The following alert has been released by the FDA’s MedWatch program.
Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Audience: Pediatric and family practice healthcare professionals, public health professionals
FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA’s recommendation is a precaution taken while the agency learns more about the situation.
FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.
There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.
Additional information, including information for healthcare professionals and parents, is provided in the document below.
Read the complete MedWatch 2010 Safety summary, including a link to the Update statement from FDA, at:
http://www.fda.gov/…/SafetyAlertsforHumanMedicalProducts/ucm205640.htm
Notice that the FDA does not in this instance choose to alert consumers. The problem with that is that many who prescribe this vaccine will fail to see the alert. Too often consumers are kept in the dark about things that affect them by the FDA.
Remember too that stating “PCV1 is not known to cause disease in humans” is not the same as saying it does not cause adverse effects or disease in humans. In a separate notification of this issue the FDA used the phrase “there is no known safety risk” which sounds reassuring but should be viewed as the reverse. Why is it that the FDA, when it comes to regulating drug company products, can get away with testing anything and everything they choose to approve on a trusting population of consumers? Yes, I know they have laws to empower them, but why do people simply accept this scandalous situation? I guess the saying about needing enough ignorant people to form a democracy has some truth in it.
Tags: MedWatch, Rotarix vaccine, vaccine error
Childhood obesity rates have tripled over the past 30 years, with about one in three American children currently overweight or obese, according to government figures. Now Barry Popkin and Carmen Piernas of the University of North Carolina have found in their study that snacks account for about 27 percent of the calories consumed by children, and total daily calorie intake has risen by an average of 113 calories from 1977 to 2006.
The researchers examined data on the eating habits of 31,337 children from four nationally representative surveys of food intake. They found: “The largest increases in snacking events have been in salty snack and candy consumption; however, desserts and sweetened beverages remain the major sources of calories from snacks.” Unfortunately they also found that snacking on fresh fruit has declined significantly compared to the late 1970s. So extra calories are coming from more junk food and less healthy foods.
Popkin and Piernas concluded: “Our findings suggest that children ages 2–18 are experiencing important increases in snacking behavior and are moving toward a consumption pattern of three meals plus three snacks per day. This raises the question of whether the physiological basis for eating is becoming dysregulated, as our children are moving toward constant eating.” (Trends in Snacking Among US Children, Health Affairs. 29, No. 3 (2010): 398–404)
Overweight problems and obesity in childhood constitutes a timebomb in society. If you have children aged 2 to 18 years, don’t wait for others, start defusing it now!
The German arm of BUND, a major environmental group, said BPA traces detected in drinks containers made by major players such as Becks, Fanta and Sprite were within current safety limits and unlikely to pose an independent health risk. However, the group called for the banning of the chemical in food contact materials on the grounds that consumption of canned drinks would add to consumers’ cumulative exposure to BPA.
Dozens of studies have linked BPA to several serious health problems including heart disease, diabetes and birth defects, although agencies such as the European Food Safety Authority (EFSA) and the US Food and Drug Administration (FDA) have approved its use. Of course, these agencies have a track record of approving substances that later prove too harmful or dangerous so approval in itself is no grounds for complacency.
Tests carried out by the laboratory Labor fur Ruckstandsanalkik, of Bremen, found BPA in 11 can linings of the brands examined, with traces of the chemical also discovered in almost half the drinks. Levels per can ranged from 0.3 micrograms (µg) in Nescafé Xpress Vanilla’s container to 8.3µg in Faxe Bier. According to the results, the Coca-Cola can showed 2.6µg, Becks Beer 2.2µg, Red Bull 2.6µg, Xtreme Energy Drink 4.7µg, Rich Energy 4.8µg, Fanta 5.5µg/ and Sprite 6.0µg/can
Traces of BPA were found in five beverages at levels up 3.9µg/litre. The lowest positive level of the chemical was detected at 0.3µg/litre from a can of Sprite, while the highest was in a sample of canned Faxe-Bier. Other positive results saw BPA detected in Red Bull 0.9µg/litre, Nestle Xpress Vanilla drink 1.5µg/litre and 1µg/litre in Schöfferhofer Grapefruit, reported BUND.
No BPA was found in beverage samples tested from Coca-Cola, Fanta, Becks Bier, Rich Prosecco and Xtreme Energy drink.
The group said that factors such as storage conditions of the cans could have influenced the findings and said that more research was needed to determine how significant the results were. This the second recent call from European sources for more research related to BPA. See our recent article concerning the French Food Safety Authority on BPA.
We continue to strongly recommend that you avoid all sources of exposure to BPA.
Tags: bisphenol A, BPA
The March 2010 edition of The Health Gazette Ezine was published as scheduled today. It has been emailed to subscribers and is available in the subscribers’ archive.
In this edition Dr Jenny Tylee provides a brief overview of the special nutritional requirements of those having surgery. Unfortunately many people still need surgery and proper nutritional preparation and followup is very important for achieving best outcomes.
Brief discussion related to some complex hormonal imbalance issues is provided in answer to a reader’s question.
Tags: Health Gazette Ezine, hormonal imbalance, nutrition for surgery
A new study accepted for publication in the International Journal of Food Microbiology predicts an increase in the burden of food-borne disease. The study focussed on the European Union and to a lesser extent the United States and more global issues. Current and potential future trends in technology, consumption and trade of food that may impact on food-borne disease were analysed and the key driving factors identified. These factors come from a wide range of spheres relevant to food and include political, economic, social, technological, regulatory and environmental drivers.
The most important factors driving an increase in the burden of food-borne disease in the next few decades were found to be the anticipated doubling of the global demand for food and of the international trade in food next to a significantly increased consumption of certain high-value food commodities such as meat and poultry and fresh produce. A less important factor potentially increasing the food-borne disease burden would be the increased demand for convenience foods. This may come as a surprise to many people whose only experience with microbiolgical contaminants in food could be stories of gastroenteritis related to some local fast-food outlet.
Factors that may contribute to a reduction in the food-borne disease burden were identified as the ability of governments around the world to take effective regulatory measures as well as the development and use of new food safety technologies and detection methods. The most important factor in reducing the burden of food-borne disease was identified as our ability to first detect and investigate a food safety issue and then to develop effective control measures.
The study deals with issues on a grand scale, recognising the global nature of the food industry. In reality, individuals would do well to restrict consumption of “manufactured foods” or highly processed food products. Eating properly washed and prepared whole foods is much healthier and it eliminates a huge proportion of the risk considered by the study. Of course, growing, storage and transportation conditions all still impact the risk assessment with whole foods, since much “fresh” produce that people consume is grown by other people in sometimes distant places.