Tyson Foods Culls Breeder Hens Exposed To A Low Pathogenic Strain Of Avian Influenza (LPAI).

June 3, 2008 -- Tyson Foods is working cooperatively with the USDA and the Arkansas Livestock and Poultry Commission to manage a flock of breeder hens that has been exposed to a low pathogenic strain of avian influenza (LPAI). Preliminary tests on the flock indicate the presence of antibodies for H7N3 avian influenza, however, there is no indication the birds currently have the virus.

The 15,000 chickens involved show no signs of illness and the situation poses no risk to human health.

The affected birds are at the farm of a contract poultry producer in northwest Arkansas. The discovery came as part of routine, pre-slaughter surveillance conducted by the company. The strain involved is low pathogenic H7N3. It is not the highly pathogenic H5N1 virus that has previously affected birds in Asia, Europe and Africa.

Even though the affected birds do not currently have the virus, the flock is being depopulated today as a precautionary measure and will not enter the human food chain. While the birds’ exposure to this strain of avian influenza poses no risk to human health, USDA’s policy is to eradicate all H5 and H7 subtypes.

As a preventative measure, Tyson is also stepping up its surveillance of avian influenza in the area. The company plans to test all breeder farms that serve the local Tyson poultry complex, as well as any farms within a ten mile radius of the affected farm.

The increased surveillance is in addition Tyson’s existing testing program, which involves the company checking all flocks for avian influenza before they leave the farm. The test results are known before the birds are shipped to a Tyson plant for processing.

Contact: Gary Mickelson 479-290-6111

Tags: avian influenza, H7N3, low pathogenic avian influenza, H5N1 virus, Tyson Foods

Elderly Population Could Avoid Memory Loss With Active Social Life, Party Time!!

Active Social Life May Delay Memory Loss Among U.S. Elderly Population

Boston, MA -- One of the features of aging is memory loss, which can have devastating effects on the quality of life among older people. In a new study, Harvard School of Public Health (HSPH) researchers found evidence that elderly people in the U.S. who have an active social life may have a slower rate of memory decline. The study appears in the July 2008 issue of the American Journal of Public Health and appears in an advance online edition on May 29, 2008.

"We hope this study adds to and advances our growing understanding of the important role that social forces play in shaping health," said Karen Ertel, postdoctoral fellow in the Department of Society, Human Development and Health at HSPH.

Previous studies have suggested that an active social life may reduce the risk of dementia and cognitive decline among the elderly. Memory loss is a strong risk factor for dementia, a syndrome estimated to affect up to 10% of the U.S. population 65 years and older. The researchers wanted to test whether memory loss might also be associated with social connectedness.

Ertel and her HSPH colleagues, senior author Lisa Berkman, chair of the Department of Society, Human Development and Health, and Maria Glymour, assistant professor, Department of Society, Human Development and Health, used data gathered from 1998 to 2004 from the Health and Retirement Study, a large, nationally representative population of U.S. adults 50 years and older. (Previous studies were conducted outside of the U.S. or using smaller, non-representative population samples.) Memory was assessed in 1998, 2000, 2002 and 2004 by reading a list of ten common nouns to survey respondents, then asking them to recall as many words as possible immediately and after a five-minute delay. Social integration was assessed by marital status, volunteer activities, and contact with parents, children and neighbors.

The results showed that individuals with the highest social integration had the slowest rate of memory decline from 1998 to 2004. In fact, memory decline among the most integrated was less than half the rate among the least integrated. These findings were independent of sociodemographic factors (such as age, gender, and race) and health status in 1998. The researchers found that the protective effect of social integration was largest among individuals with fewer than 12 years of education.

The researchers found no evidence that the results could be due to reverse causation, that is, poor memory or memory decline causing social withdrawal.

"Social participation and integration have profound effects on health and well being of people during their lifetimes," said Berkman. "We know from previous studies that people with many social ties have lower mortality rates. We now have mounting evidence that strong social networks can help to prevent declines in memory. As our society ages and has more and more older people, it will be important to promote their engagement in social and community life to maintain their well being."

Memory loss and dementia pose a major public health burden among the elderly U.S. population. The results suggest that increasing social integration may help slow memory decline among older Americans and could help alleviate the public health burden, particularly because the aging population in the U.S. is expected to increase substantially. "We need to understand more about how social integration reduces the risk of memory decline in order to target interventions that can help slow the decline," said Ertel. "Future research should focus on identifying the specific aspects of social integration most important for preserving memory."

Support for the study was provided by the National Institute of Aging.

"Effects of Social Integration on Preserving Memory Function in a Nationally Representative U.S. Elderly Population," Karen A. Ertel, M. Maria Glymour, Lisa F. Berkman, American Journal of Public Health, July 2008, Vol. 98, No. 7.

For more information, contact:

Todd Datz

617-432-3952

tdatz@hsph.harvard.edu

Tags: Health Research, Public Health, Memory Loss, HSPH, social life, dementia, Department of Society, Human Development and Health, social integration, American Journal of Public Health, Harvard School of Public Health

FDA Warning, New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes, Salmonella Outbreak

FOR IMMEDIATE RELEASE June 3, 2008

Media Inquiries: Michael Herndon, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes

The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma, or round red tomatoes are the cause. At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, and tomatoes grown at home.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers in New Mexico and Texas who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

From April 23 though June 1, 2008, there have been 57 reported cases of salmonellosis caused by Salmonella Saintpaul in New Mexico and Texas, including 17 hospitalizations. Approximately 30 reports of illness in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas, and Utah are currently being investigated to determine whether they are also linked to tomatoes. There are no reported deaths.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source and type of the contaminated tomatoes. As more information becomes available, FDA will update this warning.

Last year FDA began a multi-year Tomato Safety Initiative to reduce the incidence of tomato-related foodborne illness. The Initiative is a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry.

A key element of the Food Protection Plan -- a scientific and a risk-based approach to strengthen and protect the nation's food supply—is prevention. FDA encourages producers to critically reexamine their operations and apply the scientific principles and regulations established decades ago to provide a safe product for the consumer.

Information on safe handling of produce can be found at www.cfsan.fda.gov/~dms/prodsafe.html.

Tomato consumer page can be found at http://www.fda.gov/oc/opacom/hottopics/tomatoes.html

Updates from the Centers for Disease Control and Prevention can be found at http://www.cdc.gov/

Tags: Salmonella Outbreak, CDC Warning, FDA Alert, Raw Red Tomatoes

Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

Click On The Image Above To Download A PDF Version Of This Report

Albuterol is a quick-relief medication that's used to open up the airways so that it's easier to breathe. The medication is used by people with certain airway diseases, such as asthma and chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema.

One method of delivering albuterol is the metered dose inhaler, a hand-held device that delivers a specific amount of medication directly into the lungs. Traditionally, inhalers have contained chlorofluorocarbons (CFCs), a type of propellant that helps the albuterol reach the lungs. But inhalers with CFCs are being phased out because they are harmful to the environment.

Here are facts you should know about switching from your CFC-propelled albuterol inhaler to inhalers that contain propellants called hydrofluoroalkanes (HFAs).

CFCs deplete the ozone layer.

CFCs deplete ozone high up in the stratosphere--the part of the earth's atmosphere that protects us from the sun's harmful ultraviolet radiation. In the stratosphere, the ozone layer serves as a shield that absorbs ultraviolet radiation and keeps it from reaching the earth's surface. CFCs are among the substances that damage the ozone layer. This leads to higher levels of ultraviolet B radiation, which has negative effects, including increases in skin cancers and cataracts. Under an international agreement, the United States, along with almost all countries of the world, agreed to phase out CFCs and other ozone-depleting substances.

CFC-propelled albuterol inhalers will no longer be available after Dec. 31, 2008.

In accordance with an FDA Final Rule and under the authority of the Clean Air Act of the U.S. Environmental Protection Agency, no CFC-propelled albuterol inhalers can be produced, marketed, or sold in the United States after Dec. 31, 2008. Manufacturers have been increasing production of HFA-propelled albuterol inhalers so that sufficient supplies exist to replace the CFC-containing inhalers. If you haven't done so already, you should talk with your health care professional about switching to an HFA-propelled albuterol inhaler.

Albuterol inhalers containing HFAs deliver the same medicine, but there are some differences.

The HFA-propelled albuterol inhalers are still convenient and have been shown to be safe and effective in studies with patients. But you may find that the spray from an HFA inhaler tastes and feels different than the spray from the CFC-propelled albuterol inhalers. The spray from an HFA inhaler may feel less forceful, but this does not mean that the medication is not working.

Cleaning and priming your HFA inhaler are especially important.

Cleaning and priming helps prevent medication build-up and blockages, and ensures that the inhaler works properly. Priming an inhaler involves shaking it well and then releasing test sprays into the air. Be sure to hold the inhaler away from your face so that you don't get medication in your eyes. Each inhaler has specific instructions for cleaning and priming that you should follow. Refer to the patient information that accompanies the product.

Four alternative HFA-propelled inhalers are approved by FDA.

There are four products available that can be used to replace your CFC-propelled albuterol inhaler:

• Proair HFA Inhalation Aerosol (Ivax Corp.)
• Proventil HFA Inhalation Aerosol (Schering-Plough)
• Ventolin HFA Inhalation Aerosol (GlaxoSmithKline)
• Xopenex HFA Inhalation Aerosol (Sepracor)

While they have all been shown to be effective, there are some differences between the products. You may need to talk with your health care professional and try different inhalers to find the product that is right for you.

For More Information

Metered Dose Inhalers (MDIs)
www.fda.gov/cder/mdi/default.htm

FDA Safety Update: Asthma Medications
www.fda.gov/consumer/updates/asthmameds051308.html

FDA's Web Page on Eliminating Ozone-depleting Substances from Metered-Dose Inhalers
www.fda.gov/cder/mdi/albuterol.htm

Tags: FDA Guidance, FDA Action, Asthma Medication, COPD Medication, Albuterol, Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, Ventolin HFA Inhalation Aerosol, Xopenex HFA Inhalation Aerosol

Pregnancy and Lactation Labeling

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

• The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
• Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
• The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

Tags: Pregnancy, Lactation, prescription drugs Labeling, biological products Labeling

Switch to HFA-Propelled Albuterol Inhalers Now As CFC-propelled inhalers no longer available as of Dec. 31, 2008, FDA!

FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
CFC-propelled inhalers no longer available as of Dec. 31, 2008

The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.

CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

"Concern about the environment stimulated the need to phase out CFCs," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers."

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

Manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now.

HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.

The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of ozone depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, 2008.

For more information:
http://www.fda.gov/cder/mdi/albuterol.htm

Tags: FDA Advisory, Inhalers, albuterol inhalers, Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, Ventolin HFA Inhalation Aerosol, levalbuterol, Xopenex HFA Inhalation Aerosol

Calcilo XD Infant Formula Recalled Worldwide By Abbott. : Recallr

Abbott today announced a voluntary worldwide recall of two lots of Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD® is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order.

Abbott is voluntarily recalling two lots of product because small amounts of air may have entered the can, resulting in product oxidation. A common sign of oxidation is an off aroma. The problem is isolated to these two lots of Calcilo XD Powder in 14.1-ounce (400g) cans.
Recallr: Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder Recalled Worldwide By Abbott.

Tags: FDA Recall, infant product recall, Infant Formula Recall, Calcilo XD Recall, Abbott Recall