Resperdal

Pharmaceutical Company Janssen Pharmaceutical
Program Address Janssen Cares - Resperdal Patient Assistant Program
4828 Parkway Plaza Blvd, Suite 220
Charlotte, NC 28217-1969
Toll Free Phone Number 800-652-6227
Alternate Phone Number 609-730-2000
Fax Number 704-357-0036
Guidelines and Notes For a couple, the income limit is $21,000, but Janssen takes out-of-pocket medical expenses into account. Generally, the cut off is 200% of the poverty level.
Initiating Enrollment

The patient, parent, guardian, physician or social worker can call for the application. Preliminary screening will be done over the phone.

The application may be copied. Janssen will fax or mail the application.

Health Provider's Role The doctor completes and signs the form. A prescription is part of the application. Request either 60 or 100 pills. The application may be faxed as long as the original is mailed.
Patient's Role Income and insurance information is requires. The patient must sign the application.
How Dispensed The medicine is sent to the doctor's office. Provide a street address, not a P. O. Box.
Amount Dispensed 60 or 100 pills
Estimated Response Time Not specified
Refills Re-apply every 6 months. Use a new application.
Limit Indefinite

Updated on: 10-28-98

Biological Psychiatry Has No Clothes!




Psychiatric Drug Facts
Peter R. Breggin, M.D.
Judges Reduce Sentences in Latest Paxil and Prozac Criminal Cases
January, 2002
In two recent criminal cases, judges have reduced the sentences for violent crimes committed under influence of antidepressants. In each case, the judges responded to expert testimony by psychiatrist Peter R. Breggin, M.D. concerning the adverse mental and behavior effects of SSRI antidepressants, specifically Prozac and Paxil. Both judges concluded that the medications contributed to the crimes and in post-conviction hearings they reduced the sentences of the two men.

Dr. Breggin has been an expert in other criminal and civil cases involving similar SSRI antidepressants, including Zoloft, Celexa and Luvox.

A Case of Paxil-Induced Mania and Aggression

In November 2001 in Charlestown, South Carolina, Dr. Breggin testified at a sentencing hearing before Judge Edward E. Cottinham. A 27-year-old man with no prior history of violence pleaded guilty to charges of rape. Dr. Breggin presented evidence that Paxil can cause mania with disinhibition and aggressive sexuality, and that a Paxil-induced Mood Disorder caused or contributed to the defendant's actions. Dr. Breggin described the FDA approval process and related topics. Despite his initial skepticism, the judge concluded that Paxil did contribute to the man's crime. Instead of sentencing him to two consecutive life sentences with no hope of parole, he gave him a more limited 21-year sentence with actual release in 19 years.

The hearing was held in the Charleston County General Sessions Court on November 15, 2001. The attorney for the defendant was Andrew Savage.

A Case of Prozac-Induced Violence
Earlier in 2001 in Abington, Virginia, Dr. Breggin testified in a jury trial presided over by Judge Charles H. Smith, Jr. The case involved a man who shot his estranged wife and a deputy sheriff who was trying to protect her. Fortunately, the victims recovered. However, the defendant was severely wounded in the shoot out. He faced many charges including kidnapping and malicious wounding. At the time of the incident, he was being treated with Prozac, Remeron, and BuSpar. Dr. Breggin testified on adverse drug reactions, drug labeling, FDA procedures, and criminal responsibility, including involuntary intoxication. The jury found the man guilty. Judge Smith, however, set a Virginia precedent by giving a jury instruction for involuntary intoxication. He also expressed appreciation for Dr. Breggin's testimony.

The sentencing hearing was held before Judge Smith in November 2001 and the judge gave the defendant a reduced sentence. In his written opinion, Judge Smith specifically cited Dr. Breggin's original testimony concerning the effect of the prescription drugs on the defendant's mental condition and behavior. The attorney for the defendant was Randall Eads.

Background Science
SSRI's (selective serotonin reuptake inhibitors) include Prozac, Paxil, Zoloft, Luvox and Celexa. Other antidepressants, such as Effexor, can also block the uptake of serotonin causing similar effects. These drugs can cause suicide, violence and other criminal acts through several mechanisms, including the following:
(1) SSRI-induced mania, sometimes (but not always) with psychotic features, such as hallucinations or delusions. During drug-induced mania, the individual can make elaborate plans, including robberies or embezzlement. However, the plans are often outlandish and doomed to failure due to obviously poor judgment. Drug-induced mania can cause many expressions of disinhibited or out-of-control behavior, including sexual acting out, road rage, buying sprees and shoplifting. Drug-induced mania, even when seemingly not intense, can ruin marriages and destroy careers. All of the features of mania are not required in order to meet the diagnosis of Antidepressant-Induced Mood Disorder with Manic Features. If the individual's mood is "elevated, euphoric, or irritable," the necessary criteria are met.
(2) SSRI-induced depression or worsening of depression. In a seemingly paradoxical effect, antidepressants can cause or worsen depression. In controlled clinical trials for Prozac that were conducted by the manufacturer, Eli Lilly and Company, depressed patients taking Prozac attempted suicide more frequently than depressed patients taking placebo (sugar pill) or older antidepressants.
(3) SSRI-induced severe anxiety and agitation, especially in a patient already suffering from depression with anxiety and agitation;
(4) SSRI-induced obsessions and compulsions that motivate violence toward oneself or others.
(5) SSRI-induced akathisia, an internal sensation of agitation or discomfort that drives a person to move about, and also to lose impulse control. During akathisia, the inner experience of agitation includes many unusual physical feelings, such as electricity in the head or body. The person suffering from akathisia typically feels compelled to move the feet when sitting, to stand, or to pace. Akathisia is known to increase the risk of suicide and violence. Dr. Breggin has been a medical expert in many malpractice, product liability and criminal cases involving SSRIs (see www.breggin.com for a limited selection). As a medical expert in 1994, Dr. Breggin provided the scientific basis for a large series of product liability cases alleging violence and suicide caused by Prozac. The court combined the cases in order to allow one organized effort at discovery. This facilitated the process of evaluating secret documents obtained from the company. In this lead role as the medical expert for the combined cases, Dr. Breggin reviewed internal documents from Eli Lilly & Company, the manufacturer of Prozac, and also examined FDA materials and the scientific literature. In a more recent product liability suit against Eli Lilly & Company, Dr. Breggin once again had the opportunity to examine internal documents, this time at the corporate headquarters. As far as Dr. Breggin is aware, all of the individual Prozac product liability suits in which he has agreed to be an expert have been settled or remain active. For documentation and further detailed discussion of the above summary, see the following three books by Peter R. Breggin, M.D.: (1) Talking Back to Prozac (with Ginger Breggin, 1994), Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock and the role of the FDA (1997), and (3) The Antidepressant Fact Book (2001).


http://www.guardian.co.uk/medicine/story/0,11381,764192,00.html

Antidepressant Seroxat tops table of drug withdrawal symptoms

Sarah Boseley, health editor
Saturday July 27, 2002
The Guardian
Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.

The committee on the safety of medicines, which receives reports of drug side-effects from doctors and pharmacists, has received an avalanche of complaints about Seroxat, one of the class of drugs known as SSRIs (selective serotonin reuptake inhibitors). The SSRIs, including Prozac, have always been marketed as safe medicines which are supposed not to cause the dependence problems that emerged with older drugs such as Valium and Ativan.

Seroxat - known generically as paroxetine - leads the top 20 table of drugs causing withdrawal problems, with 1,281 complaints from doctors under the "yellow card" scheme set up for the reporting of medicines' side-effects. More reports have been filed about Seroxat than about the rest of the top 20 put together. In the top six, five of the drugs said to be causing withdrawal problems are SSRIs - second after Seroxat comes Efexor (venlafaxine), with 272 complaints.

The figures were obtained from the medicines control agency, the regulatory authority which takes advice from the CSM, by the campaigning group Social Audit.

Charles Medawar of Social Audit has complained to the MCA and the CSM about the patient information leaflet supplied with Seroxat which he says is misleading and wrong. "These tablets are not addictive," the leaflet states, adding that the withdrawal problems some patients experience "are not common and are not a sign of addiction".

However, many people in the UK have consulted lawyers over the unexpected problems the drug caused them when they wanted to stop taking it. Mr Medawar drew to the MCA's attention the hundreds of postings on the group's website from people who have suffered and continue to suffer distressing symptoms as a result of trying to give up Seroxat. They complain of sensations that feel like electric shocks in the head, dizziness, mood swings, upset stomachs and unpleasantly vivid dreams, all of which are only alleviated by going back on the drug.

"I've been on Seroxat for about 10 years," wrote one woman in January, "and have tried to come off them on many occasions, only to find myself back to my original dose of 30mg because of the horrible withdrawals ... I was assured when talked into taking anti-depressants in the first place (that they) were one of the mildest and non addictive so-called 'wonder-drugs' in modern psychiatry!"

The SSRIs are commonly prescribed by GPs - not psychiatrists - to people who consult them with mild depression and sometimes other conditions, such as ME, anxiety and phobias.

Mr Medawar points out that the GPs are not warned of the withdrawal problems the drug can cause and often think the symptoms their patient suffers when stopping the medicine are just a return of their original ailment.

In a letter to Keith Jones, director of the MCA, he said that "the categorical and repeated assurance that Seroxat/paroxetine is not addictive seems to me completely unwarranted and highly likely to mislead and confuse patients and doctors alike. My view is that the MCA and CSM have failed the public and continue to fail the public - a gross dereliction of duty and responsibility to users, I would say".

In its response, the MCA acknowledges that the UK yellow card data shows a similar pattern to that of the World Health Organisation adverse drug reaction monitoring centre in Uppsala, Sweden, which put paroxetine at the top of the list and venlafaxine second in a table of withdrawal problems.

June Raine, who has responsibility at the MCA for the safety of licensed medicines, gave a clear indication that the agency may break with tradition and take into account complaints that come from patients as well as those from doctors and pharmacists.

http://www.bipolarworld.net/Phelps/ph_2000/ph85.htm
Dear Hugh
-- This is a very appropriate question. I think there are some very hefty differences, myself. Olanzapine has been approved by the FDA as a "mood stabilizer", based on numerous studies showing it treats bipolar I as well as a lithium comparison treatment. Nothing like that has been done for risperidone. When risperidone first came out, there quickly appeared several case reports of it inducing mania, much in the manner that antidepressants can do. In my experience, risperidone is a pretty darn good antidepressant: I've given it in microdoses, e.g. 0.5 mg twice a day (even 0.25mg once in a 45 year old woman who could get apparently hypomanic after two doses at 0.5mg!), and I believe I have seen rapid relief of depression, as well as relief of racing thoughts and insomnia. In my view, based on this kind of thing, I use it only with great caution in bipolar disorder.

http://www.bipolarworld.net/Phelps/ph_2000/ph94.htm But, can it cause manic symptoms? I don't know. It didn't take long after risperidone first came out to figure out that it can. And there are a few case reports that even Zyprexa can (a whole lot less often that risperidone, in my opinion, like night and day; but I digress). So, can Geodon? I wouldn't say no, that's for sure.


"Dwight and colleagues reported that six patients with Schizoaffective disorder all developed new or increased manic symptoms after about a week of risperidone treatment-and two of these patients were taking concomitant mood stabilizers." -------

First, make sure than none of the mood stabilizers is one that's been associated with causing hypomania. Yes, this occurs: Neurontin is the worst in this respect, lamotrigine also implicated in this way, topiramate probably also capable, Risperidone fairly widely accepted as commonly causing this problem, and even Zyprexa more rarely associated. That leaves lithium, Depakote and carbamazepine as basically the only really secure options. http://www.bipolarworld.net/Phelps/ph_2000/ph94.htm