Archive for July, 2008

Champix May Have Led To TV Editors Suicide

Tuesday, July 8th, 2008

A coroner has linked an anti-smoking drug to the death of a television editor who killed himself.
Omer Jama, 39, who worked for Sky Sports, was found dead at his home two months after being prescribed Champix to help him quit smoking.
An inquest in Bolton was told that Mr Jama had slashed his wrists and stabbed himself in the thigh and stomach.
However, the coroner, Jennifer Leeming, said she could not record a verdict of suicide and instead recorded an open verdict.
She said: "For me to register that he took his own life I would have to be satisfied he did the act which led to his death and he knew what he was doing."
"On the evidence before me I cannot say that was the case."
She said that she would write to the European Medicines Agency (EMA), which has been monitoring Champix since it was authorised in the EU in September 2006, to register the death as an "adverse event."
Julie Evans, a forensic toxicology expert, told the inquest that traces of the drug in Mr Jama’s blood did not indicate an overdose. But she said reports from the United States had recorded "suicidal" thoughts in patients.
She said: "There is a possibility he could have been influenced by the side effects of the drug."
The EMA, which licensed the drug, issued guidance on its active ingredient, varenicline, to doctors two months after Mr Jama’s death last October.
generic diflucan online buy It said "updated warnings" were needed to raise awareness of cases of suicide attempts reported in patients after the drug was allegedly linked to 37 US suicide cases.
Last year, the EMA received 839 reports of adverse reactions, of which 46 were linked to depression and 16 to patients claiming to have suffered suicidal thoughts.
His brother, Ali Jama, 41, said: "It is clear from the evidence of the toxicologist that Champix’s influence could have played a part. I would like to see more investigation done."
A spokesman for Pfizer, the makers of Champix, said, no causal link had been established between the drug and depression.
He said: "Depression, rarely including suicidal ideation [suicidal thoughts], has been reported in patients undergoing a smoking cessation attempt. These symptoms have also been reported while quitting with varenicline. A relationship between varenicline and the reported symptoms hasn’t been established but in some reports a link couldn’t be excluded."
In February, the National Institute for Health and Clinical Excellence recommended that the drug should be prescribed to smokers wanting to kick their habit. However, it said the full side effects of Champix were not yet known.

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Troublesome Allergens Thrive In Humid Weather

Tuesday, July 8th, 2008

About 40 million Americans suffer from "hay fever," a disease that allergists prefer to call "allergic rhinitis," because HAY is not to blame and FEVER is rarely a symptom.
So what is causing the stuffy runny nose, the watery itchy eyes, the sneezing, wheezing and cough, and why are heavy rains and melting snow making symptoms worse?
"There are dozens of substances that potentially can cause trouble in those of us who are susceptible to allergies, but trees are usually the first on the scene during spring allergy season," said Jay M. Portnoy, M.D., president of the American College of Allergy, Asthma and Immunology (ACAAI) and chief, section of allergy, asthma & immunology at Children’s Mercy Hospitals & Clinics in Kansas City, Mo. "Rain can provide some initial relief by reducing tree pollen counts, but it also can spur the growth of grass and weeds later in the spring and in early summer, producing more pollen."
Paul Ratner, M.D., Medical Director of Sylvana Research in San Antonio, Texas, said "A dry and cold winter followed by recent heavy rains has resulted in a slightly delayed onset of spring tree pollens. The primary tree pollen, Oak, began appearing mid-March, and within a week, extremely high pollen counts were recorded. The tree pollen season is expected to last through early May."
Heavy precipitation in many areas of the U.S. is associated with a greater release of seasonal pollens according to Clifford W. Bassett, M.D., a fellow of the ACAAI and a clinical assistant professor of medicine at the Long Island College Hospital in Brooklyn, N.Y.
"We are seeing many patients over the past several weeks, both adults and children, with complaints that may be difficult for them to differentiate from a cold, allergy or sinus problem. Once they are diagnosed with a seasonal allergy, an individual allergy treatment program can be prescribed for their relief," Dr. Bassett said.
"Last year we had record high pollen levels in New York City and expect that trend to continue. It’s very important to begin treatment before symptoms progress," he said.
There has been a prolonged snow cover on the ground from mid-November through mid-March said ACAAI President-Elect Richard G. Gower, M.D., Marycliff Allergy Specialists in Spokane, Wash. "Melting snow has revealed an abundance of outdoor mold growth and the use of indoor humidifiers has contributed to increased indoor mold counts. Trees began pollinating in early February and will continue through June, overlapping with our grass season in May and June."
The five most common allergens, according to the ACAAI are:
1. Trees produce pollen, the dust-like, male reproductive parts of plants that cause most allergies. In some southern states, trees can produce pollen as early as January, while pollen production usually begins in April in the north. The oak tree, which is prevalent throughout the United States, produces large quantities of pollen and is a major cause of allergies. Evergreens also can be troublemakers. Cedar, juniper, cypress and sequoia trees have all been known to cause allergies and if you’re allergic to one, you may be allergic to them all. Other suspects include elm trees, which are common in the eastern and midwestern regions, birch trees, olive trees, sycamores, and poplars, including cottonwoods, balsam and aspen.
2. Grasses usually come along to stir up allergy symptoms after trees are through pollinating typically from late spring to early summer. Common culprits are timothy grass, Bermuda grass, sweet vernal, red top and some blue grasses.
3. Weeds are guilty of causing most of the allergy misery that occurs in the late summer and early fall. Buy lexapro without prescription Top on the list of offenders is ragweed which affects as many as 75 percent of all hay fever sufferers. Ragweed is found in virtually every region of the United States and, with 17 different species of the weed, there’s plenty of pollen to keep people sneezing and sniffling until frost. Other common weed allergens are sagebrush, found predominantly in the west, pigweed and goosefoot pollen.
4. Molds are microscopic plants that reproduce by sending tiny spores into the air. They thrive in areas that are warm, dark and moist. Unlike pollen, which appears only in the warm weather months, mold can lurk in your house year-round.
5. Dust Mites are small (hundreds can live in a single gram of dust), eight-legged creatures that belong to the same family as spiders, chiggers and ticks. These culprits are hardy creatures that live well and multiply easily in warm, humid places. Favorite hideouts include carpets, upholstered furniture, bedding, clothes, soft toys and the fur of pets. The intruder is particularly malicious when trapped inside a closed-up house.
An allergist-immunologist is a physician who specializes in the diagnosis and treatment of asthma and other allergic diseases. The allergist is specially trained to identify the allergic and non-allergic factors that trigger asthma and other allergic diseases. Allergists help people treat or prevent their allergy problems. After earning a medical degree, the allergist-immunologist completes a three-year residency training program in either internal medicine or pediatrics. Next the allergist completes two or three more years of study in the field of allergy-immunology in order to prepare for certification by the American Board of Allergy and Immunology.
The American College of Allergy, Asthma and Immunology (ACAAI) is a professional medical organization headquartered in Arlington Heights, Ill., that promotes excellence in the practice of the subspecialty of allergy and immunology. The College, comprising more than 5,000 allergists-immunologists and related health care professionals, fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research.
American College of Allergy, Asthma and Immunology (ACAAI)
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States

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Study Demonstrates Lexapro(R) Significantly Improves Depression Symptoms In Adolescents

Tuesday, July 8th, 2008

Forest Laboratories, Inc.
(NYSE: FRX) announced that study results show Lexapro (escitalopram
oxalate) significantly improved symptoms of depression as compared to
placebo treatment and was well tolerated in adolescents, aged 12-17, with
major depressive disorder (MDD), according to phase III data presented at
the 2008 Annual Meeting of the American Psychiatric Association. These
results suggest that Lexapro has potential as a useful treatment option for
adolescents with
depression. Top-line results of this study were initially
released in November 2007.
"Treating depression in adolescents can be particularly challenging
because few antidepressants have demonstrated efficacy in clinical trials
in this population," said Graham Emslie, MD, Professor of Psychiatry at the
University of Texas Southwestern Medical Center in Dallas. "In this study,
Lexapro significantly improved depressive symptoms in adolescents with MDD,
and was also well tolerated by study participants."
Researchers estimate that up to eight percent of adolescents are
affected by depression. Depression is a chronic disease that requires
medical treatment. However, FDA-approved treatment options for this
population are limited. Lexapro is not currently approved by the FDA for
use in pediatric or adolescent patients.
Based on the results of this study, Forest plans to file for an
adolescent depression indication for Lexapro this year.
Study Results
A double-blind, parallel-group, placebo-controlled phase III study to
evaluate the safety and efficacy of Lexapro in the treatment of depressed
adolescents, aged 12-17, was conducted in multiple centers across the U.S.
A total of 316 patients entered the eight week study, receiving either
Lexapro 10-20 mg (n=158) or placebo (n=158). The primary endpoint was
change from baseline to Week 8 on the Children’s Depression Rating Scale -
Revised (CDRS-R) using last observation carried forward (LOCF) approach.
The CDRS-R is a commonly used clinician-rated instrument that covers 17
symptom areas of depression relevant to adolescents, including impaired
schoolwork, difficulty having fun, social withdrawal, physical complaints,
and low self-esteem. The study showed statistically significant improvement
in patients treated with Lexapro relative to placebo based on the change
from baseline in the Buy generic amoxil CDRS-R score (-22.1 for Lexapro vs. -18.8 for placebo
treatment; p=0.022).
The trial also showed that Lexapro was generally well-tolerated.
Discontinuation rates due to adverse events were 2.6 percent and 0.6
percent for
patients receiving Lexapro and placebo, respectively. Serious
adverse events were reported by 2.6 percent of patients receiving Lexapro
and 1.3 percent for patients receiving placebo. The most commonly reported
adverse events (greater than 10 percent in either group) were headache (25
percent in Lexapro patients vs. 26 percent with placebo), menstrual cramps
(11 percent vs. 15 percent placebo), nausea (10 percent vs. 8 percent
placebo), insomnia (10 percent vs. 6 percent placebo) and inflicted injury
(9 percent vs. 13 percent placebo), the majority of which were accidental
in nature. The only adverse event occurring at a frequency of greater than
or equal to 5 percent and with an incidence for Lexapro treated patients
twice that of placebo treated patients was influenza-like symptoms (7
percent vs. 3 percent placebo).
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss
of interest in usual activities. While the brain chemistry of depression is
not fully understood, research suggests that depression is caused by an
imbalance of certain chemicals in the brain, most notably serotonin.
Despite advances and progress in identifying and treating mental
disorders in adolescents, depression in this population remains
under-treated. Depression is a chronic disease that requires medical
attention and treatment, and if left untreated, may have serious
consequences. According to the National Alliance on Mental Illness (NAMI),
adolescents with untreated depression are likely to have ongoing problems
in school, at home and with their friends.
For adolescents who suffer from depression, psychotherapy,
cognitive-behavior therapy, interpersonal therapy and medication play an
important role in the management of their illness. Patients on
antidepressant treatment should also be closely monitored by healthcare
providers, family members and other caregivers.
About Lexapro
Lexapro is an SSRI being studied as a treatment for adolescents with
MDD. Lexapro is indicated for the initial and maintenance treatment of
major depressive disorder and generalized anxiety disorder (GAD) in adults.
Lexapro is thought to work by helping to restore the brain’s chemical
balance. It is believed to increase the availability of serotonin, a
substance in the brain believed to influence mood. In adults, Lexapro 10
mg/day is a well-tolerated therapy, with drop-out rates due to adverse
events comparable to placebo treatment in depression trials. Lexapro has
been prescribed to over 16 million people.
Important Lexapro Information
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Antidepressants increased
the risk of suicidality (suicidal thinking and behavior) in children,
adolescents, and young adults in short-term studies of major depressive
disorder (MDD) and other psychiatric disorders. Anyone considering the use
of antidepressants in children, adolescents or young adults must balance
the risk to clinical need. Patients of all ages started on antidepressant
therapy should be closely monitored and observed for clinical worsening,
suicidality or unusual changes in behavior, especially at the beginning of
therapy or at the time of dose changes. This risk may persist until
significant remission occurs. Families and caregivers should be advised of
the need for close observation and communication with the prescriber.
Lexapro is not approved for use in pediatric patients.
Lexapro is contraindicated in patients taking monoamine oxidase
inhibitors (MAOIs), pimozide (see DRUG INTERACTIONS - Pimozide and Celexa),
or in patients with hypersensitivity to escitalopram oxalate. As with other
SSRIs, caution is indicated in the coadministration of tricyclic
antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro)
and other psychotropic drugs that interfere with serotonin reuptake may
increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs,
warfarin and other anticoagulants may add to the risk. Patients should be
cautioned about these risks. SSRIs and SNRIs have been associated with
clinically significant hyponatremia. Elderly patients or patients taking
antidiuretics or who are otherwise volume-depleted appear to be at a
greater risk. Discontinuation of Lexapro should be considered in patients
with symptomatic hyponatremia and appropriate medical intervention should
be instituted. The most common adverse events with Lexapro versus placebo
(approximately 5 percent or greater and approximately twice that of
placebo) were nausea, insomnia, ejaculation disorder, somnolence, increased
sweating, fatigue, decreased libido, and anorgasmia. Further information on
Lexapro is provided in the FDA approved Package Insert.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people’s lives. Forest Laboratories’ growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of
moderate
to severe Alzheimer’s disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation; and Bystolic(TM) (nebivolol), a
beta-adrenergic receptor blocking agent indicated for the treatment of
hypertension. In addition to our growing product line, Forest also
co-promotes the Daiichi Sankyo, Inc. product Azor(TM) (amlodipine and
olmesartan medoxomil), a calcium channel blocker and angiotensin receptor
blocker combination product indicated for the treatment of hypertension.
For more information, visit
Azor is a trademark of Daiichi Sankyo, Inc. and Campral is a
registered trademark of Merck Sante s.a.s., a subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.

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Auriga Laboratories Announces The Launch Of Extendryl(R) PEM And Extendryl(R) GCP

Monday, July 7th, 2008

Auriga Laboratories, Inc. (OTCBB: ARGA), a specialty pharmaceutical company, announced today the launch of Extendryl® PEM and Extendryl® GCP. The two new products will be marketed under the Extendryl brand name which consists of prescription products to treat various cough, cold, and allergy symptoms.
The prescription respiratory market is valued at more than 8 billion dollars in sales and more than 68 million prescriptions are written annually in the US. Extendryl® PEM (phenylephrine HCl 30 mg; methscopolamine nitrate 1.25 mg) Tablets combine two compounds; a decongestant with an anticholinergic/drying agent in an extended release format to provide 8 to 12 hours of relief of symptoms for adults suffering from nasal congestion and mucosal drainage associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma. Extendryl® GCP Oral Solution combines three compounds (100 mg/5 mL guaifenesin; 15 mg/5mL carbetapentane citrate; 5 mg/mL hydrochloride), and is indicated for temporary relief of non-productive cough accompanying respiratory tract congestion associated with the common cold, influenza, sinusitis, and bronchitis.
Extendryl® PEM and Extendryl®GCP will be launched in March 2008. "These new products further solidify Auriga’s commitment to enhance the Extendryl product line, and the launch is well timed to coincide with the start of Spring allergy season. These new additions to the Extendryl family will be a highly synergistic addition to Auriga’s current promotional efforts," said Frank Greico, Chief Executive Officer of Auriga.
Extendryl is contraindicated in patients who are sensitive to any of the ingredients or related compounds, and in patients with glaucoma, hypertension, cardiac disease, hyperthyroidism, urinary retention, peptic ulcer, patients on MAO inhibitor therapy and during an asthmatic attack. Extendryl GCP is contraindicated in women who are pregnant and/or nursing. Extendryl PEM is contraindicated in children under 6 years of age. Buy generic amoxil See individual product package inserts for full prescribing information.
About Auriga Laboratories™
Auriga Laboratories is a specialty pharmaceutical company building an extensive product portfolio of prescription brands targeting high growth therapeutic categories in the respiratory, dermatology, and psychiatry markets, which have combined annual revenues of more than fifteen billion dollars in the United States. The company’s high-growth business model combines driving revenues through a primarily variable cost commission-based sales structure, acquisition of proven brand names, introduction of new brands, and a strategic development pipeline, all of which designed to enhance its growing direct relationships with physicians nationwide. Auriga’s exclusive prescription and over-the-counter product portfolio includes Aquoral™ for the treatment of Xerostomia, Akurza™, Xyralid™, Zytopic™, and Coraz™ dermatology products, and the Zinx™ Extendryl ®, and Levall ® Families of products for relief of symptoms associated with a range of acute respiratory diseases. For more information, visit
Forward-Looking Statements
The information contained herein includes forward-looking statements. These statements relate to future events or to the company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to its operations, results of operations, growth strategy and liquidity.
The company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Statements regarding the company’s ability to increase its sales force and the success of such sales force in selling its products in light of competitive and other factors, the regulatory status and/or regulatory compliance of its products, the development of additional products, its ability to sustain market acceptance for its products, its dependence on collaborators, the company’s exposure to product liability claims, and the company’s prices, future revenues and income and cash flows and other statements that are not historical facts contain predictions, estimates and other forward-looking statements. Although the company believes that its expectations are based on reasonable assumptions, it can give no assurance that its goals will be achieved and these statements will prove to be accurate. Important factors could cause actual results to differ materially from those included in the forward-looking statements.
Auriga Laboratories
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Low-Level Stress Reduced By Nature, Not Technology

Monday, July 7th, 2008

Technology can send a man to the moon, help unlock the secrets of DNA and let people around the world easily communicate through the Internet. But can it substitute for nature?
Apparently not, according to a new study that measured individuals’ heart recovery rate from minor stress when exposed to a natural scene through a window, the same scene shown on a high-definition plasma screen, or a blank wall. The heart rate of people who looked at the scene through the window dropped more quickly than the others. In fact, the high-definition plasma screen had no more effect than the blank wall.
In addition, the research done through the Human Interaction with Nature and Technological Systems Lab at the University of Washington showed that when people spent more time looking at the natural scene their heart rates tended to decrease more. That was not the case with the plasma screen.
The study, funded by the National Science Foundation, is published in the current issue of the Journal of Environmental Psychology.
"Technology is good and it can help our lives, but let’s not be fooled into thinking we can live without nature," said Peter Kahn, a UW associate professor of psychology who led the research team.
"We are losing direct experiences with nature. Instead, more and more we’re experiencing nature represented technologically through television and other media. Children grow up watching Discovery Channel and Animal Planet. That’s probably better than nothing. But as a species we need interaction with actual nature for our physical and psychological well-being."
Part of this loss comes from what the researchers call environmental generational amnesia. This is the idea that across generations the amount of environmental degradation increases, but each generation views conditions it grew up with as largely non-degraded and normal. Children growing up today in the cities with the worst air pollution often, for example, don’t believe that their communities are particularly polluted.
"This problem of environmental generational amnesia is particularly important for children coming of age with current technologies," said Rachel Severson, a co-author of the study and a UW psychology doctoral student. "Children may not realize they are not getting the benefits of actual nature when interacting with what we’re calling technological nature."
To see how people reacted to nature and a technological representation of it, the researchers recruited 90 college students to participate in an experiment that had them work on four mental tasks while sitting at a desk in an office. With 30 of the students, the desk faced a window overlooking a campus scene that included a large fountain and trees. For a second group of 30 students, the window was replaced with the plasma screen that showed the same nature scene in real time. For the remaining 30 students, curtains covered the plasma screen and the desk faced a blank wall.
Participants were tested individually. Each was welcomed by a researcher, hooked up to a heart rate monitor and told to wait for five minutes while the researcher stepped out of sight. A camera mounted on the wall near the window or plasma screen was synchronized with the heart monitor and tracked participants’ eye movements. At the end of the waiting period, the researcher returned, explained the first task and stepped out of sight. This was repeated for the remaining three tasks and then the subject was told to wait again for five minutes.
generic cialis online buy Heart recovery rate was based on how quickly each participant’s heart rate dropped in the 60 seconds after being told to wait or to have one of the tasks explained. Each person’s performance was tallied on the basis of six measurements, once after every task and the two waiting periods. Low-level stress was created by having to deal with another person in a social situation and the anticipation or performance anxiety each might have experienced to do well on the four tasks.
The researchers found that participants with the plasma screen actually looked at it just as often as did those who had the window. However, the window held the students’ attention significantly longer than the plasma screen did. When participants spent more time looking at the window, their heart rates decreased faster than on tasks when they spent less time looking at the window. This was not true with the plasma screen.
"I was surprised by this," said Kahn. "I thought the plasma screen would come somewhere between the glass window and the blank wall. This study is important because it shows the importance of nature in human lives and at least one limitation of technological nature.
"In the years ahead, technological nature will get more sophisticated and compelling. But if it continues to replace our interaction with actual nature, it will come at a cost. To thrive as a species, we still need to interact with nature by encountering an animal in the wild, walking along the ocean’s edge or sleeping under the enormity of the night sky."
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Co-authors of the study are Batya Friedman, Jennifer Hagman, Erika Feldman and Anna Stolyar of the UW, Brian Gill of Seattle Pacific University, Nathan Freier of Rensselaer Polytechnic Institute and Sybil Carr??»re of California State University, San Bernardino. Freier and Carr??»re were both at the UW when they worked on the study.
More information about the Human Interactions with Nature and Technological Systems Lab is available at
Source: Joel Schwarz
University of Washington
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