Qualitest Pharmaceuticals today issued a voluntary nationwide  retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen  Tablets, USP 7.5mg/500mg. This recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen  Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B.  Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.

Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (acetaminophen is in both preparations.) Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction.  Side effects due to caffeine are less likely, due to the small amounts in this formulation; however, those individuals with sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution.  No injuries have been reported to date.

The recall includes the following products:

• Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).  Lot numbers can be found on the side of the manufacturer’s bottle.  Butalbital, Acetaminophen, and Caffeine Tablets are (approximately 11.0 mm in diameter), white round-shaped tablets, debossed (2544) on one side, and debossed (V) on the reverse side; Hydrocodone Bitartrate and Acetaminophen Tablets are  (approximately 16.5  mm in length), white with green specs, round, capsule shaped, scored tablets, debossed (3594) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets.

Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.

Consumers and patients with questions may contact Qualitest at 1-800-444-4011 for more information, Monday through Friday between the hours of 8AM and 5PM CST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Reports of adverse reactions or quality problems can also be reported to Qualitest at

1-800-444-4011; Monday through Friday between the hours of 8AM and 5PM CST.

The American Academy of Nurse Practitioners (AANP) today announced it has joined a growing collaboration of professional organizations in the program, “HAE: Learn About It, Talk About It.”  This peer-to-peer clinician education program facilitates education and dialogue among several disciplines and specialties that see patients with hereditary angioedema (HAE), a rare, and potentially fatal swelling disorder, to improve accurate diagnosis and appropriate management of the disease.

“The rate of misdiagnosis and delayed diagnosis for HAE is still alarmingly high, and the AANP is proud to bring this program to our members during the 26th Annual Conference to provide the education that may help improve care for HAE patients,” said Mary Jo Goolsby, EdD, MSN, NP-C, CAE, FAANP, Director of Research & Education at AANP.  ”The launch of our partnership this week highlights the importance of HAE, in recognition of the critical role NPs can play in improving time to diagnosis and appropriate management and demonstrating our commitment to working with other specialties to improve care for patients.”

HAE affects about at least 6,000 people in the United States and is characterized by recurrent, unpredictable, debilitating, and potentially life-threatening attacks of swelling that can occur almost anywhere in the body, including the larynx, abdomen, face, extremities and urogenital tract.   About 68 percent of people with HAE are initially misdiagnosed, and for some patients, it has taken up to 20 years to receive an accurate diagnosis.  Patients with HAE can experience up to 100 days of incapacitation per year, which can make it difficult to hold down a job, excel in school, or participate in daily activities, and about a third of patients have undergone unnecessary surgery.

“As a nurse practitioner in an allergy specialty practice, I know that rare diseases like hereditary angioedema may be overlooked when evaluating the causes and clinical presentation of swelling symptoms.  It’s important for clinicians to know that HAE attacks do not respond to drugs used to treat other forms of urticaria and swelling such as antihistamines, epinephrine and corticosteroids, and if left untreated, the disease can be fatal,” said Kathryn Blair, PhD, FNP-BC, AANP program advisor, nurse Practitioner at the Williams Storms Allergy Clinic Colorado Springs Colorado and Professor and option NP coordinator at the University of Colorado- Colorado Springs.  ”An accurate and timely diagnosis is more important than ever because it can put patients on the path to appropriate management faster.”

“HAE: Learn About It, Talk About It,” which launched in May 2010 as a joint effort of the American College of Allergy, Asthma and Immunology (ACAAI) and the American Gastroenterological Association (AGA) Institute, has since grown into a collaboration amongst the ACAAI, the AGA, the World Allergy Organization (WAO), the American College of Emergency Physicians (ACEP), the American Academy of Nurse Practitioners (AANP), and the Society of Emergency Medicine Physician Assistants (SEMPA).  The program is supported by ViroPharma Incorporated.

Nurse practitioners can learn more about HAE at booth 3117 at the American Academy of Nurse Practitioners 26th Annual Conference in Las Vegas, NV, June 21-26.

About HAE: Learn About It, Talk About It

“HAE: Learn About It, Talk About It” is a clinician education program aimed at uniting disparate specialties that see patients with HAE to improve patient care through increased awareness and education, more timely diagnosis, and appropriate disease management.   The core component of this program is an informational and interactive Website – www. LetsTalkHAE.com – which provides health care providers with the tools they need to more readily diagnose symptoms and properly manage HAE.

The Website features targeted content for various specialties that may see patients presenting with HAE symptoms, as well as several educational resources, including a podcast series, iPhone application, archived Webinar, videos from HAE-treating clinicians and case studies.  LetsTalkHAE.com also features a tool where clinicians can find a local HAE-treating allergist/immunologist or can register as an HAE-treating allergist/immunologist.  For more information, visit www.LetsTalkHAE.com.

According to a national survey of more than 38,000 families, 8 percent of children in the United States suffer from a food allergy –  a considerably higher number than reported in previous studies.  In addition to estimating that 5.9 million children under age 18 now have a food allergy, the new study, published in the July issue of Pediatrics, the journal of the American Academy of Pediatrics, found that nearly 39 percent of the youngsters surveyed had a severe or life-threatening allergy, and that more than 30 percent had multiple food allergies.  Consistent with previous research, the study, funded by the Food Allergy Initiative (FAI), reported that children with a tree nut or peanut allergy tend to have the most severe reactions.

“This is the largest study ever conducted on the prevalence of food allergy in U.S. children and it differs from previous studies in important ways,” said the principal investigator, Ruchi S. Gupta, M.D., MPH, a pediatrician at Children’s Memorial Hospital and assistant professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “Our goal was to paint a comprehensive picture of childhood food allergy in America.  We began by surveying a representative sample of children in the U.S. and collected extensive information on each and every food allergy reported – including date of onset, method of diagnosis, and reaction history.”  Data on race and ethnicity, gender, socioeconomic status, and geographic region were also collected.

“This study confirms what so many families already know: food allergy is a large and growing public health problem,” said Mary Jane Marchisotto, executive director, FAI. “In 2008, the Centers for Disease Control estimated that food allergies affected 1 in 25 children; now it’s 1 in 13.  That translates into 2 children in every classroom.  It is especially disturbing to see how many of these children have multiple food allergies and have already experienced life-threatening reactions.  From previous research, we know that food-allergic reactions send an adult or child to the emergency room every three minutes—every six minutes for potentially fatal reactions.  Every day, we hear from families who are struggling with the emotional,  physical, and economic impact of food allergies.  That’s why FAI is committed to accelerating the pace of clinical trials that will lead to new therapies and, ultimately, a cure.”

For more information, please visit www.faiusa.org/PrevalenceStudy2011.

About Food Allergies
Food allergies affect approximately 12 million Americans.  Eight foods are responsible for 90 percent of all reactions:  peanut, tree nut, milk, egg, fish, shellfish, soy, and wheat.  Although food allergies appear to be on the rise in developed countries worldwide, researchers do not yet know the reason why.  One common theory is the hygiene hypothesis, which posits that excessive hygiene is responsible for the increase of allergies and other immune-mediated diseases.  The theory suggests that since we are no longer exposed to many bacteria, viruses and parasites, our immune system targets harmless substances, such as food proteins, instead.  There is no cure for food allergies, and no medication can prevent anaphylaxis, a potentially life-threatening reaction.  Strict avoidance of problem foods remains the only way to prevent a reaction.

SOURCE Food Allergy Initiative

Phadia, the worldwide leader of in vitro allergy diagnostics, is pleased to contribute to the largest cross-sectional allergy study ever conducted through the use of its ImmunoCAP(R) Specific IgE blood test, the market leading in vitro allergy diagnostic test.

The landmark study by Quest Diagnostics, the world’s leading provider of diagnostic testing, information, and services, includes test results from over 2 million patients. The Health Trends Report(TM) confirms the “allergy march” in which early childhood food allergies heighten the risk for development of additional and more severe allergy-related conditions, including asthma, later in life. In addition, the report shows that patients with asthma are 20% more likely to have an allergic component to their condition. This confirms that allergy testing and exposure reduction to a patient’s specific allergic triggers are critically important steps to take for patients with asthma.

The study found that about half of patients tested (5 in 9) did not show sensitization to at least one of 11 common allergens evaluated. While the investigators hypothesize that some of these patients had an allergy to an allergen not evaluated in the study, they also theorize that a large number may have presented to their physician with allergy-like symptoms caused by a non-allergy medical condition. The importance of identifying and ruling out an allergy is important in order to improve quality of life for many patients.

David Esposito, President and General Manager of Phadia US, says, “We commend Quest Diagnostics on their leadership role in spotlighting the impact of allergies in our nation. This data enables us to work together to support health care reform initiatives that call for better patient care at reduced costs. With full knowledge of their allergies and armed with an allergy or asthma action plan, patients can reduce unscheduled doctors’ office and emergency room visits, lessen the need for medications including costly inhaled corticosteroid/long-acting beta agonist combination medications, and minimize sick days that cause missed school or work. Our hope is that this data is used by payers and policy makers to support and embrace the NIH Guidelines that recommend allergy testing for all patients with persistent asthma.”

The study was based on 14 million de-identified test results. Each test result identified sensitization to one or more of 11 common allergens: five foods (egg white, milk, peanut, soybean and wheat), common ragweed, mold and two types of house dust mites as well as cats and dogs.

Phadia will utilize data from the Quest Health Trends Report to expand and extend the use of the ImmunoCAP Specific IgE blood test to support a guidelines-based approach to diagnosing and managing allergic diseases. Phadia and Quest Diagnostics have partnered to improve the diagnosis and assessment of allergic disease for over two decades.

The full Allergies Across America Health Trends Report by Quest Diagnostics was recently released. For more information please visit: http://www.questdiagnostic.com

About Phadia

Children’s hospitals can reduce higher patient occupancy rates most often experienced during weekdays by scheduling more patients to be admitted on days with lighter schedules, according to a study published by researchers from The Children’s Hospital of Philadelphia and other pediatric institutions.

The study, which appears today in the Journal of Hospital Medicine, evaluated inpatient information from 39 children’s hospitals during 2007 and found high midweek occupancy and substantial unused weekend capacity. Hospitals can use a “smoothing” approach to reduce peaks and troughs in census over the course of the week in order to  protect patients from crowded conditions, the study found.

Hospitals typically have uneven patient volume over days of the week. High occupancy levels, often referred to as “crowding,” may compromise patient safety and access to care. Meanwhile, low levels are often considered inefficient.  In the study of 39 children’s hospitals, weekday occupancy ranged between 71 percent and 108 percent while weekends had occupancy of 66 percent to 94 percent. Smoothing involves spreading the week’s volume of patients more evenly.

“Children’s hospitals have substantial unused capacity that could be used to smooth occupancy,” said study leader Evan Fieldston, M.D., M.B.A., M.S.H.P., a pediatric researcher at The Children’s Hospital of Philadelphia. “The concept is to proactively control the entry of patients, to achieve more even levels of occupancy instead of peaks and troughs.”

The researchers used 2007 data obtained from the Pediatric Health Information System (PHIS), a national administrative database that contains information from 39 freestanding children’s hospitals. The researchers retroactively calculated each hospitals’ average occupancy for the week and created a formula to alleviate times when patient census peaks.

About 15 percent to 30 percent of patient visits are scheduled weeks or months in advance, and most often on weekdays. Only about 12 percent of scheduled admissions occurred during the weekends. The study forecast a reduction in weekly occupancy of more than 6 percent by smoothing out admissions. To achieve this, an average of about 7 patients per week would have to be scheduled on a different day, the study authors said.

Smoothing does not necessarily require weekend admissions. For example, patients could enter on a Friday with an anticipated discharge of Monday, the authors said. Further studies should look at child, family and staff preferences for scheduling admissions around school and work, as well as local circumstances that vary at each hospital.

Other study authors are Susmita Pati, M.D., M.P.H. and Samir S. Shah, M.D., M.S.C.E,  of Children’s Hospital of Philadelphia; Matthew Hall, Ph.D., of the Child Health Corporation of America in Shawnee Mission, Kansas; Marion R. Sills, M.D., M.P.H., of Children’s Hospital in Aurora, Colorado; Anthony D. Slonim, M.D., Dr.P.H., of the Carilion Clinic Children’s Hospital in Roanoke, Virginia; Angela L. Myers, M.D., M.P.H., of Children’s Mercy Hospital in Kansas City, Missouri; and Courtney Cannon, M.B.A., of Children’s Hospital Boston.

Dr. Fieldston received support from the Robert Wood Johnson Foundation’s Clinical Scholars program. Dr. Sills received support from the Agency for Healthcare Research and Quality. Dr. Shah received support from the National Institute of Allergy and Infectious Diseases and the Robert Wood Johnson Foundation under its Physician Faculty Scholar Program.

Full citations: Fieldston ES, Hall M, Shah SS, Hain PD, Sills MR, Slonim AD, Myers AL, Cannon C, Pati S; Addressing Inpatient Crowding by Smoothing Occupancy at Children’s Hospitals; Journal of Hospital Medicine, 2011, DOI: 10.1002/jhm.904

Early results from the largest cross-sectional national allergy study ever conducted, to be released later this week, suggest that allergies have increased in America, but that most of the increase was due to two environmental allergens, ragweed and mold. The study, based on nearly 14 million test results from more than 2 million patient visits, is believed to be the largest to suggest that increased prevalence of the two allergens, which have been associated with climate change, are largely responsible for an increase in allergies in the United States.

The Quest Diagnostics Health Trends™ Report, Allergies Across America™, from Quest Diagnostics (NYSE: DGX), evaluates results of ImmunoCAP® specific Immunoglobulin E (IgE) blood testing to 11 common allergens, including common ragweed and mold, two house dust mites, cats and dogs, and five foods. A high IgE sensitization level for a specific allergen tested is highly suggestive of an allergy, although physicians also evaluate symptoms, medical history and other factors in order to clinically diagnose an allergy.

In the study, sensitization rates to common ragweed and mold increased the most of the 11 common allergens evaluated over a four-year period. Sensitization to common ragweed grew 15% nationally while mold grew 12%. By comparison, sensitization to the 11 allergens combined increased 5.8%.

“We believe this is the first large national study to show that the growing prevalence of allergies, suggested by other studies, is largely due to increases in environment-based allergens previously associated with climate change,” said Stanley J. Naides, M.D., medical director, immunology, Quest Diagnostics. “Given concerns about a warming climate, additional research is needed to confirm these findings and assess the possible implications for public health.”

About 10% to 20% of Americans are sensitive to ragweed. Increased exposure to ragweed has been shown to increase an individual’s risk of developing a ragweed allergy or of experiencing more severe allergy symptoms. Research has shown that a warming climate, by promoting longer blooming seasons, may increase both the abundance of certain environmental allergens, including ragweed, in the environment and length of the year during which people are exposed. A study published in March 2011 in the Proceedings of the National Academy of Sciences determined that the ragweed season was nearly a month longer in 2009 than it was in 1995 in certain northern areas of North America, possibly as a result of climate change.  Mold, as a precipitation-affected aeroallergen, may also increase in prevalence with a warmer climate.

The Quest Diagnostics study also ranked the 30 most populous metropolitan areas (“cities”) in the United States for IgE sensitization to ragweed. In the “30 Worst Big Cities for Ragweed” ranking, Phoenix, Las Vegas, Kansas City, Riverside-San Bernardino in California, and Dallas showed the highest rates of ragweed sensitization, while Miami, San Francisco, Portland, Tampa, and San Diego showed the lowest. Those cities at the high end of the ranking showing sensitization levels nearly three times higher than those at the low end.

On a regional basis, ragweed sensitization was highest in the Southwest, Great Lakes, and Mountain and Plains States. The investigators theorized that the differences in ragweed sensitization regionally and in the most populous cities may in part be due to longer and more intense ragweed pollen seasons, but they also underscored that the reasons behind these difference are unclear and deserve additional study.

“Considering that the ragweed season traditionally begins in August, Americans suffering from ragweed allergies should expect a very long summer,” said Dr. Naides. “These individuals as well as those with other allergies or asthma should take proactive measures to reduce their exposure to ragweed over the next several months.”

United Steelworkers (USW) said today that it has taken the first step toward filing a lawsuit against OMNOVA Solutions, Inc. by providing notice of intent to file in United States Federal District Court. Parties joining in the USW suit are The Center for Health, Environment & Justice (CHEJ), and the Blue Ridge Environmental Defense League (BREDL).

The suit would fall under the Emergency Planning and Community Right-To-Know Act of 1986 for what appears to be insufficient reporting of the storage and release of toxic chemicals to the environment from the company’s Performance Chemicals Facility in Chester, S.C.  Product focus at this facility consists of chemicals for floor care, graphic arts, coatings, adhesives, tape, construction, paper and textiles.

In a letter sent today by USW, CHEJ and BREDL to fulfill the 60-day notice requirement to perfect jurisdiction to bring the citizen suit, the groups allege that the company failed to accurately complete and submit required Toxic Chemical Release Forms for 2008 and 2009 to report releases of Potassium Permanganate and Toluene Diisocyanate. The groups also allege that the company failed to report their 2008 releases of Isopropyl Alcohol. Under the law, OMNOVA could be subject to civil penalties up to $32,500 per violation, per day with liabilities that ultimately could reach millions of dollars.

“We have found that employers who disrespect workers often treat the environment with the same contempt,” said USW Special Counsel Lynn Agee. “Until OMNOVA starts obeying our laws and respecting workers, we’ll continue in our efforts to bring the company to justice.”

“The League’s members in the Carolinas are united in support of this action,” stated Louis Zeller, Legal Director, Blue Ridge Environmental Defense League. “We cannot allow companies to ignore toxic chemical reporting; it’s our right to know.”

While all three chemicals can irritate the nose and throat, health warnings advise that Toluene Diisocyanate may cause cancer, lung irritation and an asthma-like allergy.  Potassium Permanganate may decrease fertility and affect the liver and kidneys.

The Chester facility is one of six OMNOVA plants that stores large volumes of extremely hazardous chemicals in quantities that EPA deems a potential public risk and subject to Risk Management Planning.

“Community members and workers have the need as well as the right to know about hazardous chemicals used and released by OMNOVA,” said Lois Marie Gibbs, Executive Director of the Center for Health, Environment & Justice (CHEJ).  “Corporations like OMNOVA need to come clean and fully inform the public and workers about toxic chemicals stored at their facilities and released into communities.”

As Americans take a more active role in managing their health and well-being, Ford researchers are taking a leading role in developing a series of health and wellness in-car connectivity solutions designed to empower people with self-help information while they drive.

• Ford researchers demonstrate a series of possible in-car health and wellness connectivity services and apps aimed at helping people with chronic illnesses or medical disorders such as diabetes, asthma or allergies manage their condition while on the go

• Leveraging Ford SYNC®, researchers developed glucose device connectivity and monitoring capability, location-based allergy and pollen reports and voice-controlled, cloud-based health management services

• Ford is working with leading healthcare industry experts such as medical device maker Medtronic, mHealth pioneer WellDoc®, and SDI Health, developers of the informational allergy website www.pollen.com, to develop its initial Health and Wellness connectivity portfolio

Leveraging Ford SYNC® and its ability to connect devices via Bluetooth, access cloud-based Internet services and control smartphone apps, Ford is taking charge in this automotive whitespace area, developing industry-first voice-controlled in-car connections to an array of health aids from glucose monitoring devices, diabetes management services, asthma management tools and Web-based allergen alert solutions.

“Ford SYNC is well known in the industry and with consumers as a successful in-car infotainment system, but we want to broaden the paradigm, transforming SYNC into a tool that can help improve people’s lives as well as the driving experience,” said Paul Mascarenas, chief technology officer and vice president, Ford Research and Innovation.

Healthy statistics

Health of mind, body and spirit is a significant slice of a larger global health and wellness trend that is transcending multiple generations, spectrums and industries. So-called healthy homes, allergen-free cleaners and products, and the cosmetic and bariatric surgery boon, for example, are all converging to create an eclectic mash-up that is redefining health and wellness for today’s consumer.

An underlying consumer demand for being in the know about one’s health while on the go also continues to rise, fueling the growing number and breadth of mobile healthcare devices and health- and fitness-related software and smartphone applications hitting the market today.

According to a recent survey conducted by CTIA-The Wireless Association and Harris Interactive, for example, some 78 percent of U.S. consumers expressed interest in mobile health solutions. A recent study by digital messaging powerhouse MobileStorm further confirmed this phenomenon, indicating that medical and healthcare apps was the third fastest-growing category of smartphone applications in early 2010. The major app stores, such as the Apple App Store, are now housing upward of 17,000 available health apps for download, with nearly 60 percent of those aimed at consumers rather than healthcare professionals, reports mobile research specialist Research2Guidance.

“Wireless health provides an unprecedented ability for monitoring and promotion of health and wellness for all individuals,” said UCLA Electrical Engineering Professor William Kaiser, who has worked with NASA and the U.S. Department of Homeland Security’s Science and Technology Directorate to study how wireless health technologies can be used to track an individual’s fitness and health status and help identify potential risks and challenges. “Studies show wireless health empowers people with information and guidance that can directly address the most important health concerns.

“The new Ford health and wellness connectivity solutions represent a fundamental advancement for these individuals,” Kaiser added, “providing them additional support and functionality during time spent in the vehicle.”

Constant connections

Taking a smart, high-volume approach to bringing mobile health and wellness solutions inside the car, Ford researchers are first looking at two populations with the most need for a constant connection to potentially life-saving medical information – people with diabetes and those with asthma and/or allergies.

According to the American Diabetes Association, nearly 26 million adults and children are currently living with diabetes in the U.S., 3-plus million more than there were four years ago. Numbers grow even higher for those with asthma and allergies, with the Asthma and Allergy Foundation of America reporting some 60 million Americans have asthma and/or allergies.

To create relevant in-car features and services for those living with these ailments, Ford is working with experts in these fields, including medical device manufacturers, healthcare management service providers and Web-based medical alert services.

“Ford’s approach to health and wellness in the vehicle is not about trying to take on the role of a healthcare or medical provider, we’re a car company,” said Gary Strumolo, global manager, Interiors, Infotainment, Health & Wellness Research, Ford Research and Innovation. “Our goal is not to interpret the data offered by the experts, but to work with them to develop intelligent ways for Ford vehicles using the power of SYNC. In essence, creating a secondary alert system and alternate outlet for real-time patient coaching services if you will.”

For people with diabetes and their caregivers, constant knowledge and control of glucose levels is critical to avoiding hypoglycemia or low glucose, which can cause confusion, lightheadedness, blurry vision and a host of other symptoms that could be dangerous while driving. Many now depend on a portable continuous glucose monitoring device to track their levels.

Likewise, those with asthma and allergies need to have a clear understanding of their environment and potential symptom triggers – such as pollen levels in the air – that can quickly lead to an attack. Growing in popularity among this group are Web-based alert services and smartphone apps that can help flag dangerous pollen levels based on location.

Ford SYNC offers three unique ways to bring health and wellness connected services into the car:

• Device connectivity via Bluetooth – Leveraging Bluetooth, medical devices can be connected to the car to share information through SYNC, just like a driver connects and accesses his or her cellphone and address book by voice control

• Cloud-based services – Ford created an off-board network of location-based traffic, directions and information providers that drivers can simply access via their cellphone. Known as SYNC Services, new services such as medical services can be easily added through this plug-and-play voice-controlled capability

• AppLink – Ford’s latest SYNC innovation allows smartphone apps to be accessed by drivers via voice control. The SYNC application programming interface (API) allows app developers to enable their apps to communicate through SYNC, delivering a smarter way for drivers to manage apps while driving

The ongoing Ford health and wellness research projects encompassing these needs include:

• Glucose monitoring: Working with Medtronic, a leading manufacturer of glucose monitoring devices, Ford researchers have developed a prototype system that allows Ford SYNC to connect via Bluetooth to a Medtronic continuous glucose monitoring device and share glucose levels and trends through audio and a center stack display and provide secondary alerts if levels are too low.

“To address the growing challenge of chronic diseases, Medtronic is collaborating with companies like Ford to develop innovative solutions,” said James Dallas, senior vice president, Medtronic. ”Diabetes in particular is a chronic disease where frequent monitoring of blood glucose levels throughout the day is critical. As medical and consumer technologies converge, Medtronic is uniquely positioned to provide patients, caregivers and physicians with actionable insight from the data our devices can gather from the human body. By utilizing information technology and consumer electronic devices, we can help patients actively manage their health via access to real-time data on phones, hand-held devices or even in their cars.”

• Allergy alerts: Ford is working with SDI Health and www.pollen.com to SYNC-enable its smartphone Allergy Alert app through AppLink, giving users voice-controlled access to the app that provides location-based day-by-day index levels for pollen; asthma, cold and cough and ultraviolet sensitivity; as well as four-day forecasts.

“Our developers initially created the iPhone app to provide users with greater access to the information they’ve come to rely on from pollen.com,” said Jody Fisher, vice president of Marketing for SDI. “Having instant, portable access for their conditions helps users plan their day or week ahead so they can remain active, which ultimately improves their quality of life.

“Collaborating with Ford is the perfect extension of this objective,” Fisher said. “We are happy to support Ford’s initiative of connecting drivers with resources and services important to their health and wellness.”

• WellDoc: Ford and WellDoc, a recognized leader in the emerging field of mHealth integrated services, have joined forces to integrate in-car accessibility to WellDoc’s comprehensive cloud-based personalized solutions for those with asthma and diabetes through SYNC Services. Using voice commands, SYNC users could access and update their WellDoc profile to receive real-time patient coaching, behavioral education and medication adherence support based on their historic and current disease information.

“WellDoc was founded on the concept of helping patients manage their disease with everyday, personal tools that are easy to use and can be easily accessed,” said Dr. Anand K. Iyer, president and COO of WellDoc. “Through our partnership with Ford, we’ve created a unique in-vehicle environment that supports patients so they can continuously maintain their daily routines without interruption.”

Well on the way

Although still in the prototype and research phase, Strumolo acknowledges that many of the health and wellness features and services being explored at Ford have fairly short-term implementation requirements, such as the Allergy Alert app.

Ford is also examining other more long-term health and wellness technologies and ideas related to, for example, heart rate, relaxation and reducing stress. Ford and the Massachusetts Institute of Technology (MIT) have long been studying the correlation between stressors and driving performance, wrapping up a nine-month advanced research project last fall that showed drivers are less stressed when using selected vehicle technologies such as Ford active park assist and cross-traffic alert.

“Health and wellness provides a tremendous opportunity for Ford to provide peace of mind and a personal benefit to drivers and passengers while they are in our vehicles,” said Strumolo. “As more and more devices and technologies lend themselves to such connectivity in the car, it is our responsibility, our philosophy, to examine those possibilities and open our doors to industry relationships that can help us do it intelligently, efficiently and economically.”

Perrigo Company (Nasdaq: PRGO; TASE) and its partner Synthon Pharmaceuticals, Inc. today announced that it has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Levocetirizine Solution, 2.5 mg/5ml, a generic version of UCB’s Xyzal® Oral Solution. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.

Xyzal® Oral Solution is indicated for the treatment of indoor and outdoor allergies. It is estimated that it has annual sales of approximately $15 million dollars growing at 15% per year, according to data provided by Wolters, Kluwer.

Perrigo’s Chairman and CEO Joseph C. Papa concluded, “This is another example of Perrigo’s commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers.”

Synthon’s CEO Rudy Mareel, commented, “Levocetirizine is a prime example of several ANDAs for which Synthon has obtained ‘First-Filer’-status with 180 days Hatch-Waxman marketing exclusivity. The tentative approval of Levocetirizine oral solution yet again is proof to Synthon’s achievements and our fruitful cooperation with Perrigo.”

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products and active pharmaceutical ingredients (API). The Company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The Company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).

Synthon Pharmaceuticals, Inc., with its U.S. headquarters and laboratories located in Research Triangle Park, North Carolina, markets generic drugs through partnerships with other leading pharmaceutical companies. Synthon currently holds several approved, or tentatively approved, drug applications and has a pipeline containing more than a dozen products that are expected to be filed with the FDA within the next few years. Synthon Pharmaceuticals, Inc. is part of the Synthon group, a global privately held specialty pharma company with offices, laboratories and manufacturing sites in 11 countries worldwide. (www.synthon.com)

Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections.  While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended June 26, 2010, as well as the Company’s subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Early results from the largest cross-sectional national allergy study ever conducted, to be released later this month, demonstrate that food allergies commonly occur in infants and toddlers, while environmental allergies, such as to dust, ragweed and mold, are more common in older children and adults. The study, based on laboratory testing from more than 2 million patient visits in the United States, is the largest to reveal a pattern of allergen sensitivity consistent with the “allergy march,” a medical condition by which allergies to foods in early childhood heighten the risk for the development of additional and more severe allergy-related conditions, including asthma, later in life.

The Quest Diagnostics Health Trends Report, Allergies Across America™, from Quest Diagnostics (NYSE: DGX), the world’s leading diagnostic testing company, also found that patients with asthma who were tested for allergies were 20% more likely to have an allergy, particularly to indoor allergens like mold and house dust mites, compared to patients tested without asthma, based on an analysis of test results showing immunoglobulin E (IgE) sensitivity to certain allergens. The findings support medical guidelines recommending that clinicians and patients with asthma identify and minimize potential allergens in the home and workplace that could aggravate the disease.

“Allergy and asthma often go hand in hand, and the development of asthma is often linked to allergies in childhood via the allergy march,” said study investigator Harvey W. Kaufman, M.D., senior medical director, Quest Diagnostics. “Given the growing incidence of asthma in the U.S., our study underscores the need for clinicians to evaluate and treat patients, particularly young children, suspected of having food allergies in order to minimize the prospect that more severe allergic conditions and asthma will develop with age. It also demonstrates that patients with asthma should minimize their exposure to allergens that could trigger a severe asthma response.”

Allergies are one of the most common health conditions, affecting one in five Americans. A report out this month from the U.S. Centers for Disease Control and Prevention shows the prevalence of asthma is increasing, and now affects one in 12 adults and nearly one in ten children. Allergy-induced asthma is the most common type of asthma in the U.S.

Childhood Food Allergies

The Quest Diagnostics study found that children through the age of eight who were tested were most likely to experience high food allergy rates. Specifically, the study’s childhood food allergy analysis found:

• Egg White and Milk. Thirty-seven percent of infants and toddlers tested were sensitive to egg white and 36% of three year olds were sensitive to milk.
• Peanuts. Peanuts were the most common source of food allergy in children six to 18 years of age, affecting approximately one in four (26 %) school-aged children tested. Yet, peanut allergies were even more prevalent in children five years of age and younger, affecting about 30% of children tested in this age group.
• Wheat. Nearly one in four (23%) children tested through the age of ten exhibited wheat allergen sensitization, although the rate declined after that age.

After the age of eight, rates of food allergies overall declined, while sensitivity to non-food allergens increased, consistent with the allergy march. Sensitivity to environmental allergens, including house dust mites, cats, dogs, and common ragweed, remained at high levels through the age of 40.

Disadvantaged Children

The investigators also compared testing rates for children with private health insurance and government-administered Medicaid plans. Children five years of age and younger enrolled in Medicaid were 18% less likely to be tested than children of the same age group covered by private health insurance, suggesting that economically disadvantaged children may be less likely to be tested at early ages. Other research demonstrates that early intervention can minimize the likelihood of progression to more severe allergic diseases, including asthma.

“Quest Diagnostics’ findings provide compelling evidence that economically disadvantaged children are less likely to receive the level of health care that can promote favorable outcomes,” said Gary Puckrein, Ph.D., executive director, Alliance of Minority Medical Associations, and a report advisor. “This research should prompt policy makers, physicians, and, of course, parents to consider how different types of health plans may impact the quality of the health services our children receive.”

Methodology of the Quest Diagnostics Health Trends Report Allergies Across America

The Allergies Across America study is broadly representative of the overall population of patients seeking medical care for allergy-like symptoms from healthcare professionals in the U.S. It includes de-identified test results of patients from infancy to 70 years of age living in every U.S. state and the district of Columbia. The study did not track individual patients longitudinally, so age-related patterns do not necessarily imply that specific individuals developed other allergy conditions or asthma over time.  However, the pattern of allergen sensitivity observed in this study is consistent with other, but smaller cross-sectional studies.

The study was based on de-identified results of testing in Quest Diagnostics clinical laboratories using the ImmunoCAP® specific immunoglobulin E (IgE) blood test, the “gold standard” of allergy blood tests. IgE is an antibody in blood produced by the body’s immune system when an allergen is present. Each test result identified sensitization to one or more of 11 common allergens: five foods (egg white, milk, peanut, soybean, and wheat), common ragweed, mold, two types of house dust mites, and cats and dogs. While high IgE sensitization level is suggestive of an allergy, clinical diagnosis also requires medical examination and other considerations, and therefore the study did not definitively conclude patients with high sensitization were allergic to a tested allergen. A patient visit refers to any instance where an individual patient was tested at least once for one or more of the 11 allergens by Quest Diagnostics over the four-year period examined for the study.

The full Allergies Across America report to be released this month will assess the health impact of the 11 allergens on patients nationally and regionally as well as on the 30 most populous cities in the United States.