiatrist and author of the book, Talking Back to Prozac. “(The killing) is a mystery without that.”

Nine days after starting therapy with the drug, the teen attempted suicide via an overdose of his grandfather’s pills. His parents reported the incident to doctors, who increased the Prozac dosage for the teen. Dr. Breggin says:

“It was a prescription for violence,” Breggin wrote in a report commissioned by the defence. “Within a reasonable degree of medical certainty, I believe that Prozac drove (the accused) into a state of severe agitation with manic-like symptoms including mood swings, confusion, irrationality, extreme irritability, hostility and violence.”

Prosecutors contend that the killing was a “conscious decision” made by the teenager, and that he should be accountable for the act of violence. In previous studies, Prozac has been linked to “emotional changes” and increased suicide risk in teens.

URL: http://www.inquisitr.com/111789/did-prozac-cause-teenager-to-kill-psychiatrist-says-yes/

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Admits to prescribing drugs online without seeing patients

St. John’s psychiatrist Dr. Mohamed Mekawy fought back tears Thursday at a medical board disciplinary tribunal hearing while apologizing to his family, patients and colleagues for causing them shame.

Mekawy, who admitted to prescribing medications online to patients in the United States without seeing or assessing them, was given a four-month suspension, dating back to March 7 when his licence was suspended by the College of Physicians and Surgeons of Newfoundland and Labrador (CPSNL).

He’s also been ordered to complete a prescribing course, sign a written undertaking that he will not prescribe medications via the Internet and pay a portion of the costs for Thursday’s hearing, in an agreed amount of $10,000.

These sanctions, which were proposed in a joint legal submission by his lawyer Peter Browne and the college’s lawyer Lewis Andrews, were accepted Thursday afternoon by the disciplinary tribunal.

The full decision will also be published by the CPSNL.

After the tribunal’s decision, Browne asked if Mekawy could make a statement. The doctor said he was “ethically blinded” by assurances he was given by an Internet drug company that he could prescribe to patients in this manner.

Mekawy had his medical licences suspended in Indiana, Michigan and South Carolina in 2007, but failed to report that to the Newfoundland board and falsely answered no to questions regarding any suspensions, reprimands, restrictions or disciplinary actions in other jurisdictions in a 2008 application for licence renewal in this province.

In a letter of response to the Newfoundland board in 2010, after it discovered he provided false answers on the applications, Mekawy said his “profound sense of shame” affected his judgment to the point that he chose not to mention the incident with the U.S. medical authorities.

He told the tribunal Thursday he takes full responsibility for his actions, has learned some serious lessons and promises to never engage in such unethical practices again.

The tribunal, chaired by Dr. Jody Woolfrey, with members Dr. Ed Collins and John Whalen, heard that Mekawy began practising medicine in Newfoundland in 2003. He also held licences in the U.S. states of Indiana, Michigan and South Carolina.

The Newfoundland medical board received information from the Federation of State Medical Boards of the United States in August 2010, providing a summary of reported actions regarding Mekawy’s medical licences in Indiana, Michigan and South Carolina. His licence was temporarily suspended in Indiana in late 2007, after which he voluntarily withdrew his Indiana licence prior to or in lieu of an inquiry and agreed to never again apply for a licence in that state.

Mekawy’s licences in the two other states were subsequently suspended.

Mekawy explained in his letter to the Newfoundland board, he received correspondence in 2007 from a company expressing interest in having him provide prescribing services to its Internet pharmacy, USACHOICEMEDS.com.

He said he spoke to a man by phone who said the company provided assistance to people in the U.S. who had difficulty obtaining health insurance.

Mekawy agreed to issue prescriptions for a fee and said he provided this service for about two months in July and August, 2007.

“The general protocol I followed involved the receipt of a completed questionnaire by a patient on my home computer which contained pertinent medical information along with a request for medication. I would review this information and either agree or disagree with the request,” Mekawy said.

He also said he didn’t knowingly prescribe controlled medications because he was not aware that one drug he prescribed, Soma, was considered a controlled drug in some U.S. states.

After the Indiana medical board informed him his licence was being suspended, Mekawy said the Internet drug company provided him with no support or assistance.

He said his licences in Michigan and South Carolina were also suspended, “likely due to a reciprocity agreement with the Indiana Medical Board,” but Mekawy said he didn’t use his licence in either of these two states when issuing prescriptions for the online company.

Documents filed with the Medical Licensing Board of Indiana say the investigation into Mekawy began when the Office of the Attorney General initially contacted an investigator with the Arkansas State Police who interviewed people who had obtained prescription drugs over the Internet.

In one case, a wife admitted she used her husband’s credit card to obtain the drug Soma from the online Internet pharmacy to feed her drug addiction. She admitted she never saw the doctor prior to receiving the medication. Another patient obtained Soma with his personal credit card without ever seeing Mekawy.

Indiana documents also note that Mekawy is under investigation by the Medical Board of California after an individual that he prescribed Soma to was hospitalized after overdosing on this medication.

Other drugs he was reported to have prescribed included pain medications, sleep aids and drugs to treat sexual dysfunction. Tramadol, Butalbital, Viagra, Rozerem, Ultracet, Cialis and Levitra are cited in one of the documents.

The Indiana board concluded that Mekawy’s actions represented a clear and immediate danger to public health and safety.

His lawyer, Peter Browne, expects Mekawy’s Newfoundland licence to be reinstated in July. He said he has enrolled in a two-day prescribing course in Ontario in September.

Brown also presented to the tribunal two letters of support from Eastern Health managers, Dr. Kevin Hogan, a former clinical chief of mental health and addictions and Dr. David Atwood, the current clinical chief.

Atwood said Mekawy’s online prescribing didn’t “creep” into his psychiatry practice and he had no issues with his competency. In fact, Atwood said his prescribing of psychopharmacology drugs was on a “more conservative range.”

Praising his clinical skills, Atwood said Mekawy has “strong character and reliability” and he has high personal and professional regard for him. He said if Mekawy’s licence is reinstated, he would have no problem returning him to his position at Eastern Health.

dss@thetelegram.com

URL: http://www.thetelegram.com/News/Local/2011-05-13/article-2503165/Psychiatrist-gets-fourmonth-suspension/1

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Richard Lemus interviewed the atrocious Psychiatrist, Dr. Scott Segal the owner of the Segal Institute for Clinical Research and has said:

Dr. Scott Segal, Psychiatrist, Segal Institute for Clinical Research: “It’s definitely making adults depressed, and therefore the children depressed, as well. However, they have less money to spend on treatments, and these days insurance companies have higher co-payments and it’s very difficult for people to come in.”

Even scarier, it’s hard for patients or their families to pay for the medications they so desperately need.

Dr. Scott Segal: “They get their visits and their evaluations and whatever is needed in the study for free, as well as medications. In fact, in research studies, the treatment is above the normal level of care.”

Patients will often try out new drugs that aren’t on the market yet and many times they can stay on that medication after the study is over.

Dr. Scott Segal: “In many studies, after the study is over, the pharmaceutical company will give them a compassionate care and allow them take the medications for a period of time.”

David is on a new medication and sees a doctor weekly. He and his mom have high hopes for the future.

What Richard Lemus and the Channel 7 News Fox WSVN-TV fail to revel to the public is that theirs other ways to defeat depression without the usage of the dangerous drugs. It’s called proper diet, exercise and proper outdoor activities like going to the beach or going to a park. In the whole segment of the story reported by Richard Lemus nowhere did it mention natural ways to deal with depression.

Transcript from this story can be seen on: URL: http://www.wsvn.com/features/articles/medicalreports/MI131332

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[youtube]http://www.youtube.com/watch?v=0VqP0Knb5fU[/youtube]

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Obviously you can’t go in there cursing like a sailer and demanding to get released because it will not happen.

I was reading an article that I’m about to show to you below. This Psychiatrist named Thomas M. Peterson was accused of improperly prescribing medication to his 2 children patients. The medications that he was improperly prescribing were anti-psychotics. Go to my The Dangers of taking antipsychotics article to find out how dangerous Anti-Psychotics are. I can only speculate that the Anti-Psychotics that Tomas M. Peterson was giving these children were the prescription medication Risperdal, a now approved medication by the FDA to give to children.

He had his medical license taken away and now the state board of medical examiners are reinstating his medical license for some obvious reason.

Bismarck, N. D. (AP) The state Board of Medical Examiners has reinstated the medical license of a Grand Forks psychiatrist accused of improperly prescribing medication to children.

Thomas M. Peterson’s license was reinstated on Wednesday. The board had restricted his license last month after he improperly prescribed anti-psychotic medication to two children.

The board says Peterson has since completed a course at Harvard on child and adolescent pharmacology. His license will remain on probation for three years.

The medical board also placed Lois Freisleben-Cook on probation for three years for improperly prescribing medication. The board ordered the Williston doctor to complete courses in pharmacology, ethics and record-keeping.

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[googlevideo]http://video.google.com/videoplay?docid=-3609599239524875493[/googlevideo]

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In the absence of any objective medical tests to determine who has ADD or ADHD, doctors rely in part on standardized assessments and the impressions of teachers and guardians while the they administer leave little room for other causes or aggravating factors, such as diet, or environment. Hence, diagnosing a child or adolescent with ADD or ADHD is often the outcome, although no organic basis for either disease has yet to be clinically proven. Psychiatrists may then prescribe psychotropic drugs for the children without first without making it clear to parents that these medications can have severe side-effects including insomnia, loss of appetite, headaches, psychotic symptoms and even potentially fatal adverse reactions, such as cardiac arrhythmia. And yet, despite these dangers, many school systems actually work with government agencies to force parents to drug their children, threatening those who refuse with the prospect of having their children taken from the home unless they cooperate.

End drugging our children with psychotropic drugs.

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