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

a

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

a

KERANA TODOROV | Posted: Thursday, May 5, 2011 6:15 pm

A bill designed to make it easier to involuntarily medicate Napa State Hospital patients deemed incompetent to stand trial received the green light from a state Assembly committee this week.

The measure is one of several introduced in the state Legislature this year to improve safety at the five state psychiatric facilities where violence remains a top concern.

Assembly Bill 366, co-authored by Assemblyman Michael Allen, D-Santa Rosa, allows a committee at each state hospital to authorize the involuntary medication of patients who refuse to take antipsychotic drugs for up to 21 days while the courts review their case.

The bill also requires judges to rule if patients lack the “capacity” to make decisions on whether or not to take antipsychotic drugs.

Currently, patients who are sent to state hospitals because they are deemed incompetent to stand trial and who refuse to be medicated may go without antipsychotic drugs for months while their case is reviewed by the courts, said Dr. Patricia Tyler, a psychiatrist at Napa State and a member of the Union of American Physicians and Dentists, the doctors union that strongly supports AB 366.

Patients may decide to refuse medications because they don’t believe they have a mental illness, Tyler said.

A quarter of patients who are incompetent to stand trial arrive at the hospital without a court order allowing involuntary medication, Tyler said, citing figures from the state Department of Mental Health.

This state agency oversees California’s five state psychiatric hospitals, including Napa State, where the lack of staff and patient safety has made national headlines with a patient accused of strangling psychiatric technician Donna Gross in late October.

“This is about creating a safer environment for patients and staff, one that they both expect and deserve,” Allen said this week. “To do that we must make changes to the security infrastructure of the various facilities and provide the necessary tools for effective medical treatment,” he said.

The bill, Allen said, improves the current involuntary medication process by eliminating gaps for patients who are incompetent to stand trial and committed to a state hospital.

Under the bill, judges determine at the initial trial if the patients have the capacity to make decisions regarding antipsychotic medications. The requirement, Allen told a committee earlier this week, eliminates unnecessary and redundant court hearings.

The bill received unanimous support Tuesday from the state Assembly Committee on Public Safety. Allen’s chief of staff, Sean MacNeil, expects the bill to be amended as it moves forward through the legislative process.

The two-member local committees proposed in AB 366 include a patient advocate and a non-treating psychiatrist. The bill may be redrafted to include a third person, MacNeil said.

Tyler noted that local committees to review involuntary medications were formerly in place at Napa State but stopped in last fall at DMH’s directive. That happened after a Coalinga State Hospital patient successfully challenged the practice, MacNeil said.

Disability Rights California, a statewide organization that advances the rights of Californians with disabilities, opposes the bill unless it is amended, Margaret Johnson, the nonprofit’s director of advocacy, said Thursday.

Disability Rights California wants to protect people’s rights to due process. “That’s our primary concern,” Johnson said.

She said Disability Rights California is in negotiations with Allen’s office. “We have been working with Michael Allen on suggested amendments,” she said.

Ronald Abernethy, Napa County’s chief public defender, expressed reservations about the bill, noting that “the issues surrounding the involuntary administration of anti-psychotic medication are complex.”

“The desire to authorize the involuntary medication of every mentally ill criminal defendant, the seeming goal of AB 366, is understandable,” Abernethy said in an email.

“Unfortunately, the statute offers few real protections of an individual’s constitutional right to be free, except in narrowly defined circumstances, from the forced administration of powerful drugs over a patient’s objection.

“Whether AB 366 in its current form would pass constitutional muster, under guidelines provided by the U.S. Supreme Court in the Sell decision, remains to be seen,” he said.

Jennifer Turner, spokeswoman for the Department of Mental Health, said the agency has not taken a position on AB 366.

URL: http://napavalleyregister.com/news/local/article_a8a04d66-777c-11e0-9f2c-001cc4c002e0.html

a

A report by the Mental Health Commission shows that more than half (57 per cent) of patients in acute or long-stay units were prescribed sedatives or benzodiazepines last year.

Clinical safety guidelines state that these drugs, which are typically used as medication for anxiety and as night sedation, should only be used after alternative therapies have been explored.

The commission’s report shows the rate of prescribing within individual psychiatric units ranged in some cases as high as 97 per cent.

It found that while the use of benzodiazepines has decreased slightly compared to figures collected in 2008, it continued to be high in many units.

“The lack of therapeutic services and programmes, as well as poor knowledge about the problems of benzodiazepine prescribing, may account for this,” the report found.

Inspection reports show that significant numbers of long-stay patients have been administered the drug for years even though guidelines state they should be used for the “shortest possible length of time and in the smallest possible dose”.

While small numbers of people may require benzodiazepines in the longer term, such as those who are severely dependent on them, the report says methods are available for withdrawing these kinds of patients from the drug.

It also found that the practice of combining more than one benzodiazepine was quite common (26 per cent of all residents) despite the lack of evidence of its therapeutic value.

Inspectors did, however, point out this practice has fallen significantly in recent years.

Former inspector of mental hospitals Dr Dermot Walsh yesterday said he had long-standing concerns regarding the overuse of these drugs.

“These are drugs of dependence and it’s clear they should only be used in short-term and acute situations, and usually for a very short period of time.

“It still amazes me when I see that patients are placed on these drugs almost on a routine basis when they come into hospital.”

He said the issue of benzodiazepines in medicine generally, especially primary care, was a problem.

The report also examines the use of anti-psychotic drugs which are used to treat symptoms of psychosis as well as schizophrenia and other mental health problems.

Inspectors found that 80 per cent of patients were receiving this form of medication.

Clinical guidelines advise against prescribing more than one anti-psychotic medication with limited exceptions. In its review inspectors found that 28 per cent of residents were receiving two or more anti-psychotic medications.

On a positive note, inspectors found that the practice of combining anti-psychotic medication is on the decrease and is below levels seen in international practice.

The use of doses of these medicines above the recommended dosage is also low (10 per cent) compared with international studies (in the UK it is about 20 per cent).

The report says there was evidence from a small number of centres that benzodiazepine prescribing had reduced and the quality of prescribing had increased following audits.

It says the vast majority of prescriptions authorising drugs to be administered to patients whenever it was required did not have a time limit or review date.

In its recommendations the report says each centre should conduct regular audits of medication prescribing and calls for training and education in safe prescribing.

URL: http://www.irishtimes.com/newspaper/ireland/2011/0504/1224296002783.html

a

MONTREAL – The Quebec College of Physicians has suspended and fined a psychiatrist and radio host who once told listeners blacks have low IQs and people with Down syndrome are lesser human beings.

Pierre Mailloux was also sanctioned for prescribing patients elevated doses of antipsychotic drugs. His licence was suspended for two years because of the megadose treatment that has been debunked in the psychiatric community for more than 10 years.

Mailloux often prescribed combinations of several antipsychotics, a practice the college denounced.

Mailloux was also fined $30,000 for racially charged, sexually graphic and off-the-cuff statements that have drawn the ire of regulators.

He was sanctioned by the Canadian Radio-Television and Telecommunications Commission in 2005 for telling the French CBC North American blacks have lower IQs than whites.

After signer Janet Jackson exposed her nipple at a 2004 Super Bowl concert, Mailloux said the singer’s behaviour was “typical of African or black people, who do not know how to behave even though they left Africa many years ago.”

He has also referred to Sikhs as “bozos,” Russians as thieves and Arabs as lazy.

The Broadcast Standards Council ruled against Mailloux for his November 2005 criticism of a television commercial that said people with Down syndrome were no less valuable to society than others.

“I find it degrading for normal people to be told they have the same value as someone who is truly abnormal and handicapped,” Mailloux said at the time.

The College of Physicians said Mailloux’s comments were “unworthy of a doctor and derogatory to the honour and the dignity of the profession.”

The College also said Mailloux has never apologized for his actions and will likely repeat them.

In an interview with QMI Agency on Friday, Mailloux said he will continue to speak out because he’s protected by free-speech provisions of the Charter of Rights.

“That’s my style,” said Mailloux, who quit the radio business in 2007. “Sometimes, I get vulgar. What’s the problem?”

While he is sometimes confronted in the street by ethnic Montrealers upset about his views, Mailloux says many listeners agree with him.

“I was on the air for 11 years, every afternoon” he said. “That should answer your question.”

As for his megadose treatments for mental illness, Mailloux says they’re effective despite the objections from his professional order.

“I am an avant-garde psychiatrist,” said Mailloux. “These are not medical errors and the proof that my treatments work is that I continue to treat these patients at their request.”
URl: http://www.torontosun.com/news/canada/2011/04/01/17842616.html

a

I’ve found this inspiring video on YouTube, and it personally hit a home run. It reminded me back when I was imprisoned in the psychiatric hospital, and that their was no way that I would be able to be released unless if I do everything that the “doctor” or nurse tells me. I was subject to take dangerous drugs, and if I refuse I get more time added on my stay; they thought that I was being too drastic, and because of my assertive behavior I needed more stay in the hospital, even know that I didn’t truly wanted to be there in the first place. They used “more time” as a weapon rather than treatment.

a

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

Please allow the video to load to prevent the video from lagging and cutting.

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.

a