FDA Clears First Test for Recent Infection With Toxoplasmosis Parasite

/PRNewswire/ -- On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, sometimes known as cat scratch disease, developed the infection within the past four months.

Toxoplasmosis is caused by the parasite Toxoplasma gondii. The infection can cause serious health problems in people with compromised immune systems. Women who become infected just before or during pregnancy may pass the parasite on to their unborn child, resulting in miscarriage, stillbirth, or an abnormally small or large head. Infection can also lead to vision loss, mental disability, seizures or other health problems later in life for the child.

Cats are most often associated with the parasite, but many other species of animals and birds also serve as hosts. The parasite also is found in people worldwide. Common symptoms of toxoplasmosis include swollen lymph nodes and flu-like symptoms.

Toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness, according to the Centers for Disease Control and Prevention. More than 60 million people in the United States may be infected with Toxoplasma gondii. The parasite may be transmitted to people when they eat raw, undercooked or contaminated meat or come in contact with infected cat feces or litter.

The VIDAS TOXO IgG Avidity assay can be used to rule out recent Toxoplasma gondii infection. The test works by detecting how strongly IgG avidity antibodies bind to the Toxoplasma gondii antigens in the assay. IgG avidity antibodies from infections older than four months bind tightly with the antigens, while IgG avidity antibodies from infections acquired in the past four months form weaker bonds.

"Toxoplasmosis can have serious and lasting health consequences for infants that acquire the infection in the womb," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA's Center for Devices and Radiological Health. "This test gives doctors an additional tool to determine if women with confirmed cases of toxoplasmosis acquired the infection before or during pregnancy."

The VIDAS TOXO IgG Avidity Assay test is for use in people who have been confirmed with the Toxoplasma gondii infection by using the VIDAS TOXO IgG II test and who are pregnant or have swollen lymph glands. The VIDAS TOXO IgG Avidity Assay test alone should not be used as a basis for clinical decisions.

The performance of the VIDAS TOXO IgG Avidity Assay has not been established for prenatal screening, for immunocompromised patients, or for cases of toxoplasmosis reinfection or relapse, and the FDA has not cleared or approved the VIDAS TOXO IgG Avidity Assay for blood or plasma donor screening.

The VIDAS TOXO IgG Avidity assay is manufactured by bioMerieux Inc. of Hazelwood, Mo.

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Study Links Fluoride to Pre-term Birth and Anemia in Pregnancy

/PRNewswire/ -- Fluoride avoidance reduced anemia in pregnant women, decreased pre-term births and enhanced babies' birth-weight, concludes leading fluoride expert, AK Susheela and colleagues, in a study published in Current Science (May 2010). http://www.fluorideandfluorosis.com/Anemia/Current%20Science%20Reprint.pdf

Susheela's team explains that anemia in pregnancy, which can lead to maternal and infant mortality, continues to plague many countries despite nutritional counseling and maternal iron and folic acid supplementation. This is the first examination of fluoride as an additional risk factor for anemia and low-birth-weight babies.

Anemic pregnant women living in India, whose urine contained 1 mg/L fluoride or more, were separated into two groups. The experimental group avoided fluoride in water, food and other sources and ate a nutritious diet per instruction. The control group received no instructions. Both groups supplemented with iron and folic acid.

Results reveal that anemia was reduced and pre-term and low-birth-weight babies were considerably fewer in the fluoride-avoidance group as compared to the control. Two stillbirths occurred in the control group, none in the experimental group.

Susheela et al. writes, "Maternal and child under-nutrition and anemia is not necessarily due to insufficient food intake but because of the derangement of nutrient absorption due to damage caused to GI (gastrointestinal) mucosa by ingestion of undesired chemical substances, viz. fluoride through food, water and other sources."

Fluoride avoidance regenerated the intestinal lining which enhanced the absorption of nutrients as evidenced by the reduction in urinary fluoride followed by rise in hemoglobin levels, they report.

Could the same thing be happening in the United States? State University of New York researchers found more premature births in fluoridated than non-fluoridated upstate New York communities, according to a presentation made at the 2009 American Public Health Association's annual meeting.

Previous published research shows fluoride can interfere with the reproductive system (http://www.fluoridealert.org/health/repro).

Current Science reports that adverse reactions of fluoride consumption are known to occur including reducing red blood cells, reducing blood folic acid activity, inhibiting vitamin B12 production and the nonabsorption of nutrients for hemoglobin biosynthesis.

"Citizens must demand that water fluoridation be stopped," says attorney Paul Beeber, President, New York State Coalition Opposed to Fluoridation, Inc. "It's disturbing that public-health officials and organized dentistry continue to ignore the overwhelming evidence revealing fluoride to be non-nutritive, unnecessary and unsafe," says Beeber.

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Study Says Pregnant Women Are More Severely Impacted by Novel H1N1 Influenza Virus

Pregnant women infected with 2009 novel H1N1 had a higher rate of hospitalization and greater risk of death than the general population due to the H1N1 flu, according to a study in the Aug. 8 issue of the British medical journal Lancet.

The data collected and analyzed by the Centers for Disease Control and Prevention (CDC) are the most comprehensive available to date on the impact of this novel H1N1 flu virus among pregnant women.

"The death of a pregnant woman is always heartbreaking, and unfortunately we have been hearing reports of otherwise healthy women dying from H1N1. If a pregnant woman feels like she may have influenza, she needs to call her healthcare provider right away," said CDC’s Dr. Denise Jamieson, lead author of the study. “Clinicians who treat pregnant women should have a system in place for triaging pregnant women with influenza-like symptoms and they should not delay in initiating appropriate antiviral therapy. Some clinicians hesitate treating pregnant women with antiviral medications because of concerns for the developing fetus, but this is the wrong approach. It is critical that pregnant women, in particular, be treated promptly. "

Six deaths of pregnant women with H1N1 were reported to CDC between April 15 and June 16, 2009, representing 13 percent of the total 45 deaths reported to CDC during that time period. All were healthy prior to infection of H1N1 and subsequently developed primary viral pneumonia leading to acute respiratory distress requiring mechanical ventilation. All pregnant women who died did not receive antivirals soon enough to benefit their treatment. CDC recommends that pregnant women with suspected or confirmed influenza infection receive prompt treatment with antiviral medication.

Based on past influenza pandemics and on seasonal influenza epidemics, pregnant women have increased rates of illness and death from influenza infection.

Despite recommendations from the Advisory Committee on Immunization Practices and the American College of Obstetricians and Gynecologists for inactivated flu vaccine for all pregnant women, seasonal flu vaccine coverage among pregnant women is very low (less than 14 percent).

CDC has posted clinical guidance for treatment and prophylaxis of pregnant women with suspected or confirmed pandemic H1N1 2009 influenza at http://www.cdc.gov.h1n1flu/clinician_pregnant.htm.
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New Data Show Drinking While Pregnant Still a Problem

The number of women who drink alcohol while pregnant is not decreasing, according to a 15 year-study by the Centers for Disease Control and Prevention. Approximately 1 in 8 women drank any amount of alcohol while pregnant, the study says.

The drinking patterns persisted despite repeated warnings from surgeons general about the dangers of drinking alcohol while pregnant. The surgeons general have told pregnant women, and women who may become pregnant to abstain from alcohol consumption in order to eliminate the chance of giving birth to a baby with alcohol related birth defects.

The CDC analysis, as well as a study also published today by the U.S. Substance Abuse and Mental Health Services Administration shows that far too many women use substances (especially alcohol) during their pregnancies.

The CDC study, “Alcohol Use Among Women of Childbearing Age, United States, 1991-2005,” is in the CDC′s Morbidity and Mortality Weekly Report.

The CDC study also found that 1 of every 50 pregnant women engaged in binge drinking each year during the 15 years.

“Exposure to alcohol can cause lifelong physical and mental disabilities that are preventable by avoiding alcoholic drinks while pregnant,” said Edwin Trevathan, director of the CDC′s National Center on Birth Defects and Developmental Disabilities. “All women should know that there is no known safe amount of alcohol to drink or safe time to drink it during pregnancy. We encourage all women to pay attention to the surgeon general warnings.”

The study found that pregnant women most likely to report any alcohol use were 35-44 years of age (17.7 percent), college graduates (14.4 percent), employed (13.7 percent), and unmarried (13.4 percent). Pregnant women who binge drink were more likely to be employed and unmarried than were pregnant women who did not binge drink. This study did not examine the reasons why women are still drinking while pregnant.

Any alcohol use was defined as at least one drink of any alcoholic beverage in the past 30 days. Binge drinking was defined as having five or more drinks on at least one occasion in the past 30 days.

“By screening and advising women about the risks of drinking while pregnant, health care providers can play a key role in reducing rates of fetal alcohol syndrome,” said Clark Denny, a CDC epidemiologist and primary author of the study. “This study revealed that there is still a great need for health care professionals to routinely ask all women who are pregnant or at risk of being pregnant about their alcohol consumption.”

The study examined data from 533,506 women aged 18-44 years, of whom 22,027 reported being pregnant at the time of the interview. The data were obtained from the Behavioral Risk Factor Surveillance System (BRFSS). The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventive health practices, and health care access primarily related to chronic disease and injury. Data are collected monthly in all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and Guam.

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