Noise pollution and health

By any standard noise is annoying. I'd say the decibel level of city life is a bit more than I can take too much of since I live in a rural community of under 1000 people.

The other day a friend of mine near the Portland-Vancouver metro area suggested to a friend of hers driving to Pullman to visit his daughter at college. While her friend visits Cougarland, my friend would stay here.

In the conversation, he said, "There's nothing there!"

She replied, "That's why she (referring to me) lives there."

I guess noise is in the eye of the beholder.

Now today, for instance, I went to town, and as always, I am happy when I start heading home. It's the quiet you know.

No road rage for me amidst the 20,000 or so who inhabit that town about thirty minutes away.

Noise is a vibration. Its the vibration that constantly hack at your nervous system and lead to stress. The insidious, silent killer, about as deadly as diesel exhaust.

It could be today that it is deadlier because of the added stress caused by cell phones, cell towers, and wi-fi everywhere...

Pack up and head on out to the country, we have great home made pies at the cafe and real ice cream milkshakes.

And you will treasure the quiet, just like I do.

Noise of modern life blamed for thousands of heart deaths

· Stress of exposure adds to risks, says WHO report
· Light traffic is enough for chronic levels at night

* Alok Jha, science correspondent, The Guardian, Thursday August 23 2007

Thousands of people in Britain and around the world are dying prematurely from heart disease triggered by long-term exposure to excessive noise, according to research by the World Health Organisation. Coronary heart disease caused 101,000 deaths in the UK in 2006, and the study suggests that 3,030 of these are caused by chronic noise exposure, including to daytime traffic.

Deepak Prasher, professor of audiology at University College London, told the New Scientist magazine: "The new data provide the link showing there are earlier deaths because of noise. Until now, noise has been the Cinderella form of pollution and people haven't been aware that it has an impact on their health."

The WHO's working group on the Noise Environmental Burden on Disease began work on the health effects of noise in Europe in 2003. In addition to the heart disease link, it found that 2% of Europeans suffer severely disturbed sleep because of noise pollution and 15% can suffer severe annoyance. Chronic exposure to loud traffic noise causes 3% of tinnitus cases, in which people constantly hear a noise in their ears.

Research published in recent years has shown that noise can increase the levels of stress hormones such as cortisol, adrenaline and noradrenalin in the body, even during sleep. The longer these hormones stay in circulation around the bloodstream, the more likely they are to cause life-threatening physiological problems. High stress levels can lead to heart failure, strokes, high blood pressure and immune problems.

"All this is happening imperceptibly," said Prof Prasher. "Even when you think you are used to the noise, these physiological changes are still happening."

The WHO came to its figures by comparing households with abnormally high exposure to noise with those in quieter homes. It also studied people with problems such as coronary heart disease and tried to work out if high noise levels had been a factor in developing the condition. This data was then combined with maps showing the noisiest European cities.

According to the WHO guidelines, the noise threshold for cardiovascular problems is chronic night-time exposure of 50 decibels (dB) or above - the noise of light traffic. For sleep disturbance, the threshold is 42dB, for general annoyance it is 35dB, the sound of a whisper.

Ellen Mason, a cardiac nurse at the British Heart Foundation, said: "Our world is undoubtedly getting busier and noisier. Some people find noise pollution more stressful to live with than others do. Noise cannot directly kill us, but it may add to our stress. Occasionally, stressful events can trigger a heart attack in someone with underlying heart disease. We know that stressed people are more likely to eat unhealthily, exercise less and smoke more, and these can increase the risk of developing heart disease in the first place."

Mary Stevens, policy officer at the National Society for Clean Air, said of the study's results: "We welcome this because one of the problems with noise is that it's one of the areas that local authorities get most complaints about and it's a big draw on their resources. But, unlike air quality, it hasn't been taken that seriously policy-wise because there [wasn't] the link between noise and health."

Ms Stevens said that there were many options for reducing noise. Traffic could be quietened if more cars used low-noise tyres and councils installed low-noise road surfaces, for example. And coordinating roadworks by utility companies would also prevent the proliferation of potholes, another source of noisy traffic.

The EU has already issued a directive that obligates European cities with populations greater than 250,000 to produce digitised noise maps showing where traffic noise and volume is greatest. "[The research] all supports work going on at the moment to manage traffic noise, which is driven by the environmental noise directive," said Ms Stevens.

Skin Cream Alert

From Hippocrates Health Centre of Australia we received a report on the consequences of using Aldera cream for skin cancers, warts and genital warts, molluscum, actinic keratosis and related issues.

Aldera Side effects - http://www.rxlist.com/cgi/generic/imiquimod_ad.htm

We believe it is important to inform readers about the concerns with this product.

3M Pharmaceuticals are flogging ALDARA, a "cure" for skin cancer and genital warts, that can have cataclysmic side effects -- anaphylactic shock, irreversible autoimmune disease and even death.

The medical establishment and the media won't help -- Big Pharma are too rich and powerful. Only people power can stop 3M and the other multinationals in their greedy quest to dominate our fragile planet. Please help us spread the word. Click here for the truth about Aldara and send to everyone you know.

Asia urged to use vitamins and minerals to battle malnutrition

From the Flour Fortification Initiative (FFI)
"Malnutrition can cost the global economy between 180 to 250 billion dollars in healthcare costs over the next decade, the group said."

And at the same time the US FDA, Canadian Health Protection Board and other similar agencies are acting to block your access to vitamins and minerals that do protect your health.

I wonder what the cost in the US is from the nutritional deficiencies caused by prescription drugs?

Maybe you should wonder too...

The new diabetes generation and more

Adult psychiatric drug for the treatment of schizophrenia and bipolar disorder in children and adolescents.

Here's what most people on this drug don't get told...

www.rxlist.com/cgi/generic/risperid.htm
Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL®(risperidone) is not approved for the treatment of dementia-related psychosis (see BOXED WARNING).
Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases in which the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.

The management of NMS should include: (1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; (2) intensive symptomatic treatment and medical monitoring; and (3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.
Tardive Dyskinesia

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, RISPERDAL® (risperidone) should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that: (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient treated with RISPERDAL®, drug discontinuation should be considered. However, some patients may require treatment with RISPERDAL® despite the presence of the syndrome.
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients With Dementia-Related Psychosis

Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL® is not approved for the treatment of patients with dementia-related psychosis (See also BOXED WARNING, WARNINGS: Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)
Hyperglycemia and Diabetes Mellitus

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including RISPERDAL®. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.

Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
PRECAUTIONS
General
Orthostatic Hypotension

RISPERDAL® (risperidone) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its alpha-adrenergic antagonistic properties. Syncope was reported in 0.2% (6/2607) of RISPERDAL®-treated patients in Phase 2 and 3 studies. The risk of orthostatic hypotension and syncope may be minimized by limiting the initial dose to 2 mg total (either QD or 1 mg BID) in normal adults and 0.5 mg BID in the elderly and patients with renal or hepatic impairment (see DOSAGE AND ADMINISTRATION). Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. A dose reduction should be considered if hypotension occurs. RISPERDAL® should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia. Clinically significant hypotension has been observed with concomitant use of RISPERDAL® and antihypertensive medication.
Seizures

During premarketing testing, seizures occurred in 0.3% (9/2607) of RISPERDAL®-treated patients, two in association with hyponatremia. RISPERDAL® should be used cautiously in patients with a history of seizures.
Dysphagia

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s dementia. RISPERDAL® and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. (See also BOXED WARNING, WARNINGS: Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)
Hyperprolactinemia

As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Longstanding hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects.

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. An increase in pituitary gland, mammary gland, and pancreatic islet cell neoplasia (mammary adenocarcinomas, pituitary and pancreatic adenomas) was observed in the risperidone carcinogenicity studies conducted in mice and rats (see PRECAUTIONS – Carcinogenesis, Mutagenesis, Impairment of Fertility). Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time.
Potential for Cognitive and Motor Impairment

Somnolence was a commonly reported adverse event associated with RISPERDAL® treatment, especially when ascertained by direct questioning of patients. This adverse event is dose-related, and in a study utilizing a checklist to detect adverse events, 41% of the high-dose patients (RISPERDAL® 16 mg/day) reported somnolence compared to 16% of placebo patients. Direct questioning is more sensitive for detecting adverse events than spontaneous reporting, by which 8% of RISPERDAL® 16 mg/day patients and 1% of placebo patients reported somnolence as an adverse event. Since RISPERDAL® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that RISPERDAL® therapy does not affect them adversely.
Priapism

Rare cases of priapism have been reported. While the relationship of the events to RISPERDAL® use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to induce priapism, and it is possible that RISPERDAL® may share this capacity. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP)

A single case of TTP was reported in a 28 year-old female patient receiving RISPERDAL® in a large, open premarketing experience (approximately 1300 patients). She experienced jaundice, fever, and bruising, but eventually recovered after receiving plasmapheresis. The relationship to RISPERDAL® therapy is unknown.
Antiemetic Effect

Risperidone has an antiemetic effect in animals; this effect may also occur in humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye’s syndrome, and brain tumor.
Body Temperature Regulation

Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral RISPERDAL® use. Caution is advised when prescribing for patients who will be exposed to temperature extremes.
Suicide

The possibility of a suicide attempt is inherent in patients with schizophrenia and bipolar mania, including children and adolescent patients, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for RISPERDAL® should be written for the smallest quantity of tablets, consistent with good patient management, in order to reduce the risk of overdose.
Use in Patients With Concomitant Illness

Clinical experience with RISPERDAL® in patients with certain concomitant systemic illnesses is limited. Patients with Parkinson’s Disease or Dementia with Lewy Bodies who receive antipsychotics, including RISPERDAL®, are reported to have an increased sensitivity to antipsychotic medications. Manifestations of this increased sensitivity have been reported to include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with the neuroleptic malignant syndrome.

Caution is advisable in using RISPERDAL® in patients with diseases or conditions that could affect metabolism or hemodynamic responses. RISPERDAL® has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product's premarket testing.

Increased plasma concentrations of risperidone and 9-hydroxyrisperidone occur in patients with severe renal impairment (creatinine clearance <30 mL/min/1.73 m²), and an increase in the free fraction of risperidone is seen in patients with severe hepatic impairment. A lower starting dose should be used in such patients (see DOSAGE AND ADMINISTRATION).
Laboratory Tests

No specific laboratory tests are recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis

Carcinogenicity studies were conducted in Swiss albino mice and Wistar rats. Risperidone was administered in the diet at doses of 0.63, 2.5, and 10 mg/kg for 18 months to mice and for 25 months to rats. These doses are equivalent to 2.4, 9.4, and 37.5 times the maximum recommended human dose (MRHD) for schizophrenia (16 mg/day) on a mg/kg basis or 0.2, 0.75, and 3 times the MRHD (mice) or 0.4, 1.5, and 6 times the MRHD (rats) on a mg/m² basis. A maximum tolerated dose was not achieved in male mice. There were statistically significant increases in pituitary gland adenomas, endocrine pancreas adenomas, and mammary gland adenocarcinomas. The following table summarizes the multiples of the human dose on a mg/m² (mg/kg) basis at which these tumors occurred.

Multiples of Maximum
Human Dose in mg/m²
(mg/kg)
Tumor Type Species Sex Lowest
Effect Level Highest No-
Effect Level
Pituitary adenomas mouse female 0.75 (9.4) 0.2 (2.4)
Endocrine pancreas adenomas rat male 1.5 (9.4) 0.4 (2.4)
Mammary gland adenocarcinomas mouse female 0.2 (2.4) none
rat female 0.4 (2.4) none
rat male 6.0 (37.5) 1.5 (9.4)
Mammary gland neoplasm, Total rat male 1.5 (9.4) 0.4 (2.4)

Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Serum prolactin levels were not measured during the risperidone carcinogenicity studies; however, measurements during subchronic toxicity studies showed that risperidone elevated serum prolactin levels 5-6 fold in mice and rats at the same doses used in the carcinogenicity studies. An increase in mammary, pituitary, and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin-mediated. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown (see PRECAUTIONS, General -Hyperprolactinemia).
Mutagenesis

No evidence of mutagenic potential for risperidone was found in the Ames reverse mutation test, mouse lymphoma assay, in vitro rat hepatocyte DNA-repair assay, in vivo micronucleus test in mice, the sex-linked recessive lethal test in Drosophila, or the chromosomal aberration test in human lymphocytes or Chinese hamster cells.
Impairment of Fertility

Risperidone (0.16 to 5 mg/kg) was shown to impair mating, but not fertility, in Wistar rats in three reproductive studies (two Segment I and a multigenerational study) at doses 0.1 to 3 times the maximum recommended human dose (MRHD) on a mg/m² basis. The effect appeared to be in females, since impaired mating behavior was not noted in the Segment I study in which males only were treated. In a subchronic study in Beagle dogs in which risperidone was administered at doses of 0.31 to 5 mg/kg, sperm motility and concentration were decreased at doses 0.6 to 10 times the MRHD on a mg/m² basis. Dose-related decreases were also noted in serum testosterone at the same doses. Serum testosterone and sperm parameters partially recovered, but remained decreased after treatment was discontinued. No no-effect doses were noted in either rat or dog.
Pregnancy
Pregnancy Category C

The teratogenic potential of risperidone was studied in three Segment II studies in Sprague-Dawley and Wistar rats (0.63-10 mg/kg or 0.4 to 6 times the maximum recommended human dose [MRHD] on a mg/m² basis) and in one Segment II study in New Zealand rabbits (0.31-5 mg/kg or 0.4 to 6 times the MRHD on a mg/m² basis). The incidence of malformations was not increased compared to control in offspring of rats or rabbits given 0.4 to 6 times the MRHD on a mg/m² basis. In three reproductive studies in rats (two Segment III and a multigenerational study), there was an increase in pup deaths during the first 4 days of lactation at doses of 0.16-5 mg/kg or 0.1 to 3 times the MRHD on a mg/m² basis. It is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams.

There was no no-effect dose for increased rat pup mortality. In one Segment III study, there was an increase in stillborn rat pups at a dose of 2.5 mg/kg or 1.5 times the MRHD on a mg/m²basis. In a cross-fostering study in Wistar rats, toxic effects on the fetus or pups, as evidenced by a decrease in the number of live pups and an increase in the number of dead pups at birth (Day 0), and a decrease in birth weight in pups of drug-treated dams were observed. In addition, there was an increase in deaths by Day 1 among pups of drug-treated dams, regardless of whether or not the pups were cross-fostered. Risperidone also appeared to impair maternal behavior in that pup body weight gain and survival (from Day 1 to 4 of lactation) were reduced in pups born to control but reared by drug-treated dams. These effects were all noted at the one dose of risperidone tested, i.e., 5 mg/kg or 3 times the MRHD on a mg/m² basis.

Placental transfer of risperidone occurs in rat pups. There are no adequate and well-controlled studies in pregnant women. However, there was one report of a case of agenesis of the corpus callosum in an infant exposed to risperidone in utero. The causal relationship to RISPERDAL® therapy is unknown. Reversible extrapyramidal symptoms in the neonate were observed following postmarketing use of risperidone during the last trimester of pregnancy.

RISPERDAL® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery

The effect of RISPERDAL® on labor and delivery in humans is unknown.
Nursing Mothers

In animal studies, risperidone and 9-hydroxyrisperidone are excreted in milk. Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving risperidone should not breast-feed.
Pediatric Use

The safety and effectiveness of RISPERDAL® in pediatric patients with schizophrenia or bipolar mania have not been established.

The efficacy and safety of RISPERDAL® in the treatment of irritability associated with autistic disorder were established in two 8-week, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years (see CLINICAL PHARMACOLOGY - Clinical Trials, INDICATIONS AND USAGE, and ADVERSE REACTIONS). Additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1200 pediatric patients with other psychiatric disorders who were of similar age and weight, and who received similar dosages of RISPERDAL® as patients who were treated for irritability associated with autistic disorder.

The safety and effectiveness of RISPERDAL® in pediatric patients with autistic disorder less than 5 years of age have not been established.
Tardive Dyskinesia

In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorders treated with risperidone, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of risperidone treatment (see WARNINGS – Tardive Dyskinesia).
Weight Gain

In long-term, open-label trials (studies in patients with autistic disorder or other psychiatric disorders), a mean increase of 7.5 kg after 12 months of RISPERDAL® treatment was observed, which was higher than the expected normal weight gain (approximately 3 to 3.5 kg per year adjusted for age, based on Centers for Disease Control and Prevention normative data). The majority of that increase occurred within the first 6 months of exposure to RISPERDAL®. The average percentiles at baseline and 12 months, respectively, were 49 and 60 for weight, 48 and 53 for height, and 50 and 62 for body mass index. When treating patients with RISPERDAL®, weight gain should be assessed against that expected with normal growth. (See also ADVERSE REACTIONS.)
Somnolence

Somnolence was frequently observed in placebo-controlled clinical trials of pediatric patients with autistic disorder. Most cases were mild or moderate in severity. These events were most often of early onset with peak incidence occurring during the first two weeks of treatment, and transient with a median duration of 16 days. (See also ADVERSE REACTIONS.) Patients experiencing persistent somnolence may benefit from a change in dosing regimen (see DOSAGE AND ADMINISTRATION – Irritability Associated with Autistic Disorder).

Hyperprolactinemia, Growth, and Sexual Maturation

Risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults (see PRECAUTIONS - Hyperprolactinemia). In double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) 49% of patients who received risperidone had elevated prolactin levels compared to 2% of patients who received placebo.

In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorders treated with risperidone, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients.

The long-term effects of risperidone on growth and sexual maturation have not been fully evaluated.
Geriatric Use

Clinical studies of RISPERDAL® in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). While elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.5 mg BID followed by careful titration (see PRECAUTIONS). Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern.

This drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).
Concomitant use with Furosemide in Elderly Patients with Dementia-Related Psychosis

In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone when compared to patients treated with risperidone alone or with placebo plus furosemide. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed. An increase of mortality in elderly patients with dementia-related psychosis was seen with the use of RISPERDAL® regardless of concomitant use with furosemide. RISPERDAL® is not approved for the treatment of patients with dementia-related psychosis. (See BOXED WARNING, WARNINGS: Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)
Next: Risperdal - Overdosage & Contraindications »
« Previous: Risperdal - Side Effects & Drug Interactions

FDA Approves Adult Psychiatric Drug for Use on Adolescent Patients
(AP) 02:23:21 PM (ET), Wednesday, August 22, 2007 (WASHINGTON)

The Food and Drug Administration on Wednesday approved a widely used adult psychiatric drug for the treatment of schizophrenia and bipolar disorder in children and adolescents.

The action permits use of Risperdal for schizophrenia in youths aged 13 to 17 and for bipolar disorder in those aged 10 to 17, FDA said.

It was approved last fall for treatment of irritability in autism.

Risperdal, manufactured by Janssen, L.P. of Titusville, N.J., is the No. 3 anti-psychotic drug, with $2.3 billion in sales in 2005, according to the pharmaceutical data company IMS Health. Janssen is a unit of Johnson & Johnson.

Risperdal was approved for use in adults in 1993.

Until now, FDA said, there has been no approved drug for the treatment of schizophrenia in youths and only lithium is approved for the treatment of bipolar disorder in adolescents.

The dose approved for youths is slightly lower than the adult dose, FDA said.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported, the agency said.

Almonds Amended

In the post below on cyanide compounds in berries and fruit I mention this move to destroy almonds as a healing food because of blind government intervention.

Here is an update on the issue. Please take action.

New FDA Law Requires Organic Almond Pasteurization
From Rich Johansen, 8-21-7

Today, Monday, August 20, 2007 many Almond Farmers attended a meeting in Modesto, California that sealed the future of Almond crops everywhere. What food will be next?

Description/History -

Starting in August or September of 2007, raw almonds available in the USA, Canada and Mexico, will no longer be "truly raw" due to a mandate passed by the USDA, FDA and the California Almond Board, announcing that all almonds including organic must be pasteurized. This means that the Almond farmer will have to truck thousands of pounds of almonds to one of the five facilities that are already set up for the pasteurization process and then truck them back again to the processing plant. Besides having a vital part of our food supply pasteurized--against our will, it will now have a huge cost attached to it. Information is available at the following link:

http://www.almondboard.com/Programs/content.cfm
?ItemNumber=890&snItemNumber=450

Action Plan and Pasteurization - Frequently Asked Questions

The problem is the law has been passed with little public input (if any) or notification whatsoever.

In addition, all pasteurized almonds available in the marketplace will still be labeled as raw almonds. Can this be considered fraudulence or an outright lie? Are you willing to give up your food freedom choices?

The primary reasons for passing this law are two isolated outbreaks of salmonella, in conjunction with conventional almond farms a few years ago. To the best of our knowledge no salmonella outbreaks have EVER been associated with organic almonds.

Within the past 10 years tomatoes, spinach, green onions, peanuts, grapes, melons, lettuce, and sprouts have all been linked to salmonella outbreaks. Does that mean we should eliminate all fresh produce? Absolutely not!!! But they are going to try.

Almonds, the heartbeat of all nuts, literally, have been associated with reduced risk of heart disease, a rich source of calcium, magnesium, vitamin E, protein, fiber and antioxidants to name a few . These amazing and life enhancing health benefits, will be devastatingly reduced if not completely eliminated in the pasteurization process.

Three of the potential suggested methods of pasteurization are:

- Propylene Oxide (PPO) Fumigation (propylene oxide was also used as an insecticidal fumigant till 1988 when its registration was terminated. California Prop.65 rates PPO as a CARCINOGEN. (Cited from www.mbow.org)

- High Heat (which degrades the integrity of the nuts and enzyme structure).

- Steam Pasteurization (will also further devalue the nutrients, enzyme activity and antioxidants.)

This is a call to all those who care about their health, we need to join forces by bringing this to the attention of everyone from the mass media to the common consumer before it goes any further than almonds! It is our basic right to choose unprocessed foods! We have created a petition that we will present to the California Almond Board, the FDA and the USDA. Go to www.livingnutz.com and click on the almond pasteurization petition link on the front of our page and sign your name as well as your state, town, and zipcode. E-mail us at info@livingnutz.com This e-mail address is being protected from spam bots, you need JavaScript enabled to view it with any other questions, media relations, ideas or information you may have relevant to this cause.

Just say NO. Shout it, write it, Do not put up with this crime against humanity!

The Pain in Spain is Mainly in the Main

As a former critical care nursing practitioner the issue of pain is one of familiarity. Reading this article I can say that most of what the writer says is very accurate. My question is: "Why nothing but pills?"

I now work only with natural health approaches, and have used many natural approaches to pain for my clients with good benefit. I educate many people about pain treatment options too.

I've been injured and have had to manage pain, but have the benefit of knowing what to do to work with it. My approach is not to deaden the nerves to stop pain perception, but to nourish them so they heal. Then pain is resolved, not managed.

I knew someone in law enforcement was severely injured in the apprehension of a criminal. He was a tall,large man. His degree of pain required something very different than a woman of 80 weighing 100 pounds. His career was destroyed by an over-aggressive Washington state investigation, eventually proven to be nothing more than a political attack. He was making an effort to clean up the sheriff's department and the powers that be wanted the door kept closed. The prosecutor that lost this case was the same one who allowed a perpetrator to get free of a charge of arson on my home.

People are harmed by suffering with pain. Prescribers need to know their patients well enough to take a stand for them having the kind and amount of pain medication appropriate for good care. Physicians need to be in charge of medicine, not insurers.

Those believing that every one on pain medication is an addict need to research why the war on drugs never worked.

First, do no harm.

AP IMPACT: Analysis Finds Pain Medicine Use Has Risen by 90 Percent
By FRANK BASS Associated Press Writer
(AP) 09:00:13 AM (ET), Monday, August 20, 2007 (MYRTLE BEACH, S.C.)

People in the United States are living in a world of pain and they are popping pills at an alarming rate to cope with it.

The amount of five major painkillers sold at retail establishments rose 90 percent between 1997 and 2005, according to an Associated Press analysis of statistics from the Drug Enforcement Administration.

More than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores during the most recent year represented in the data. That total is enough to give more than 300 milligrams of painkillers to every person in the country.

Oxycodone, the chemical used in OxyContin, is responsible for most of the increase. Oxycodone use jumped nearly six-fold between 1997 and 2005. The drug gained notoriety as "hillbilly heroin," often bought and sold illegally in Appalachia. But its highest rates of sale now occur in places such as suburban St. Louis, Columbus, Ohio, and Fort Lauderdale, Fla.

The world of pain extends beyond big cities and involves more than oxycodone.

In Appalachia, retail sales of hydrocodone _ sold mostly as Vicodin _ are the highest in the nation. Nine of the 10 areas with the highest per-capita sales are in mostly rural parts of West Virginia, Kentucky or Tennessee.

Suburbs are not immune to the explosion.

While retail sales of codeine have fallen by one-quarter since 1997, some of the highest rates of sales are in communities around Kansas City, Mo., and Nashville, Tenn., and on New York's Long Island.

The DEA figures analyzed by the AP include nationwide sales and distribution of drugs by hospitals, retail pharmacies, doctors and teaching institutions. Federal investigators study the same data trying to identify illegal prescription patterns.

An AP investigation found these reasons for the increase:

_The population is getting older. As age increases, so does the need for pain medications. In 2000, there were 35 million people older than 65. By 2020, the Census Bureau estimates the number of elderly in the U.S. will reach 54 million.

_Drugmakers have embarked on unprecedented marketing campaigns. Spending on drug marketing has gone from $11 billion in 1997 to nearly $30 billion in 2005, congressional investigators found. Profit margins among the leading companies routinely have been three and four times higher than in other Fortune 500 industries.

_A major change in pain management philosophy is now in its third decade. Doctors who once advised patients that pain is part of the healing process began reversing course in the early 1980s; most now see pain management as an important ingredient in overcoming illness.

Retired Staff Sgt. James Fernandez, 54, of Fredericksburg, Va., survived two helicopter crashes and Gulf War Syndrome over 20 years in the Marine Corps. He remains disabled from his service-related injuries and takes the equivalent of nine painkillers containing oxycodone every day.

"It's made a difference," he said. "I still have bad days, but it's under control."

Such stories should hearten longtime advocates of wider painkiller use, such as Russell Portenoy, head of New York's Beth Israel pain management department. But they have not.

"I'm concerned and many people are concerned," he said, "that the pendulum is swinging too far back."

Consider:

_More people are abusing prescription painkillers because the medications are more available. The vast majority of people with prescriptions use the drugs safely. But the number of emergency room visits from painkiller abuse has increased more than 160 percent since 1995, according to the government.

_Spooked by high-profile arrests and prosecutions by state and federal authorities, many pain-management specialists now say they offer guidance and support to patients but will not write prescriptions, even for the sickest people. The increase in painkiller retail sales continues to rise, but only barely. There was a 150 percent increase in volume in 2001. Four years later, the year-to-year increase was barely 2 percent.

_People who desperately need strong painkillers are forced to drive a long way _ often to a different state _ to find doctors willing to prescribe high doses of medicine. Siobhan Reynolds, the widow of a New Mexico patient who needed large amounts of painkillers for a connective tissue disorder, said she routinely drove her late husband to see an accommodating doctor in Oklahoma.

Perhaps no place illustrates the trends and consequences for the world of pain better than Myrtle Beach, a sprawling community of strip malls, hotels and bars perched along a 60-mile strip of sand on the Atlantic Ocean. The metro area, which includes three counties, is home to 350,000 people but sees more than 14 million tourists annually, drawn to its warm water, golf courses and shopping.

During the eight-year period reflected in government figures, oxycodone distribution increased 800 percent in the area of Myrtle Beach, partly due to a campaign by Purdue Pharmaceuticals of Stamford, Conn. The privately held company has pleaded guilty to lying to patients, physicians and federal regulators about the addictive nature of the drug.

Use of other drugs soared in the area, too: Hydrocodone use increased 217 percent; morphine distribution went up 180 percent; even meperidine, most commonly sold as Demerol, jumped 20 percent.

It is no small wonder that federal authorities suspected the area was home to a notorious "pill mill," or a clinic that dispenses prescription medication without verifying that it's needed.

The U.S. attorney for South Carolina secured a 58-count indictment in June 2002 against seven physicians and one employee of the Comprehensive Care and Pain Management Center, a nondescript storefront on Myrtle Beach's main drag.

Tipped off by local pharmacists concerned about an increase in the volume of painkiller prescriptions, the federal investigation created a furor in the medical profession. The owner, D. Michael Woodward, was sentenced to 15 years in the case and has relinquished his license.

A second physician, Deborah Bordeaux, had worked at the clinic less than two months before quitting in disgust. Bordeaux, now serving a two-year prison term, was threatened with a 100-year sentence if she did not help the prosecution.

Officials with the Justice Department and the DEA would not discuss what some activists say is a "war on doctors."

Reynolds, the widow who drove her late husband hundreds of miles for his pills, became an activist after the Myrtle Beach indictments. She contributed money to appeal some of the criminal convictions in South Carolina and started the Pain Relief Network, an advocacy organization for people living in pain. She believes the doctors sent to prison were railroaded.

"It was a witch hunt," she said.

Bordeaux's husband, Edworth Swaim, agrees. A retired U.S. Postal Service employee, Swaim believes his wife was sentenced to two years because she would not turn on her former colleagues. Even though Bordeaux had worked at the clinic less than two months and eventually sued over what she alleged was rampant Medicare fraud, he said she did not stand a chance of avoiding prison.

"She wasn't guilty of anything, so she wasn't going to plead to anything," Swaim said. "She was absolutely railroaded, made an example of. I can't tell you how angry I am."

Myrtle Beach physicians are not convinced that the "Myrtle Beach Eight," as they became known, were innocent.

A Myrtle Beach internist who also works in addiction medicine, Brian Adler, said physicians were flooded with patients seeking pain medicine after the clinic was shut down.

The community has a slightly higher-than-average number of older people and relatively high numbers of people between 21 and 64 who describe themselves as disabled.

"There's a significant problem with narcotics in this area," Adler said. After the pain management clinic closed, "all those folks were like rats, scurrying from a burning building, trying to get their fix."

Other physicians were concerned about patients with legitimate needs for painkillers. The federal bust raised the stakes.

When radio commentator Rush Limbaugh settled a federal case charging him with illegally obtaining painkillers, he did not get prison time. Neither did NFL star Brett Favre, who publicly acknowledged an addiction to Vicodin that he obtained legally.

To pain management specialists, they were being blamed for everyone's addiction.

The DEA cites 108 prosecutions of physicians during the past four years; 83 pleaded guilty or no contest, while 16 others were convicted by juries. Eight cases are pending, and one physician is being sought as a fugitive.

In congressional testimony, the agency's deputy assistant administrator, Joseph T. Rannazzisi, estimated that fewer than 1 percent of the nation's physicians _ under 9,000 _ illegally provide prescription drugs to patients. He told lawmakers it is far more common for people to illegally obtain prescription drugs from friends and family members.

"It is not merely illegal but could feed or lead to an addiction and place that loved one in a life-threatening situation," Rannazzisi said.

It is impossible to reliably measure painkiller abuse.

A 2004 government study estimated between 2 million and 3 million doses of codeine, hydrocodone and oxycodone are stolen annually from pharmacies, distributors and drug manufacturers. The AP's analysis only included retail sales and did not include estimates of diverted pharmaceuticals.

John Charles, director of medical affairs at the Grand Strand Regional Medical Center in Myrtle Beach, practices pain management. A few years ago, Charles said, he took a drastic step to reduce his potential legal risks: He stopped prescribing painkillers.

The decision gave him peace of mind, but he does not expect there to be less of a need for painkillers or physicians who prescribe them.

"People with cancer are surviving longer, elderly people are living longer," Charles said. "So, physicians are walking a fairly fine line. We're walking a narrow path. And I think we'll continue to see it for a while."

Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

More to trans fat than you know now

In an effort to stop the ingestion of trans fat, which may be a good idea in the long run, diet dictocrats often seem to overlook the problem with canola.

A plant oil canola is. A healthy food it is not.

There is a toxic-to-the-liver substance known as Eurycic acid. This compound is the result of processing canola seed, a member of the mustard family.

When canola is processed, the processing causes the oil to become a trans-fat. The Eurycic acid is found at 4%, when at a 2% level it becomes toxic to the liver.

Additionally, oils packaged in plastic, because of heat and light exposure such as on the supermarket shelf, tend to cause transfer of xenoestrogens from the plastic to the oil. Xenoestrogens are carcinogenic.

Read your labels and watch out for canola, it is pervasive in the food supply.

I use this oil in mt truck as a fuel additive, giving me and extra 6 miles per gallon so far.

'Zero Grams Trans Fat' Doesn't Always Mean Zero When It Comes to Food Labels By STEPHANIE NANO
Associated Press Writer
(AP) 04:57:47 PM (ET), Sunday, August 19, 2007 (NEW YORK)

Stroll the aisles of any grocery store and you're sure to spot labels declaring "zero grams trans fat" on the front of snack foods, cookies and crackers. But does zero really mean there's NO artery-clogging fat inside?

Maybe, maybe not.

Federal regulations allow food labels to say there's zero grams of trans fat as long as there's less than half a gram per serving. And many packages contain more than what's considered one serving.

"The problem is that often people eat a lot more than one serving," said Dr. Dariush Mozaffarian of Harvard School of Public Health. "In fact, many people eat two to three servings at a time."

Those small amounts of trans fat can add up, said Michael Jacobson of the consumer advocacy Center for Science in the Public Interest. To find out if there might be some trans fat, he said shoppers can check the list of ingredients to see if partially hydrogenated oil _ the primary source of trans fat _ is included.

"When it says zero grams, that means something different from no trans fat," said Jacobson. His group has urged the government to bar food producers from using any partially hydrogenated oils at all.

The Food and Drug Administration began forcing food companies to list the amount of trans fat on nutrition labels of packaged foods in January 2006. That led many companies to switch to alternative fats.

Trans fat occurs naturally in some dairy and meat products, but the main source is partially hydrogenated oils, formed when hydrogen is added to liquid vegetable oils to harden them.

Consumer groups and health officials have campaigned to get rid of trans fat because it contributes to heart disease by raising levels of LDL or bad cholesterol while lowering HDL or good cholesterol. Fast-food restaurants are switching to trans fat-free oils and New York City and Philadelphia are forcing restaurants to phase out their use of trans fat.

The American Heart Association recommends that people limit trans fats to less than 2 grams per day.

Julie Moss of the FDA's Office of Nutrition, Labeling and Dietary Supplements, said the half-gram threshold for labeling was adopted because it is difficult to measure trans fat at low levels and the same half-gram limit is used for listing saturated fat. She said the FDA would soon be doing consumer research on trans fat labeling, including whether a footnote such as "Keep your intake of trans fat as low as possible" should be added to food labels.

Robert Earl of the Grocery Manufacturers Association said any trans fat in products labeled zero trans fat is likely to be far less than the half-gram threshold. For example, he said, a little partially hydrogenated oil might be used to help seasoning stick.

"I think the industry has been extremely responsive. Most of them were ahead of the curve to either remove or reduce trans fat in most food products," he said.

Earl said shoppers should be looking at the entire food label.

Jacobson is also concerned that people are focusing too much on the trans fat content alone, and not considering other ingredients such as saturated fat, which also raises the risk of heart disease.

"The bigger problem is foods that have no labels at all," Mozaffarian said, citing food served not only at restaurants, but at bakeries, cafeterias and schools.

New York resident Diana Fiorini said she's just recently started paying attention to labels. Holding a box of microwave popcorn at a Manhattan store, she scanned the label and was happy to see that it listed zero grams trans fat.

"I look at the labels. It's still hard to stop yourself when you know you should," she said.