In the May issue of the Journal of Attention Disorders, the researchers argue schools and communities should do a better job of getting information to minority families about the combined benefit of medication and counseling for attention deficit hyperactivity disorder.

“ADHD has multiple causes and multiple treatment approaches are warranted,” said John Carlson, associate professor of school psychology. Carlson co-authored the study with Andy Pham, a recent Ph.D. graduate, and John Kosciulek, professor of rehabilitation counseling.

More than 4.5 million children have been diagnosed with ADHD in the United States, making it one of the most common childhood disorders, according to the Centers for Disease Control and Prevention.

The disorder, characterized by impulsive behavior and inattentiveness, often lasts into adulthood. Causes include both biological and environmental factors, the study said.

Medication such as Ritalin has shown to decrease hyperactivity in children with ADHD, while counseling such as behavior therapy and parent training can lead to improved relationships with family and friends, Carlson said. The treatments can be successfully combined to treat severe behavioral problems, he said.

But according to study, which included a scientific survey of parents, blacks and Latinos are less likely than whites to consider combining medication and counseling for their children. The barriers preventing minorities from seeking and using these treatments include a lack of culturally competent health-care providers, financial hurdles and little dissemination of information about treatments that work.

Pham said the “significant increase in children diagnosed with ADHD” intensifies the need for parents to be informed of all treatment options.

“Parents may bring different cultural beliefs to the treatment context,” Pham said. “Therefore practitioners such as physicians and school psychologists must build on their own cultural knowledge when working with families to determine the best course of action.”

Source:
John Carlson
Michigan State University

View drug information on Ritalin LA.

Swedish experts teamed up to carry out what they believe is the first study of risk factors for ADHD in a national cohort of school children, based on 1.16 million children on the country’s Prescribed Drug Register.

“We identified 7,960 Swedish-born children, aged between six and 19, using a prescription for ADHD medication as our indicator of severe ADHD” explains lead author Professor Anders Hjern from the Centre for Health Equity Studies, a collaboration between the Karolinska Institutet and Stockholm University.

“We then tracked their records through other registers, using the unique ten digit reference number all Swedish residents are given at birth, to determine a number of other factors.”

ADHD is a common, treatable childhood illness that can affect areas of the brain connected to problem solving, planning ahead, understanding others’ actions and controlling impulses. The primary symptoms of the condition are hyperactivity, impulsivity and inattention.

“Genes are also known to play an important role in the development of ADHD and studies of identical twins show that they are very likely to exhibit the same ADHD traits” says Professor Hjern, who carried out the study when he was based at the National Board of Health and Welfare.

Key findings of the Swedish study include:

Boys were three times more likely to be on ADHD medication than girls, with medication use highest in boys aged between 10 and 15.

Women who had only received the most basic education were 130 per cent more likely to have a child on ADHD medication than women with university degrees.

Children were 54 per cent more likely to be on ADHD medication if they came from a single parent family rather than having both parents at home.

Coming from a family on welfare benefits increased the risk of ADHD medication by 135 per cent when compared with households not claiming benefits.

There were no statistically significant differences between the effects that socioeconomic factors had on boys or girls in the study.

When the researchers examined the total impact of the socioeconomic factors, they found that the impact was similar to that reported in twin studies.

“Our study showed that almost half of the cases could be explained by the socioeconomic factors included in our analysis, clearly demonstrating that these are potent predictors of ADHD-medication in Swedish schoolchildren” says Professor Hjern.

“There are several ways that family factors may influence ADHD. For example, low parental education is associated with general social disadvantage, a higher number of stress factors and a greater risk of childhood adversity.

“Lack of time and money are more common in single parent families, as are lack of social support and family conflict, including separation, divorce and parental absence.

“We believe that further research into ADHD should focus on the interaction between genes and environmental factors in order to determine the reasons why some children develop ADHD and how it could be prevented.”

Notes:
Social adversity predicts ADHD-medication in school children - a national cohort study. Hjern et al. Acta Paediatrica. 99, pp920-924. (June 2010). DOI: 10.1111/j.1651-2227.2009.01638.x

Source:
Annette Whibley
Wiley-Blackwell

The research, which included both elementary school-age and college-age participants, found that children who exceeded the two hours per day of screen time recommended by the American Academy of Pediatrics were 1.5 to 2 times more likely to be above average in attention problems.

“There isn’t an exact number of hours when screen time contributes to attention problems, but the AAP recommendation of no more than two hours a day provides a good reference point,” said Edward Swing, an Iowa State psychology doctoral candidate and lead researcher in the study. “Most children are way above that. In our sample, children’s total average time with television and video games is 4.26 hours per day, which is actually low compared to the national average.”

Collaborating with Swing on the research were ISU’s Douglas Gentile, an associate professor of psychology and Craig Anderson, a Distinguished Professor of psychology; and David Walsh, a Minneapolis psychologist. Their study will be published in the August print issue of Pediatrics — the journal of the American Academy of Pediatrics — available online.

Studies on elementary, college-aged youths

The researchers assessed 1,323 children in third, fourth and fifth grades over 13 months, using reports from the parents and children about their video game and television habits, as well as teacher reports of attention problems. Another group of 210 college students provided self-reports of television habits, video game exposure and attention problems.

Previous research had associated television viewing with attention problems in children. The new study also found similar effects from the amount of time spent with video games.

“It is still not clear why screen media may increase attention problems, but many researchers speculate that it may be due to rapid-pacing, or the natural attention grabbing aspects that television and video games use,” Swing said.

Gentile reports that the pace of television programming has been quickened by “the MTV effect.”

“When MTV came on, it started showing music videos that had very quick edits — cuts once every second or two,” Gentile said. “Consequently, the pacing of other television and films sped up too, with much quicker edits.”

He says that quicker pace may have some brain-changing effects when it comes to attention span.

“Brain science demonstrates that the brain becomes what the brain does,” Gentile said. “If we train the brain to require constant stimulation and constant flickering lights, changes in sound and camera angle, or immediate feedback, such as video games can provide, then when the child lands in the classroom where the teacher doesn’t have a million-dollar-per-episode budget, it may be hard to get children to sustain their attention.”

The study showed that the effect was similar in magnitude between video games and TV viewing. TV, video games may contribute to ADHD

Based on the study’s findings, Swing and Gentile conclude that TV and video game viewing may be one contributing factor for attention deficit hyperactivity disorder (ADHD) in children.

“ADHD is a medical condition, but it’s a brain condition,” Gentile said. “We know that the brain adapts and changes based on the environmental stimuli to which it is exposed repeatedly. Therefore, it is not unreasonable to believe that environmental stimuli can increase the risk for a medical condition like ADHD in the same way that environmental stimuli, like cigarettes, can increase the risk for cancer.”

“Although we did not specifically study the medical condition of ADHD in these studies, we did focus on the kinds of attention problems that are experienced by students with ADHD,” added Swing. “We were surprised, for example, that attention problems in the classroom would increase in just one year for those children with the highest screen time.”

Swing points out that the associations between attention problems and TV and video game exposure are significant, but small.

“It is important to note that television or video game time cannot solely explain the development of attention problems,” he said. “Clearly other factors are involved.”

The researchers plan to continue studying the effects of screen time on attention. They also hope future research can identify what aspects of television or video games may be most relevant to attention problems.

Source:
Mike Ferlazzo
Iowa State University

The study also examined the effects of substance use and abuse on high school graduation and found that among students who engage in substance use, including alcohol and other drugs, teens who smoke cigarettes are at greatest risk of dropping out.

There are three types of ADHD: the hyperactive type, the inattentive type and the combined type. Symptoms include not being able to pay attention, daydreaming, being easily distracted and being in constant motion or unable to remain seated.

“Most people think that the student who is acting out, who is lying and stealing, is most likely to drop out of school. But we found that students with the combined type of ADHD - the most common type - have a higher likelihood of dropping out than students with disciplinary problems,” said Julie Schweitzer, an expert on ADHD at the UC Davis MIND Institute, an associate professor of psychiatry and behavioral sciences and the study’s senior author. “This study shows that ADHD is a serious disorder that affects a child’s ability to be successful in school and subsequently in a way that can limit success in life.”

Published online in July in the Journal of Psychiatric Research, the study “Childhood and Adolescent-onset Psychiatric Disorders, Substance Use, and Failure to Graduate High School on Time” found that 32.3 percent of students with the combined type of ADHD - which incorporates hyperactive and inattentive symptoms - drop out of high school. Fifteen percent of teens with no psychiatric disorder drop out.

“Understanding the factors that contribute to dropping out of high school has major public-health implications, given that a third of youth in this country do not complete high school on time. Supporting mental-health interventions for students may have a significant impact on reducing high school dropout,” said study author Elizabeth Miller, an assistant professor of pediatrics and an adolescent medicine specialist at UC Davis Children’s Hospital.

In 2006 an estimated 4.5 million children in the United States between 5 and 17 years of age were diagnosed with attention-deficit/hyperactivity disorder, according to the Centers for Disease Control and Prevention. An estimated 9.5 percent of boys and 5.9 percent of girls are diagnosed with the condition.

The next most at-risk teens are students with conduct disorder, whose symptoms include aggression, lying, stealing, truancy, vandalism and a general pattern of rule-breaking. Thirty-one percent of students with conduct disorder drop out, said Joshua Breslau, associate professor of internal medicine and the study’s lead author. Breslau said the research shows there are different pathways to poor high school performance.

“This study identifies multiple ways in which mental-health problems can affect education at the high school level. Attention-deficit/hyperactivity disorder impacts achievement because it affects how well students are able to perform basic classroom tasks from paying attention to turning in their homework,” said Breslau. “Students with conduct disorder are able to do just as well as everyone else academically but disciplinary issues and dealing with the routines of school life may cause them to drop out.”

For the study, the researchers examined the joint, predictive effects of childhood- and adolescent-onset psychiatric and substance-use disorders on failure to graduate high school on time, using data collected during 2001 and 2002 from the National Epidemiological Survey of Alcohol and Related Conditions. A total of approximately 43,000 racially diverse male and female participants over 18 from throughout the United States were interviewed by U.S. Census Bureau representatives about the age of onset of psychiatric diagnoses, substance use and high school graduation. Respondents were excluded if they had less than eight years of education or arrived in the U.S. after age 13. A total of 29,662 of the respondents were included in the UC Davis study.

Among childhood and adolescent psychiatric disorders, diagnosis with either the combined type of ADHD or the inattentive type - at 28.6 percent - resulted in the highest dropout rates. Students with mania, a mood disorder, and panic disorder dropped out at 26.6 and 24.9 percent respectively. Students with other mental-health disorders had dropout rates in the high teen- to low 20-percent range. The disorders included specific phobias (like fear of water), social phobia (fear of people), post-traumatic stress disorder, generalized anxiety disorder and depression.

But more predictive of dropping out than all other mental-health disorders except ADHD and conduct disorder was tobacco use. The study found that 29 percent of students who used tobacco failed to complete high school on time. Only 20 percent of teens who used alcohol and 24.6 percent of teens who used drugs dropped out. However, when the three substances were examined together, the effect of drinking and using drugs was no longer significant, Breslau said.

“Kids who smoke had a much higher risk of dropping out than kids who drink alcohol or use other drugs. When we looked at smoking in combination with other substances, drinking and using drugs did not increase one’s risk of not completing high school on time. There’s no additional increment of risk of dropping out once you account for smoking,” Breslau said.

The reasons why this is the case merits further investigation, he said. However, existing literature suggests that poor educational performance contributes to smoking. If this is true, then breaking the connection between smoking and education may be essential to further reduction in the prevalence of smoking, Breslau said.

The implication of the findings, according to Breslau, is that the impact of mental health on education is likely to arise from a small set of conditions.

“This study suggests that focusing on a relatively narrow and hopefully more manageable range of mental-health conditions may have a consequential impact on improving school performance in secondary education.”

Schweitzer said that devising effective interventions to help students with ADHD graduate high school would have important long-term societal consequences.

“If you don’t have your high school degree, you’re going to have less income. You can’t buy houses and cars. People who drop out of high school are more likely to be reliant on public assistance. This is a disorder that has serious long-term impacts on your ability to be successful and contribute to society, not just in school, but for the rest of your life,” she said.

Source: University of California - Davis - Health System

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

The research findings have just been published online in the international Journal of Attention Disorders.

Leader of Nutrition studies at the Institute, Associate Professor Wendy Oddy, said the study examined the dietary patterns of 1800 adolescents from the long-term Raine Study and classified diets into ‘Healthy’ or ‘Western’ patterns.

“We found a diet high in the Western pattern of foods was associated with more than double the risk of having an ADHD diagnosis compared with a diet low in the Western pattern, after adjusting for numerous other social and family influences,” Dr Oddy said.

“We looked at the dietary patterns amongst the adolescents and compared the diet information against whether or not the adolescent had received a diagnosis of ADHD by the age of 14 years. In our study, 115 adolescents had been diagnosed with ADHD, 91 boys and 24 girls.”

A “healthy” pattern is a diet high in fresh fruit and vegetables, whole grains and fish. It tends to be higher in omega-3 fatty acids, folate and fibre. A “Western” pattern is a diet with a trend towards takeaway foods, confectionary, processed, fried and refined foods. These diets tend to be higher in total fat, saturated fat, refined sugar and sodium.

“When we looked at specific foods, having an ADHD diagnosis was associated with a diet high in takeaway foods, processed meats, red meat, high fat dairy products and confectionary,” Dr Oddy said.

“We suggest that a Western dietary pattern may indicate the adolescent has a less optimal fatty acid profile, whereas a diet higher in omega-3 fatty acids is thought to hold benefits for mental health and optimal brain function.

“It also may be that the Western dietary pattern doesn’t provide enough essential micronutrients that are needed for brain function, particularly attention and concentration, or that a Western diet might contain more colours, flavours and additives that have been linked to an increase in ADHD symptoms. It may also be that impulsivity, which is a characteristic of ADHD, leads to poor dietary choices such as quick snacks when hungry.”

Dr Oddy said that whilst this study suggests that diet may be implicated in ADHD, more research is needed to determine the nature of the relationship.

“This is a cross-sectional study so we cannot be sure whether a poor diet leads to ADHD or whether ADHD leads to poor dietary choices and cravings,” Dr Oddy said.

ADHD is the most commonly diagnosed childhood mental health disorder and has a prevalence of approximately 5%. ADHD is known to be more common in boys.

Source: Research Australia

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Five community groups are promoting female condoms through outreach initiatives, which are funded in part by a $500,000 grant from the MAC AIDS Fund. The groups plan to distribute 500,000 female condoms during instructional sessions held at beauty salons, barber shops, churches and restaurants. CVS also is selling female condoms at all D.C. drugstores.

City officials also have launched an ad campaign to promote female condom use, which will be featured on a website and posters on about one-third of the city’s buses. The ads are expected to run for about three months and again in the spring (Gresko, AP/Atlanta Journal-Constitution, 7/28).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families.

© 2010 National Partnership for Women & Families. All rights reserved.

Dr. Kemper is a leading international authority on complementary therapies for children. With up-to-date research, illustrative examples and a practical approach for individuals and families, Mental Health, Naturally provides a comprehensive overview of mental health disorders, outlines specific strategies for improving mental health, and offers detailed approaches for those suffering from ADHD, anxiety, stress and substance abuse.

Dr. Kemper also covers fundamental techniques used to combat mental health problems such as maintaining proper nutrition, rest and exercise, while detailing stress-management practices and methods such as acupuncture, homeopathy, massage and chiropractic and osteopathic therapies. Detailed chapters on dietary supplements, a chapter on advocacy, and a section with action plans and additional resources also are provided.

Mental Health, Naturally will be available in bookstores nationwide in March. The guide may also be ordered on the new AAP Web site for parents, HealthyChildren.org by going to http://www.healthychildren.org/mental-health-naturally. For interviews or review copies, please contact the AAP Department of Communications. Cover art is available.

About the author

Kathi J. Kemper, MD, MPH, FAAP, is recognized internationally as the leading authority on holistic, integrative and complementary therapies for children. She is the chairperson of the American Academy of Pediatrics Section on Complementary, Holistic, and Integrative Medicine. She is the Caryl J. Guth chair for holistic and integrative medicine at the Wake Forest University School of Medicine and the 2008 recipient of the inaugural Leadership Award from the Integrative Pediatrics Council. Dr. Kemper lives in Winston-Salem, North Carolina.

Source
American Academy of Pediatrics

“In our Phase 1 multiple rising dose study in healthy volunteers, TC-5619 showed beneficial effects on a surrogate measure of attention at doses in the range being studied in this Phase 2 trial, suggesting its promise as a treatment for ADHD,” said Geoffrey Dunbar, M.D., Senior Vice President, Clinical Development and Regulatory Affairs of Targacept. “The depth of our pipeline of product candidates being studied in ADHD places us at the forefront of development in this therapeutic area. The pharmacological diversity reflected by TC-5619, an alpha7 modulator, and AZD3480 and AZD1446, both alpha4beta2 modulators, underscore the potential that our NNR Therapeutics have to meet the needs of patients affected by this disorder.”

“Stimulants remain the most frequently prescribed therapy for ADHD. But prescriptions for stimulants must be scheduled due to their abuse potential, and they are often associated with serious side effects,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. “A new, well-tolerated, non-stimulant treatment option could potentially improve the lives of many of the estimated 23 million adults and 22 million children and adolescents with ADHD.”

The multi-center Phase 2 clinical proof of concept ADHD trial is a double-blind, placebo controlled, randomized, parallel group study being conducted in the United States. The trial is planned to enroll up to 125 patients ages 18 to 65. As with Targacept’s ongoing Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the trial design provides for patients to be randomly assigned to one of two cohorts, TC-5619 or placebo, and dosed over a 12-week period. Patients randomized to the TC-5619 arm will be up-titrated every four weeks and tested on each of three doses of TC-5619. The primary efficacy outcome measure of the trial is change from baseline on the Conners Adult ADHD Rating Scale, a multimodal questionnaire assessment of symptoms and behaviors associated with ADHD in adults aged 18 and older.

The ADHD trial is part of a recently expanded development program for TC-5619 that also includes Targacept’s ongoing Phase 2 clinical proof of concept trial in CDS and other studies planned to be conducted by each of Targacept and its strategic collaborator AstraZeneca to support the potential advancement of TC-5619 into Phase 2 clinical development for Alzheimer’s disease. AstraZeneca has the future right to license TC-5619 for various cognitive disorders under the parties’ December 2005 collaboration agreement.

About ADHD

Attention deficit/hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders. The principal characteristics of ADHD are inattention, hyperactivity and impulsivity. ADHD is a chronic disorder that develops during childhood, often persists into adulthood and can negatively impair many aspects of daily life, including home, school, work and interpersonal relationships. The market research firm Business Insights estimated that there were approximately 23.3 million adults and 21.6 million children and adolescents with ADHD in 2009 in the world’s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan).

About TC-5619

TC-5619 is a novel small molecule that is highly selective for the alpha7 NNR. The alpha7 NNR subtype has been shown to be a key regulator of cognitive function, including attention, memory and learning [1]. Preclinical studies of alpha7 modulators suggest cognition-enhancement in the central nervous system (CNS) [2]. As a result, alpha7 NNR-targeted therapies, used alone or in combination with other drugs, offer a potential new approach to treating the constellation of symptoms associated with CNS diseases and disorders. TC-5619 has little or no interaction with 5HT3 receptors or hERG channels, properties that distinguish it from other alpha7 NNR-targeted compounds and could facilitate a more favorable tolerability profile.

[1] Leiser, S.C., et al., A cog in cognition: How the alpha7 nicotinic acetylcholine receptor is geared towards improving cognitive deficits, Pharmacol Ther, (2009), doi: 10.1016/jpharmthera.2009.03.009.

[2] Hauser, T.A., et al., TC-5619: An alpha7 neuronal nicotinic receptor-selective agonist that demonstrates efficacy in animal models of the positive and negative symptoms and cognitive dysfunction of schizophrenia. Biochem. Pharmacology 2009; 78: 803-812.

Source
Targacept

The authors, Leslie Sherlin, PhD, Martijn Arns, MSc, Joel Lubar, PhD and Estate Sokhadze, PhD, reviewed over 40 studies which support the claim of level 5 efficacy and made recommendations for treatment and future study. These studies utilized different neurofeedback modalities and compared to different control groups, including medication. The neurofeedback modalities of theta/beta ratio and slow cortical potential training were represented most frequently. Most of these studies looked at impulse control, attention and hyperactivity measures. Impulse control and attention issues seem to be best remediated with neurofeedback training.

The International Society for Neurofeedback and Research (ISNR) is pleased with these findings and hopes that they help in further promoting the neurofeedback modality to the medical and psychological communities and also encourage third party payers to consider neurofeedback as a viable modality for reimbursement.

Neurofeedback uses monitoring devices to provide moment-to-moment brain wave information back to the client. This self-regulation modality is non-invasive and may be a good alternative to medication. Research demonstrates that neurofeedback is also an effective intervention for Epilepsy. Ongoing research is investigating the effectiveness of neurofeedback for other disorders such as Autism, headaches, insomnia, anxiety, substance abuse, TBI and other pain disorders, and is promising.

Source
International Society for Neurofeedback and Research

“The FDA approval of Daytrana for adolescents now extends this medication option to an additional group of ADHD patients who may benefit from ADHD treatment delivered by a patch,” said Mike Yasick, senior vice president of the Shire ADHD business unit. “This approval reinforces Shire’s commitment to providing a varied and comprehensive portfolio of medicines to meet the diverse needs of ADHD patients.”

The efficacy of Daytrana was demonstrated in a multi-center, 7-week, phase 3b, randomized, double-blind, placebo-controlled study in 217 adolescents aged 13 to 17 diagnosed with ADHD. The primary efficacy measure was the mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score. The Daytrana treatment group demonstrated significant reduction (indicating improvement) in ADHD-RS-IV total score from baseline to endpoint compared with placebo (P<.001). The most commonly reported adverse reactions associated with Daytrana (greater than or equal to 5% and twice the rate of placebo) in this study were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia (persistent loss of appetite). The majority of subjects in the study had erythema (redness or rash) at the application site.

Daytrana is a transdermal patch that is applied to intact skin and delivers methylphenidate through the skin into the bloodstream. It is recommended that Daytrana be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. The effects can continue for several hours after the patch is removed. With guidance from the prescribing physician, Daytrana can be removed earlier than 9 hours if a shorter duration of effect is desired and/or to help manage potential late-day side effects. This flexibility allows parents, working with physicians, to tailor the treatment to a patient’s specific needs and to accommodate changing schedules. Daytrana is available in patch strengths of 10 mg, 15 mg, 20 mg, and 30 mg (nominal dose delivered over a 9-hour wear time). The prescribing physician should titrate the dose of DAYTRANA to the desired effect.

Please see accompanying Full Prescribing Information, including Boxed Warning regarding potential for abuse and dependence.

Daytrana is licensed globally to Shire by Noven Pharmaceuticals, Inc.

Indication

Daytrana is indicated for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents aged 6 to 17 years. The efficacy of Daytrana was established in two controlled 7-week clinical trials in children and one controlled 7-week trial in adolescents.

Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

Important Safety Information

Daytrana should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Daytrana should not be used in patients who have an allergy to methylphenidate or other patch components; marked anxiety, tension, or agitation; glaucoma; tics or diagnosis of a family history of Tourette’s syndrome; seizures; are being treated (or within 14 days after treatment) with monoamine oxidase inhibitors (MAOIs).

Stimulant products generally should not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. A careful patient history, including family history, and physical exam should be taken to assess the presence of cardiac disease. Patients reporting symptoms of cardiac disease (ie, exertional chest pain, unexplained syncope) should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate. Use cautiously with pressor agents.

Use of Daytrana may lead to contact sensitization; Treatment should be discontinued if contact sensitization is suspected. Mild to moderate erythema has been commonly reported and is not by itself an indication of sensitization. Patients should avoid applying external heat to the Daytrana patch.

Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Hematologic monitoring is advised during prolonged treatment. New psychosis, mania, aggression, visual disturbances, and growth suppression, have been associated with the use of stimulants. Growth should be monitored in children during treatment with stimulants, and patients who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.

In addition to application site reactions, the most commonly reported adverse reactions associated with Daytrana (greater than or equal to 5% and twice the rate of placebo) in clinical trials were: children - decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability and anorexia; adolescents decreased appetite, nausea, insomnia, decreased weight, dizziness, abdominal pain and anorexia. Leaving the patch on for greater than the recommended 9 hours could lead to a higher incidence of adverse events.

About ADHD

ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC).

ADHD is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific etiology of ADHD is unknown and there is no single diagnostic test for this disorder. Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV®) or International Classification of Diseases 10 (ICD-10).

Although there is no cure for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological or behavioral modification, and/or medication.

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

Source: Shire plc