Dietary supplement Zencore Tabs recalled

The maker of Zencore Tabs, marketed as a dietary supplement to enhance male sexual stamina, is recalling the product because it contains undeclared ingredients including aminotadalafil and sildenafil, chemicals whose derivatives are used in prescription medicines for erectile dysfunction, the U.S. Food and Drug Administration said Friday.
These and two other chemical ingredients, sulfosildenafil and sulfohomosildenafil, may interact with nitrates found in certain prescription drugs and could lower blood pressure to dangerous levels, the FDA said in a statement.
Zencore is marketed by Los Angeles-based Bodee LLC.
Consumers who have this product are urged to stop using it immediately and to see a health-care professional if they notice any side effects, the FDA said.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Zencore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Tags: Zencore Tabs, Zencore Tabs recall, aminotadalafil, sildenafil, erectile dysfunction, Bodee LLC, FDA, Medwatch

Blue Shield California Foundation Launches Clinic Leadership Institute

SAN FRANCISCO--(BUSINESS WIRE)--Blue Shield of California Foundation (BSCF) today announced plans to spend up to $10 million over 5 years to support its first signature project, the Clinic Leadership Institute, an innovative program that aims to identify and train the next generation of California’s community clinic leaders.

The Clinic Leadership Institute is being launched with an initial grant of $1.39 million, which was part of this year’s third quarter grant making. The funding will be used to recruit, select and train the inaugural class of 25 emerging clinic leaders. Those selected will learn leadership, decision making, financial management and strategic planning skills during the course of the 18 month Institute. The goal is to provide these emerging leaders with the skills to become effective change agents in today’s rapidly evolving health care environment.

“Community-based clinics today face a major leadership transition,” said BSCF President and CEO Crystal Hayling. “Those who pioneered the community-based clinic movement had the vision to establish our healthcare safety net. As 70 percent of today’s community clinic leaders prepare to retire, the Clinic Leadership Institute will prepare a new generation to take the helm.”

Community clinics are a vital part of California’s healthcare safety net. Today, more than 800 clinics throughout California provide healthcare services to nearly 3 million people, including 12 percent of California’s children and 37 percent of those living below the poverty level.

The Clinic Leadership Institute grows out of BSCF’s deep and longstanding commitment to supporting California’s healthcare safety net. Since 2003, BSCF has provided $29 million in core support funding to community clinics statewide.

“As a result of this program, we hope the next generation of healthcare leaders will be better prepared to serve the millions of Californians who rely on community clinics for the care they need to keep themselves and their families well,” Hayling said. “We hope to build a learning network of clinic leaders.”

BSCF selected the Center for the Health Professions at the University of California – San Francisco (UCSF) to develop and administer the Clinic Leadership Institute. Developed with input from California community clinic representatives, as well as regional and national experts in the field of leadership development, the Institute offers a comprehensive curriculum and hands-on training that addresses core competencies in:

• Organization Values and Behaviors
• Leadership and Decision Making
• Strategic Thinking and Acumen
• Business Acumen and Financial/Grant Management
• Relationship Management
• Diversity
• Organization Improvement
• Data Driven Decision Making

The Clinic Leadership Institute is now accepting applications for its inaugural class, with a deadline of October 31, 2007. Applicants will be recruited from every region of the state and will be representative of its full economic, social and cultural diversity. Those interested in more information should visit www.clinicleadershipinstitute.org.

Tags: Blue Shield, BSCF, Clinic Leadership Institute, health care, healthcare, University of California, UCSF

Popcorn suppliers drop toxic chemical diacetyl

ConAgra, the world's largest supplier of the 3 billion bags of microwave popcorn sold each year, said Tuesday that it will eliminate the use of a controversial chemical butter flavoring linked to severe lung disease in workers from its Act II and Orville Redenbacher products.
The announcement comes a week after Pop Weaver, the nation's second-largest popcorn producer, said it already had pulled the synthetic flavoring -- diacetyl -- from its microwave product delivered to stores last month.
Meanwhile, a lung specialist from Denver's National Jewish Medical and Research Center has notified federal agencies that she may have identified the first known case of a man who ate popcorn at home and had the same disease as the workers.
Lung specialist Dr. Cecile Rose wrote to the Food and Drug Administration, the Environmental Protection Agency, the Centers for Disease Control and Prevention and the Occupational Health and Safety Administration in July, advising them of her patient and the possibility that people who pop microwave corn at home can be at risk.
The rare lung disease that Rose diagnosed in her patient -- bronchiolitis obliterans -- can cause death in severe cases. Lung transplants are the only hope that patients have. The disease quickly leads to breathing difficulties and is often misidentified by physicians unfamiliar with the disease.
news source

Tags: popcorn, ConAgra, Act II, Orville Redenbacher, Pop Weaver, diacetyl, FDA, bronchiolitis obliterans

Mattel Announces Recall of Additional 11 Toys as a Result of Extensive Ongoing Investigation and Product Testing

EL SEGUNDO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- Mattel, Inc. announced today that, as a result of the company's ongoing investigation of its toys manufactured by vendors in China, the company has voluntarily recalled 11 toys globally, including eight pet and furniture playsets sold under the Barbie(R) brand and three Fisher-Price(R) toys, due to impermissible levels of lead. No Barbie(R) dolls are included within the recall. In total, there are 522,000 affected toys in the U.S., and 322,000 affected toys outside of the U.S. Mattel has completed the testing program for the majority of its toys, including all of its toys currently sourced from vendors.

The voluntary recall results from Mattel's thorough investigation of vendor-sourced toys. Mattel has also globally implemented a strengthened, three-point check system to test toys throughout the manufacturing process.

"In August we promised that we'd continue to focus on ensuring the safety and quality of our toys through extensive testing of finished products, thorough investigation of our vendors and the implementation of a strengthened three-point check system. As a result of our ongoing investigation we discovered additional affected products. Consequently, several subcontractors are no longer manufacturing Mattel toys. We apologize again to everyone affected and promise that we will continue to focus on ensuring the safety and quality of our toys," said Robert A. Eckert, chairman and chief executive officer, Mattel.

In the U.S., there are seven recalled Barbie(R)-branded toys. The specific affected parts include:

    -- Dream Puppy House(TM)- orange on miniature dog
   -- Dream Kitty Condo(TM)- brown on miniature cat
   -- Table & Chairs Kitchen Playset - yellow food on two dinner plates,
      brown on miniature dog, yellow and orange on potato chip bowl, orange
      on salad bowl
   -- Bathtub & Toilet Playset - brown on miniature cat
   -- Desk & Chair Bedroom Playset - brown on miniature dog
   -- Living Room Playset (deluxe) - brown on miniature cat
    -- Living Room Playset (premium) - yellow flower on purse

The playsets affected by the recall were produced by Holder Plastic Company (Holder), a Mattel contract vendor, which subcontracted the painting of miniature toy pets and small furniture pieces to Dong Lian Fa (DLF) and Yip Sing (YS). DLF and YS used uncertified paint and are no longer producing toys for Mattel.

Mattel's investigation revealed that the subcontractors painted the affected toys between March 2007 and August 2007. However Mattel is being cautious and recalling the entire production of the seven toys painted by the subcontractors. Therefore, toys manufactured beginning in October 2006 are included within the recall. The toys being recalled were sold at retail between November 2006 and August 2007.

Among the three Fisher-Price(R) toys recalled are two Fisher-Price(R) GEOTRAX(TM) toys and one "It's a Big Big World" toy. Fisher-Price(R) toys with specific parts affected include:

    -- GEOTRAX(TM) Rail & Road System Freightway Transport(TM)- yellow
      headlights on train car and miniature ladder
   -- GEOTRAX(TM) Special Track Pack(TM) - yellow headlights on train car and
       miniature ladder
   -- "It's a Big Big World" 6-in-1 Bongo Band - painted decal on top of
      clear plastic on drum

The two GEOTRAX(TM) toys were manufactured by Apex Manufacturing Company Ltd. (Apex), one of Mattel's contract vendors, which outsourced paint work to a subcontractor, Boyi Plastic Products Factory (Boyi). Apex supplied Boyi with certified paint; however, the toys were manufactured with uncertified paint. Boyi is no longer in business. The two GEOTRAX(TM) toys that tested for impermissible levels of lead were manufactured between July 31, 2006, and September 4, 2006; however, the painted parts were stored and incorporated into toy production throughout the year. Mattel is being cautious and recalling toys shipped between August 3, 2006, and July 31, 2007.

The Fisher-Price(R) "It's a Big Big World" 6-in-1 Bongo Band toy was manufactured by Shun On Factory, one of Mattel's contract vendors, which outsourced the molding and painting of one plastic piece. A subcontractor, Jingying Tampo Printing Processing Factory, used uncertified paint on the affected piece. The "It's a Big Big World" 6-in-1 Bongo Band was manufactured between May 19, 2007, and August 1, 2007.

Mattel is working in cooperation with the U.S. Consumer Product Safety Commission and other regulatory agencies worldwide. Mattel is also working with retailers worldwide to identify and remove affected products from retail shelves.

For additional information regarding this recall, including a full list of affected products, please contact Mattel at (888) 496-8330, or visit the company's Web site at http://www.service.mattel.com. A full list of products is also published by the Consumer Products Safety Commission.

    How to Return Affected Toys/Parts:

   1)  The first step is for consumers to determine if they have a toy that
       has been affected by the recall.  To do so, they can visit
        http://www.service.mattel.com where they will find a complete list of
       each toy recalled, including color photos, toy model numbers and
       affected date codes.  Consumers can locate toy model numbers on the
       bottom of most recalled toys.

       For consumers without a computer, or for those preferring phone
       support, they may call (888) 496-8330

   2)  Once consumers determine that they think they own a Mattel toy
       affected by the recall, they are prompted to fill out a form (online)
       or provide their postal address (via phone), and Mattel will send to
       consumers (via email or to a postal address) a color brochure with
       photos, toy numbers and date code ranges of every affected toy, as
       well as a pre-paid mailing label for return of the affected part(s).

   3)  After receiving consumers' returned, affected part(s), Mattel will
       send consumers replacement parts for each affected product, as well as
       bonus pieces/parts.

Mattel recommends that consumers do not return toys to retailers for three reasons:

    1)  Mattel can help consumers determine if a toy has been affected by the
       recall (vs. returning an unaffected toy)

   2)  Mattel will provide consumers with a replacement part for each toy
        part affected by the recall

   3)  Mattel will handle affected products in an environmentally friendly
       way

Consumers do not need to have the toy's original packaging or a receipt to return affected products to Mattel.

Tags: toy recall, mattel, barbie recall, Fisher-Price

New drug for treating schizophrenia

Eli Lilly and Co. is testing a new drug for schizophrenia that it says works quickly and safely without resulting in weight gain, a much-criticized side effect of its top-selling antipsychotic drug Zyprexa.
The Indianapolis drug maker recently tested the new drug on more than 100 schizophrenic patients for four weeks and found it was effective in treating hallucinations, delusions, social withdrawal and apathy, according to a paper published today in the journal Nature Medicine.
Patients who took the drug, LY2140023, showed no weight increase, nor did they exhibit adverse effects commonly associated with many schizophrenia medications, such as involuntary movements or muscle stiffness, the paper said.
Lilly said the new drug works in a completely different way than standard treatments. Most currently approved antipsychotic medications work by affecting the neurotransmitters dopamine or serotonin. The new drug is thought to work by affecting another neurotransmitter, glutamate.
Lilly said the new drug is still years away from clinical use for schizophrenia, a disease that affects about 3 million Americans.
The first new class of drugs in more than a decade for treating schizophrenia worked at least as well in a clinical trial as standard medications, a study released Sunday showed.
Unlike current anti-psychotic drugs, which block the uptake of a naturally occurring chemical called dopamine, the new drug acts on a different neurotransmitter, glutamate.
The new treatment also reduced certain undesirable side-effects, according to the study, published in the British journal Nature Science.
Imbalances in the brain of these chemicals are largely responsible for schizophrenia's disabling symptoms, which range from hallucinations and delusions to a severely impaired ability to express emotion. Environmental factors are thought to play a role too.
Sufferers often hear voices and may believe that other people are reading their minds or controlling their thoughts. These frightening experiences can cause withdrawal and extreme agitation.
AFP@Google

Tags: schizophrenia, LY2140023, antipsychotic, serotonin

Have You Given Blood Lately? Give Blood, Give Life!

As a mantra, I donate blood every year since I was 14 years old. Why? Because I survived a very bad motorcycle accident and all those donors have donated blood, saved my life. While recovering from the accident, I made a promise to myself that I will donate blood as long as I could, to thank for what I received!

Thanks to God, I have been healthy and I could donate blood without any problems. One thing is that you feel very content and happy that your act will help and save someone somewhere. That someone easily could be somebody very close to you.

So what and how does this blood donation work? FDA, Food and Drug Administration, has a Information page. Please see the end of the post to see additional information and links.

Every day, emergency rooms throughout the United States are challenged by large numbers of people who need blood, including victims of fires, floods, storms, and other disasters.

But it's not just accidents or disasters that prompt the need for blood. Blood is needed for many people ranging from those with life-threatening illnesses to others undergoing routine surgeries.

In fact, every two seconds, according to the American Red Cross, someone in America needs blood, such as

• Cancer patients undergoing chemotherapy
• People with sickle cell disease or other types of inherited anemia
• Organ transplant recipients
• People undergoing elective surgery
• Moms-to-be during and following labor and delivery

The Process of Donating Blood

Blood is critically needed every day, yet only about 5% of the eligible U.S. population donates blood in any given year, according to the American Red Cross. Healthy individuals who meet donor eligibility requirements (see below) are urged to give blood.

The entire procedure takes about an hour and includes:

• Registering at the facility
• Answering questions about your health and travel history
• Getting a physical examination
• Donating the blood (about 10 minutes)
• Having a light refreshment to boost your energy level before leaving the facility

Am I Eligible to Donate Blood?

To meet the basic requirements for giving blood, you must

• be healthy (feel well and be able to perform normal activities)
• be at least 17 years old
• weigh at least 110 pounds
• not have donated blood in the last 56 days

A number of conditions, which will be discussed with you at the donation site, make you temporarily or permanently ineligible to give blood, such as

• pregnancy
• past use of needles to take drugs that were not prescribed by a doctor
• being a male who has had sexual contact with another male since 1977
• getting tattooed in the last year
• living in or visiting certain countries during designated periods of time, for example, living a long time in a country where "mad cow disease" is found or visiting an area where malaria is found.

The rules for eligibility are less strict when making donations for your own use during surgery.

For more information about donor eligibility and giving blood, see

Have You Given Blood Lately?

FDA's Center for Biologics Evaluation and Research
www.fda.gov/cber/faq/bldfaq.htm

American Red Cross
www.GiveLife.org
1-800-GIVE-LIFE (448-3543)

AABB (formerly known as the American Association of Blood Banks)
www.aabb.org/content

America's Blood Centers
www.americasblood.org
1-888-USBLOOD (872-5663)

Tags: FDA, donate blood, America's Blood Centers, AABB, American Association of Blood Banks, American Red Cross

Social Life, Health, and Aging Project (NSHAP)

The National Social Life, Health and Aging Project (NSHAP) is the first population-based study of health and social factors on a national scale, aiming to understand the well-being of older, community-dwelling Americans by examining the interactions among physical health, illness, medication use, cognitive function, emotional health, sensory function, health behaviors, and social connectedness. It is designed to provide health providers, policy makers, and individuals with useful information and insights into these factors, particularly on social and intimate relationships. NORC, with Principal Investigators at the University of Chicago, conducted more than 3,000 interviews during 2005 and 2006 with a nationally representative sample of adults aged 57 to 85. Face-to-face interviews and biomeasure collection took place in respondents' homes.
Data collection elicited:
1) demographic characteristics;
2) social networks;
3) social and cultural activity;
4) physical and mental health including cognition;
5) well-being;
6) illness;
7) medications and alternative therapies;
8) history of sexual and intimate partnerships; and
9) patient-physician communication.
NSHAP also collected important health information in the home, prioritizing non-invasive collection techniques and cutting edge technology that minimizes respondent burden. NSHAP plans to conduct follow-up interviews with respondents every three years to collect longitudinal data.
This invaluable data is made available to public through ICPSR.

Tags: Aging Project, NSHAP, Face-to-face interviews, biomeasure collection, physical health, illness, medication use, cognitive function, emotional health, sensory function, health behaviors, social connectedness