Ostomyland's Wicked Wiki : FoodPoisoning

HomePage :: Categories :: PageIndex :: RecentChanges :: RecentlyCommented :: Login/Register
Most recent edit on 2007-11-21 08:16:58 by JasonD [Restored to Original Version by Kathy]

Additions:
~*Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck & Co., Inc. today updated the prescribing information for ROTATEQ? (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program. A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.


Deletions:
alboolodronr
*Merck Updates Prescribing Information For Rotateq®, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck Updates Prescribing Information For Rotateq®, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck & Co., Inc. today updated the prescribing information for ROTATEQ® (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program. A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.




Edited on 2007-11-21 07:48:21 by BocdoMorpa

Additions:
alboolodronr
*Merck Updates Prescribing Information For Rotateq®, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck Updates Prescribing Information For Rotateq®, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck & Co., Inc. today updated the prescribing information for ROTATEQ® (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program. A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.


Deletions:
~*Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck & Co., Inc. today updated the prescribing information for ROTATEQ? (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program. A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.




Edited on 2007-05-21 06:06:37 by KathyFromEngland

Additions:
This cellular cross talk trIgGers a cascade of genetic activations prompting EHEC to colonize and translocate toxins into cells, altering the makeup of the cells and robbing the body of nutrients. An infected person may develop bloody diarrhea or even hemolytic uremic syndrome, which can cause death in immune-weakened people, the elderly and young children.
"The results of this study are important because complicated intra-abdominal infections are typically caused by mixed bacteria and require both surgery or drainage of the infection site and broad-spectrum antibiotic therapy for effective treatment," said Mark Malangoni, M.D., lead study investigator and Professor of Surgery at Case Western Reserve University School of Medicine and Surgeon-in-Chief at MetroHealth Medical Center in Cleveland. "AVELOX has demonstrated potent activity against the bacteria most common in these infections and is a safe and effective treatment. It also can be continued as a once-daily tablet, which is convenient for patients."
Complicated intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue. The bIgGest challenge to effective cIAI treatment is early recognition of the problem; the sooner the infection is diagnosed, the greater the chance that the physician will prescribe an effective treatment.
Cera Products, manufacturers of CeraLyte, an oral therapy which corrects dehydration from diarrhea, reports increased orders for CeraLyte oral rehydration solution (ORS), due to outbreaks of diarrhea (norovirus) in college dormitories, on cruise ships and nursing homes, and from e-coli cases linked to green leafy vegetables in fast food restaurants.
Both norovirus and e-coli are transmitted via the fecal-oral route (through poor handwashing) and, if left untreated, the resulting diarrheal illness can cause severe dehydration, and, sometimes, lead to kidney failure and death. Hydrating a severely dehydrated person with IV hydration in the hospital can cost $2,000 per day, compared to $4 or less per liter of CeraLyte, according Charlene Riikonen, CEO of Cera Products.
A study of CeraLyte to treat children stricken with severe diarrhea (cholera), published in Acta Pediatrica 2001 found that, "This rice-based ORS, with its variety of short, medium and long chain carbohydrates, maximizes absorption of salts and water, reducing diarrheal volume losses."
"CeraLyte is unique because its patented long-chain carbohydrate formula speeds absorption of valuable electrolytes, salts and minerals that match the body's natural composition and losses," says Ms. Riikonen. "CeraLyte should be kept on hand in the medicine cabinet and in travel bags."
Formulated with the help of physicians from Johns Hopkins Hospital, CeraLyte can be ordered online and shipped next day. It is also available through pharmacies, outdoor retailers REI and Dick's Sporting Goods and travel health clinics nationwide, including Passport Health. For information: http://www.ceraproductsinc.com or 1-888-237-2598.
E-coli and Salmonella crisis prompts Zonda Incorporated to introduce QuikAlert(TM), a valuable addition to its food safety product line. QuikAlert(TM) was designed as a first line of defense in detecting food borne pathogens directly from a food product before it is packaged or shipped. Typically, perishable food products are packaged and shipped before pathogen test results are available from the lab. QuikAlert(TM) can detect these potentially dangerous microorganisms in minutes versus hours or days.
QuikAlert(TM) is a fast and easy test to perform. A provided swab is used to sample a food product. After 20 minutes a fluid is added to the tip of the swab. After 2 minutes, a positive test will result in a purple color on the tip of the swab, indicating a presence of potentially dangerous microorganisms. This test will allow growers to check their crops and get results directly in the field before harvest.
QuikAlert(TM) detection of food borne pathogens protects the health of consumers and can save millions of dollars to food growers and food processing companies. QuikAlert(TM) is a screening tool that can deliver these desired results quickly.
Zonda will be featuring QuikAlert(TM) in the exhibition hall at the United Fresh Tech show in Palm Springs, April 27 -28.
The dose-ranging trial was designed to measure levels of an antibody, IgG, that is associated with protection against enterotoxigenic E. coli. Four different doses -- 7.5 micrograms, 22.5 micrograms, 37.5 micrograms and 50 micrograms -- and a placebo patch were tested, and antibody levels were checked at 21 and 42 days. The results showed that nearly all patients in the four dosing groups responded to the vaccine, with even the lowest dose of the vaccine evoking a response in more than 95 percent of patients.


Deletions:
This cellular cross talk triggers a cascade of genetic activations prompting EHEC to colonize and translocate toxins into cells, altering the makeup of the cells and robbing the body of nutrients. An infected person may develop bloody diarrhea or even hemolytic uremic syndrome, which can cause death in immune-weakened people, the elderly and young children.
"The results of this study are important because complicated intra-abdominal infections are typically caused by mixed bacteria and require both surgery or drainage of the infection site and broad-spectrum antibiotic therapy for effective treatment," said Mark Malangoni, M.D., lead study investigator and Professor of Surgery at Case Western Reserve University School of Medicine and Surgeon-in-Chief at MetroHealth Medical Center in Cleveland. "AVELOX has demonstrated potent activity against the bacteria most common in these infections and is a safe and effective treatment. It also can be continued as a once-daily tablet, which is convenient for patients."
Complicated intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue. The biggest challenge to effective cIAI treatment is early recognition of the problem; the sooner the infection is diagnosed, the greater the chance that the physician will prescribe an effective treatment.
Cera Products, manufacturers of CeraLyte, an oral therapy which corrects dehydration from diarrhea, reports increased orders for CeraLyte oral rehydration solution (ORS), due to outbreaks of diarrhea (norovirus) in college dormitories, on cruise ships and nursing homes, and from e-coli cases linked to green leafy vegetables in fast food restaurants.
Both norovirus and e-coli are transmitted via the fecal-oral route (through poor handwashing) and, if left untreated, the resulting diarrheal illness can cause severe dehydration, and, sometimes, lead to kidney failure and death. Hydrating a severely dehydrated person with IV hydration in the hospital can cost $2,000 per day, compared to $4 or less per liter of CeraLyte, according Charlene Riikonen, CEO of Cera Products.
A study of CeraLyte to treat children stricken with severe diarrhea (cholera), published in Acta Pediatrica 2001 found that, "This rice-based ORS, with its variety of short, medium and long chain carbohydrates, maximizes absorption of salts and water, reducing diarrheal volume losses."
"CeraLyte is unique because its patented long-chain carbohydrate formula speeds absorption of valuable electrolytes, salts and minerals that match the body's natural composition and losses," says Ms. Riikonen. "CeraLyte should be kept on hand in the medicine cabinet and in travel bags."
Formulated with the help of physicians from Johns Hopkins Hospital, CeraLyte can be ordered online and shipped next day. It is also available through pharmacies, outdoor retailers REI and Dick's Sporting Goods and travel health clinics nationwide, including Passport Health. For information: http://www.ceraproductsinc.com or 1-888-237-2598.
E-coli and Salmonella crisis prompts Zonda Incorporated to introduce QuikAlert(TM), a valuable addition to its food safety product line. QuikAlert(TM) was designed as a first line of defense in detecting food borne pathogens directly from a food product before it is packaged or shipped. Typically, perishable food products are packaged and shipped before pathogen test results are available from the lab. QuikAlert(TM) can detect these potentially dangerous microorganisms in minutes versus hours or days.
QuikAlert(TM) is a fast and easy test to perform. A provided swab is used to sample a food product. After 20 minutes a fluid is added to the tip of the swab. After 2 minutes, a positive test will result in a purple color on the tip of the swab, indicating a presence of potentially dangerous microorganisms. This test will allow growers to check their crops and get results directly in the field before harvest.
QuikAlert(TM) detection of food borne pathogens protects the health of consumers and can save millions of dollars to food growers and food processing companies. QuikAlert(TM) is a screening tool that can deliver these desired results quickly.
Zonda will be featuring QuikAlert(TM) in the exhibition hall at the United Fresh Tech show in Palm Springs, April 27 -28.
The dose-ranging trial was designed to measure levels of an antibody, IgG, that is associated with protection against enterotoxigenic E. coli. Four different doses -- 7.5 micrograms, 22.5 micrograms, 37.5 micrograms and 50 micrograms -- and a placebo patch were tested, and antibody levels were checked at 21 and 42 days. The results showed that nearly all patients in the four dosing groups responded to the vaccine, with even the lowest dose of the vaccine evoking a response in more than 95 percent of patients.




Edited on 2007-05-21 06:02:45 by KathyFromEngland

Additions:
~*Iomai Dose-Ranging Trial Demonstrates Needle-Free Patch Vaccine For Travelers' Diarrhea Stimulates Immune Response Even At Low Doses
*Simple Equations Track Listeria Trails
Simple Equations Track Listeria Trails
20 May 2007
Circles, slaloms, figure eights, and loop-the-loops - biologists studying the motion of Listeria monocytogenes sensed that these paths were related, but they didn't have a good way to define what fit in and what didn't. A remarkably simple new mathematical description, published online in the Proceedings of the National Academy of Sciences [Abstract], reproduces all these shapes with just one pair of equations and only two key variables. Besides helping to identify bacterial mutants, the equations suggest which mechanisms could be driving the motion.
Last winter, Vivek Shenoy, an associate professor of engineering at Brown University, was matched with Julie Theriot, an associate professor at the Stanford School of Medicine, at a biophysics "boot camp" run by Rob Phillips at the California Institute of Technology. Theriot studies Listeria, a disease-causing bacterium that hijacks the actin network of an infected cell to propel itself. Embedded in a network of actin fibers, the bacterium keeps adding actin molecules at its back end, pushing itself forward and leaving behind an actin tail tracing its path.
Those paths intrigued Shenoy as soon as he saw Theriot's movies of Listeria traveling in the two-dimensional world of a microscope slide. Some bacteria spun in circles, others followed a sine curve, some followed a path like the cloverleaf exchange on a highway. The circles, he thought, were easy to explain. If an actin filament pushed just a bit off center, the bacterium would go in circles, like a swimmer who paddles harder on one side.
With a bit more thought, he cracked the sine curve. What if that off-center point rotated around the axis of motion" When it pushed harder on the right, the bacterium would move to the left; when it pushed to the left of center, the cell would move to the right. If the bacterium moved forward faster than it curved around, a swerving pattern would result.
The clincher came as Shenoy worked out the mathematics to describe this kind of motion. The exact same equation, it turned out, also described the figure-eights, cloverleaves and other looping patterns they had observed. In fact, nearly every time they recorded a new pattern, they found it fit the equation. An equation that can predict observations clearly has a lot going for it, but a mathematical description is not the same thing as a biological mechanism.
"If we can understand things is a simpler setting, such as this one," said Shenoy, "then we can use those insights to study more complex phenomena."
As the team works to fully explain the motion they observe, Shenoy's equations can narrow the possibilities, ruling out mechanisms that cannot generate both the circular and the spinning component of the motion.
With just two variables - an offset distance and an angle relative to the forward motion - they could reproduce every track they saw, except those produced by mutant microbes that Theriot introduced. The mutants stood out as different. They produced a skidding kind of pattern instead of the graceful curves that most of the bacteria traced.
"The human visual cortex is really good at seeing patterns," said Theriot, "but this gives us a quantitative framework for asking questions that before we could only ask qualitatively."
Being able to pinpoint just how different the mutants are is valuable, said Theriot, because they often are less infectious than normal Listeria. Once Listeria invades a host cell, it uses the actin mechanism to move from cell to cell, never again exposing itself to the organism's extracellular immune system. A microbe with a deficient movement mechanism is a microbe with less ability to invade neighboring cells.
http://www.medilexicon.com/medicalnews.php?newsid=71106


Deletions:
~*Iomai Dose-Ranging Trial Demonstrates Needle-Free Patch Vaccine For Travelers' Diarrhea Stimulates Immune Response Even At Low Doses




Edited on 2007-04-27 08:58:26 by KathyFromEngland

Additions:
~*E-coli & Salmonella Crisis Prompts Solution
*Iomai Dose-Ranging Trial Demonstrates Needle-Free Patch Vaccine For Travelers' Diarrhea Stimulates Immune Response Even At Low Doses
Iomai Dose-Ranging Trial Demonstrates Needle-Free Patch Vaccine For Travelers' Diarrhea Stimulates Immune Response Even At Low Doses
27 Apr 2007
Iomai Corporation (Nasdaq: IOMI) today announced results from a 400-patient, Phase 2 dose-ranging trial of its patch-based vaccine for travelers' diarrhea. The trial was conducted to assess the ability of a range of vaccine doses to generate an immune response against enterotoxigenic E. coli (ETEC) bacteria -- the most common cause of travelers' diarrhea. Researchers found that even at the lowest dose tested, an Iomai patch applied to the arm generated a robust response in more than 95 percent of patients.
The results were presented today by Iomai's Vice President of Clinical Development, Sarah A. Frech, DVM, at the Vaccines for Enteric Diseases 2007 conference in Lisbon, Portugal.
"These results demonstrate the power of Iomai's technology by showing that even a small dose of vaccine, applied to the skin via a patch, is enough to stimulate a robust immune response. The data will help us determine the dose that we will use in our ETEC product," said Gregory M. Glenn, MD, Senior Vice President and Chief Scientific Officer of Iomai. "Iomai's research has shown that, in addition to showing potential benefits against ETEC, the active ingredient in the patch also works as an immune-boosting adjuvant when the patch is used in combination with injected vaccines for influenza. Thus, the results from the dose-ranging ETEC study will also help determine doses for future studies of the Iomai booster patch for seasonal and pandemic influenza."
Travelers' diarrhea sickens between 20 and 50 percent of international travelers to areas where the bacteria is endemic, but no ETEC vaccine is available in the United States. The existing strategy for avoiding travelers' diarrhea -- prophylactic antibiotics -- raises concerns about antibiotic resistance and drug side effects.
The dose-ranging trial was designed to measure levels of an antibody, IgG, that is associated with protection against enterotoxigenic E. coli. Four different doses -- 7.5 micrograms, 22.5 micrograms, 37.5 micrograms and 50 micrograms -- and a placebo patch were tested, and antibody levels were checked at 21 and 42 days. The results showed that nearly all patients in the four dosing groups responded to the vaccine, with even the lowest dose of the vaccine evoking a response in more than 95 percent of patients.
Iomai's ETEC vaccine uses "heat labile" toxin, or LT, produced by E. coli, to induce an immune response against the bacteria, and LT also functions as a potent adjuvant in the company's influenza patch programs.
http://www.medilexicon.com/medicalnews.php?newsid=69082


Deletions:
~*E-coli & Salmonella Crisis Prompts Solution




Edited on 2007-03-20 07:46:06 by KathyFromEngland

Additions:
~*Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
*E-coli & Salmonella Crisis Prompts Solution
E-coli & Salmonella Crisis Prompts Solution
20 Mar 2007
E-coli and Salmonella crisis prompts Zonda Incorporated to introduce QuikAlert(TM), a valuable addition to its food safety product line. QuikAlert(TM) was designed as a first line of defense in detecting food borne pathogens directly from a food product before it is packaged or shipped. Typically, perishable food products are packaged and shipped before pathogen test results are available from the lab. QuikAlert(TM) can detect these potentially dangerous microorganisms in minutes versus hours or days.
QuikAlert(TM) is a fast and easy test to perform. A provided swab is used to sample a food product. After 20 minutes a fluid is added to the tip of the swab. After 2 minutes, a positive test will result in a purple color on the tip of the swab, indicating a presence of potentially dangerous microorganisms. This test will allow growers to check their crops and get results directly in the field before harvest.
QuikAlert(TM) detection of food borne pathogens protects the health of consumers and can save millions of dollars to food growers and food processing companies. QuikAlert(TM) is a screening tool that can deliver these desired results quickly.
Zonda will be featuring QuikAlert(TM) in the exhibition hall at the United Fresh Tech show in Palm Springs, April 27 -28.
http://www.medilexicon.com/medicalnews.php?newsid=65558


Deletions:
~*Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children




Edited on 2007-03-19 07:31:44 by KathyFromEngland

Additions:
~*Altered DNA Allows Salmonella To Survive Better In Stomach
*Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
Merck Updates Prescribing Information For Rotateq?, The Company's Vaccine To Help Prevent Rotavirus Gastroenteritis In Infants And Children
19 Mar 2007
Merck & Co., Inc. today updated the prescribing information for ROTATEQ? (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program. A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.
ROTATEQ is approved for the prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3 and G4, and is administered as a three-dose series to infants between the ages of 6 to 32 weeks. Since approval, more than 3.5 million doses of ROTATEQ have been sold.
ROTATEQ was approved based on the results of the landmark Rotavirus Efficacy and Safety Trial (REST), which involved nearly 70,000 infants, about half receiving ROTATEQ and half receiving placebo. REST was specifically designed to evaluate vaccine safety with respect to intussusception. Intussusception occurs when the bowel folds in on itself causing an intestinal blockage. In REST, there was no increased risk of intussuception with ROTATEQ, compared to placebo.
"It is common for post-marketing experience information with a vaccine to be reported to VAERS and for the prescribing information to be updated accordingly," said Mark Feinberg, M.D., Ph.D, vice president of policy, public health and medical affairs, Merck Vaccines. "Merck places public health and patient safety as our highest priorities, and we are very confident in the data supporting the safety profile of ROTATEQ from the placebo-controlled Rotavirus Efficacy and Safety Trial. Merck will continue to work with the FDA and the Centers for Disease Control and Prevention (CDC) to monitor post-marketing experience with ROTATEQ by collecting data from additional systems including active, controlled surveillance studies in addition to passive reporting systems such as VAERS."
The "Adverse Reactions" section of the label for ROTATEQ has also been updated to include information on hematochezia (bloody stools) from the pre-licensure clinical trials. In REST, the rate of hematochezia was comparable between the vaccine and placebo recipients within six weeks following any dose.
VAERS is a national vaccine safety surveillance program cosponsored by the FDA and the CDC. VAERS collects and analyzes information from voluntary reports of adverse events that occur after the administration of licensed vaccines. A report to VAERS does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination. Merck encourages healthcare providers and consumers to report any adverse experience associated with ROTATEQ to the Company and to VAERS.
ROTATEQ is recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP). Among children under five in the United States, it is estimated that 2.7 million episodes of rotavirus gastroenteritis occur each year, with an estimated 250,000 emergency room visits and up to 70,000 hospitalizations.
Selected Safety Information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine. No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination. Over 71,000 infants were evaluated in three placebo-controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of ROTATEQ when compared to 2.6% of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia reported as a serious adverse event for ROTATEQ compared to placebo was <0.1% vs <0.1%. The most frequently reported serious adverse events for ROTATEQ compared to placebo were bronchiolitis (0.6% vs 0.7%), gastroenteritis (0.2% vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1% vs 0.1%), and urinary tract infection (0.1% vs 0.1%).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6% vs 42.8%). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1% vs 21.3%), vomiting (15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis (6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%). In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.
As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.
http://www.medilexicon.com/medicalnews.php?newsid=65481


Deletions:
~*Altered DNA Allows Salmonella To Survive Better In Stomach




Edited on 2007-02-01 15:06:40 by KathyFromEngland

Additions:
~*Norovirus And E-coli Outbreaks: Cera Oral Rehydration Solutions Speed Recovery
*Altered DNA Allows Salmonella To Survive Better In Stomach
Altered DNA Allows Salmonella To Survive Better In Stomach
01 Feb 2007
Since 1995 there has been a considerable increase in the number of infections with a specific type of Salmonella bacteria transmitted via food. This type, Salmonella serovar Typhimurium DT104, is resistant to at least five different antibiotics. Dutch researcher Armand Hermans found new genetic information in DNA of DT104 that might be involved in its survival and infection mechanism. This genetic information might also be involved in the increase in the number of infections caused by this pathogen.
By comparing the DNA of Salmonella serovar Typhimurium DT104 with the known DNA code of another Salmonella strain, Hermans found new DNA fragments in DT104. These pieces of DNA were found to contain genetic information that might play a role in the survival and infectiousness of this pathogen. The presence of such extra genetic characteristics can make the pathogen stronger and more infectious.
To examine how DT104 behaves to survive various "extreme" conditions, the switching on and off of 500 genetic characteristics was studied. This happened under different conditions such as in a hot, acid or oxygen-free environment. Almost all of the survival characteristics were found to be active under all conditions, whereas the pathogenic characteristics were only active under a few of the conditions. Therefore this pathogen always does everything it can to survive under all conditions, for example, during food conservation or in gastric acid. The pathogenic characteristics of DT104 on the other hand are only active in the intestines where the infection takes place.
Evolution of the pathogen
The DNA of the pathogen says something about how it survives and is transmitted. When a pathogen reproduces, the DNA can change a bit and this can lead to changes in the genetic characteristics. This can, for example, lead to antibiotic resistance but also heat or acid resistance. The pathogens with the best genetic characteristics can spread and survive better and are therefore more infectious: the evolution of a pathogen. Examining which genetic characteristics are present in an infectious Salmonella (in this case the DT104 type) can reveal how this pathogen has become stronger and caused more outbreaks. This information can also be used to make a less dangerous variant of this infectious Salmonella. Such a harmless variant can be used as a vaccine.
Salmonella serovar Typhimurium DT104 is an antibiotic-resistant pathogen that is transmitted via food and is considered to be dangerous for humans. In recent decades the number of infections with this variant has increased in many parts of the world. This research was funded by NWO and contributes to knowledge about the characteristics and behaviour of this dangerous Salmonella.
http://www.medilexicon.com/medicalnews.php?newsid=61921


Deletions:
~*Norovirus And E-coli Outbreaks: Cera Oral Rehydration Solutions Speed Recovery




Edited on 2006-12-30 12:50:51 by KathyFromEngland

Additions:
~*Combination Of Technologies Works Best Against E. coli
*Norovirus And E-coli Outbreaks: Cera Oral Rehydration Solutions Speed Recovery
Norovirus And E-coli Outbreaks: Cera Oral Rehydration Solutions Speed Recovery
29 Dec 2006
Cera Products, manufacturers of CeraLyte, an oral therapy which corrects dehydration from diarrhea, reports increased orders for CeraLyte oral rehydration solution (ORS), due to outbreaks of diarrhea (norovirus) in college dormitories, on cruise ships and nursing homes, and from e-coli cases linked to green leafy vegetables in fast food restaurants.
Both norovirus and e-coli are transmitted via the fecal-oral route (through poor handwashing) and, if left untreated, the resulting diarrheal illness can cause severe dehydration, and, sometimes, lead to kidney failure and death. Hydrating a severely dehydrated person with IV hydration in the hospital can cost $2,000 per day, compared to $4 or less per liter of CeraLyte, according Charlene Riikonen, CEO of Cera Products.
Dr. Alan Buchman, gastroenterologist at Northwestern University Hospital explains, "IV hydration can be reduced by timely use of oral rehydration solutions. Adult gastroenterologists and surgeons need to learn the experience with ORS from our pediatric colleagues."
A study of CeraLyte to treat children stricken with severe diarrhea (cholera), published in Acta Pediatrica 2001 found that, "This rice-based ORS, with its variety of short, medium and long chain carbohydrates, maximizes absorption of salts and water, reducing diarrheal volume losses."
"CeraLyte is unique because its patented long-chain carbohydrate formula speeds absorption of valuable electrolytes, salts and minerals that match the body's natural composition and losses," says Ms. Riikonen. "CeraLyte should be kept on hand in the medicine cabinet and in travel bags."
Although oral rehydration is used regularly in Third World countries for diarrheal illnesses, Dr. Nigar S. Shahid, a specialist in diarrheal disease, says, "ORS offers a therapy that is simple, effective and inexpensive with very few potential complications. Yet, this life-saving therapy has been slow to be accepted by Western medicine."
Formulated with the help of physicians from Johns Hopkins Hospital, CeraLyte can be ordered online and shipped next day. It is also available through pharmacies, outdoor retailers REI and Dick's Sporting Goods and travel health clinics nationwide, including Passport Health. For information: http://www.ceraproductsinc.com or 1-888-237-2598.
Based in Columbia, Maryland, Cera Products' pioneering rice-based oral electrolyte blends correct dehydration, restoring fluid volume and cell balance for a variety of medical conditions.
Cera Products, Inc.
http://www.ceraproductsinc.com
http://www.medilexicon.com/medicalnews.php?newsid=59797


Deletions:
~*Combination Of Technologies Works Best Against E. coli




Edited on 2006-12-18 10:53:50 by KathyFromEngland

Additions:
~*Combination Of Technologies Works Best Against E. coli

Combination Of Technologies Works Best Against E. coli
17 Dec 2006
No one weapon in the food-safety arsenal will take out E. coli 0157:H7, a nasty little pathogen that's becoming far too familiar to Americans, say University of Illinois scientists Scott Martin and Hao Feng.
And they should know because they work on this problem in their labs every day. The food science professors work with ozone, high-intensity ultrasound, electrolyzed water, irradiation, and temperature, and they say no treatment singlehandedly can reduce the number of pathogens sufficiently to meet the standards set by the FDA.
"We don't believe there's any one technique out there that's going to be effective," said Martin. "We're constantly trying different combinations to achieve the 5-log (99.999 percent) reduction in the number of organisms required by the FDA," he said.
"Obviously maintaining quality is a real challenge because if you do anything very harsh to something like spinach or lettuce, the product won't be acceptable even if it's pathogen-free," Martin said.
Both scientists believe they're getting closer to a solution. "With ultrasound, we can actually damage the pathogen's cells to the point that they can't be repaired. Ultrasound is a complicated technology, and we're still trying to learn how to use it effectively. But this technology causes physical damage--ruptures in the pathogen's cells--and that's important," said Feng.
In Martin's lab, a graduate student has eliminated all Listeria monocytogenes on a stainless steel chip in 30 seconds, using a combination of ultrasound and ozone. This extremely positive result has promising implications for the sanitation of processing equipment, the scientist said.
And Martin said the scientists have reduced the length of time it takes to reach the FDA's 5-log reduction standard to 30 seconds, which may still be too long for industry. "The thing is we're making steady progress," he said.
And the work goes on. Feng's use of ultrasound, irradiation, and acidic electrolyzed water to eliminate E. coli on alfalfa and broccoli seeds and his use of high-intensity ultrasound to eliminate E. coli in apple cider were published in the February and June 2006 issues of the Journal of Food Science.
Their work on inactivation of E. coli 0157:H7 with peroxyacetic acid, acidic electrolyzed water, and chlorine on cantaloupes and fresh-cut apples was published in the November 2006 article of the Journal of Food Safety.
"We've shown that we have some effective weapons to use against the pathogens that have been in the news so often lately," Martin said. "But we've seen the best results when we've combined the various technologies."
http://www.medilexicon.com/medicalnews.php?newsid=58904


Deletions:
~*Title 3




Edited on 2006-07-29 07:25:45 by KathyFromEngland

Additions:
~*Avelox As Effective As Multi-dose Combination Therapy For Intra-abdominal Infections

Deletions:
~*Title 2



Edited on 2006-07-29 07:25:10 by KathyFromEngland

Additions:
Avelox As Effective As Multi-dose Combination Therapy For Intra-abdominal Infections
28 Jul 2006
Schering-Plough Corporation (NYSE: SGP) today reported that monotherapy with the once-daily, broad-spectrum antibiotic AVELOX (moxifloxacin HCl) was as effective and well tolerated as a standard multi-dose combination antibiotic regimen in the treatment of patients with complicated intra-abdominal infections (cIAI), according to results of a study involving 681 patients published in the current issue of the Annals of Surgery.(1) AVELOX, the only marketed fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) as monotherapy to treat cIAI, was shown to be effective at eradicating the most common bacteria that cause cIAI, including E. coli and B. fragilis.
In the study, patients who took 400 mg once daily of AVELOX intravenous (I.V.) followed by oral monotherapy achieved similar clinical cure rates (80 percent) at the test-of-cure visit (the primary efficacy endpoint) as patients who took a standard regimen of I.V. piperacillin-tazobactam followed by oral amoxicillin-clavulanate (78 percent).
Importantly, AVELOX demonstrated a significantly higher cure rate of 82 percent - compared to 55 percent for the combination therapy - among patients who acquired their cIAI in a hospital setting (including both mild-to-moderate and more severe hospital-acquired infections). Hospital-acquired infections are often caused by more resistant bacteria than community-acquired infections. Clinical cure rates for patients with community-acquired infections were similar between the two treatment groups.
The incidence of adverse events in the study due to any cause was similar for the two treatment groups, with the majority being mild or moderate in nature. The most common adverse events were nausea, hypokalemia, abdominal pain and constipation. The incidence of drug-related serious adverse events or premature discontinuation due to adverse events was similar for the two treatment groups.
"The results of this study are important because complicated intra-abdominal infections are typically caused by mixed bacteria and require both surgery or drainage of the infection site and broad-spectrum antibiotic therapy for effective treatment," said Mark Malangoni, M.D., lead study investigator and Professor of Surgery at Case Western Reserve University School of Medicine and Surgeon-in-Chief at MetroHealth Medical Center in Cleveland. "AVELOX has demonstrated potent activity against the bacteria most common in these infections and is a safe and effective treatment. It also can be continued as a once-daily tablet, which is convenient for patients."
AVELOX is indicated to treat polymicrobial cIAI infections, including infections caused by mixed aerobic and anaerobic bacteria (bacteria that thrive without oxygen) commonly seen in patients with cIAI.
"One fixed dose of AVELOX offers physicians a convenient treatment option with no dose adjustment required as symptoms improve and patients transition from intravenous (hospital-based) to oral therapy," said Joseph S. Solomkin, M.D., Professor in the Department of Surgery and Director of Research of the Division of Trauma/Critical Care at the University of Cincinnati College of Medicine, and a leading expert in the field. "The key benefit of staying with the same agent is the knowledge that the patient responded to it intravenously and can continue with the oral form when they leave the hospital."
Complicated intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue. The biggest challenge to effective cIAI treatment is early recognition of the problem; the sooner the infection is diagnosed, the greater the chance that the physician will prescribe an effective treatment.
In the absence of effective cIAI therapy, treatment failure and mortality rates increase. Clinical practice guidelines recommend that antimicrobial therapy should begin as soon as infection is suspected, before an exact diagnosis is confirmed. There are approximately 3.5 million annual cases of cIAI in the United States.
http://www.medilexicon.com/medicalnews.php?newsid=48101




Edited on 2006-07-27 02:55:32 by KathyFromEngland

Additions:
Categories
CategoryBowelDisease




Edited on 2006-07-26 12:20:12 by KathyFromEngland

Additions:
The new study identifies QseC as the specific receptor by which EHEC senses the signals. When the receptor binds to signaling molecules, the bacterium can infect cells.
Researchers tested the capacity of adrenergic antagonists, drugs such as alpha and beta blockers, to disrupt the receptor's sensing ability. They found that phentolamine binds to the QseC receptor and occupies the pocket that the receptor would use to recognize the host epinephrine and norepinephrine signals - thus blocking the QseC receptor from sensing the signals and preventing it from being able to express its virulence genes in cells.
That importance is magnified because of the QseC receptor's existence in other types of bacteria, including, Shigella, which causes dysentery; Salmonella, which causes food poisoning and gastroenteritis; and Yersinia, which causes bubonic plague. Those are all emerging infectious diseases that afflict thousands of people each year in the United States and worldwide, according to the Centers for Disease Control and Prevention.


Deletions:
The new study identifies QseC as the specific receptor by which EHEC senses the signals. When the receptor binds to signaling molecules, the bacterium can infect cells.
Researchers tested the capacity of adrenergic antagonists, drugs such as alpha and beta blockers, to disrupt the receptor's sensing ability. They found that phentolamine binds to the QseC receptor and occupies the pocket that the receptor would use to recognize the host epinephrine and norepinephrine signals - thus blocking the QseC receptor from sensing the signals and preventing it from being able to express its virulence genes in cells.
That importance is magnified because of the QseC receptor's existence in other types of bacteria, including, Shigella, which causes dysentery; Salmonella, which causes food poisoning and gastroenteritis; and Yersinia, which causes bubonic plague. Those are all emerging infectious diseases that afflict thousands of people each year in the United States and worldwide, according to the Centers for Disease Control and Prevention.




Edited on 2006-07-25 04:26:08 by KathyFromEngland

Additions:
Contents
*Bacteria, Beware: New Finding About E Coli Could Block Infections, Lead To Better Treatments
*Title 2
*Title 3
 
Bacteria, Beware: New Finding About E Coli Could Block Infections, Lead To Better Treatments


Deletions:
Bacteria, Beware: New Finding About E Coli Could Block Infections, Lead To Better Treatments



Edited on 2006-07-24 12:28:14 by KathyFromEngland

Additions:
Researchers at UT Southwestern Medical Center are the first to identify the receptor, known as QseC, used by a diarrhea-causing strain of E coli to receive signals from human flora and hormones in the intestine and express virulence genes to initiate infection.

Deletions:
Researchers at UT Southwestern Medical Center are the first to identify the receptor, known as QseC, used by a diarrhea-causing strain of E coli to receive signals from human flora and hormones in the intestine and express virulence genes to initiate infection.



Edited on 2006-07-24 12:27:27 by KathyFromEngland

Additions:
Bacteria, Beware: New Finding About E Coli Could Block Infections, Lead To Better Treatments



Deletions:
Bacteria, Beware: New Finding About E Coli Could Block Infections, Lead To Better Treatments



Oldest known version of this page was edited on 2006-07-24 12:26:47 by KathyFromEngland []
Page view:

About food poisoning


Bacteria, Beware: New Finding About E Coli Could Block Infections, Lead To Better Treatments
28 Jun 2006

A newly discovered receptor in a strain of Escherichia coli can be blocked to avert infection, a finding that might aid in developing better therapies to treat bacterial infections resulting in food poisoning, diarrhoea or plague.

Researchers at UT Southwestern Medical Center are the first to identify the receptor, known as QseC, used by a diarrhea-causing strain of E coli to receive signals from human flora and hormones in the intestine and express virulence genes to initiate infection.

In a study made available online this week and in an upcoming issue of the Proceedings of the National Academy of Sciences, researchers describe how they used phentolamine, an alpha blocker drug used to treat hypertension, to successfully impede signaling to the receptor. Without such signals, bacteria then pass blindly through the digestive tract without infecting cells.

"This receptor is found in many pathogens, so we can use this knowledge to design specific antagonists to block bacterial infections," said Dr. Vanessa Sperandio, senior author of the study and assistant professor of microbiology at UT Southwestern.

Prior research by Dr. Sperandio found that when a person ingests the more virulent enterohemorrhagic E coli, or EHEC - which is usually transmitted through contaminated food such as raw meat - it travels peacefully through the digestive tract until reaching the intestine. There, however, chemicals produced by the friendly gastrointestinal microbial flora and the human hormones epinephrine and norepinephrine alert the bacteria to its location.

This cellular cross talk triggers a cascade of genetic activations prompting EHEC to colonize and translocate toxins into cells, altering the makeup of the cells and robbing the body of nutrients. An infected person may develop bloody diarrhea or even hemolytic uremic syndrome, which can cause death in immune-weakened people, the elderly and young children.

The new study identifies QseC as the specific receptor by which EHEC senses the signals. When the receptor binds to signaling molecules, the bacterium can infect cells.

Researchers tested the capacity of adrenergic antagonists, drugs such as alpha and beta blockers, to disrupt the receptor's sensing ability. They found that phentolamine binds to the QseC receptor and occupies the pocket that the receptor would use to recognize the host epinephrine and norepinephrine signals - thus blocking the QseC receptor from sensing the signals and preventing it from being able to express its virulence genes in cells.

This knowledge opens the door to further understanding of the signaling processes between microbes and humans and to the development of novel treatments of bacterial infections with antagonists to these signals, Dr. Sperandio said.

New therapies are important because treating some bacterial infections with conventional antibiotics can cause the release of more toxins and may worsen disease outcome.

That importance is magnified because of the QseC receptor's existence in other types of bacteria, including, Shigella, which causes dysentery; Salmonella, which causes food poisoning and gastroenteritis; and Yersinia, which causes bubonic plague. Those are all emerging infectious diseases that afflict thousands of people each year in the United States and worldwide, according to the Centers for Disease Control and Prevention.

"Overuse of antibiotics has led bacteria to develop resistance to antibiotics, so a novel type of therapy is needed," Dr. Sperandio said.

http://www.medilexicon.com/medicalnews.php?newsid=46018
Valid XHTML 1.0 Transitional :: Valid CSS :: Powered by Wikka Wakka Wiki 1.1.6.2
Page was generated in 1.1953 seconds