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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FDA Approves Head Lice Treatment for Children and Adults

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.

“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”

Natroba is a topical drug product and should be applied only to the child’s scalp or hair. The product should be used exactly as prescribed by a health care professional.

The safety and effectiveness of Natroba Topical Suspension 0.9 %, has been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group.

Common adverse events reported include redness or irritation of the eyes and skin.

Safety in pediatric patients below the age of 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.

Natroba is manufactured for ParaPRO LLC of Carmel, Ind.

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