The FDA has approved Alinia (nitazoxanide) for Oral Suspension to treat diarrhea caused by two parasitic infections--cryptosporidiosis and giardiasis--in children ages 1 through 11. Alinia is the first drug approved specifically to treat cryptosporidiosis, and it's the only drug in suspension form that is approved to treat giardiasis in this age group.
Cryptosporidiosis, an illness caused by the protozoan Cryptosporidium parvum, is characterized by diarrhea, abdominal cramps, loss of appetite, low-grade fever, nausea, and vomiting. Infected people may experience no symptoms, acute diarrhea, or persistent diarrhea that may continue for several weeks. The disease can be prolonged or life-threatening in severely immunocompromised people, and has been associated with malnutrition, impaired growth, and death in children in developing countries. Giardiasis, caused by the protozoan Giardia lamblia, is characterized by diarrhea, abdominal cramps, bloating, weight loss, or malabsorption. Giardiasis has also been associated with impaired growth in children in developing countries.
To date, the safety and effectiveness of Alinia has not been established in people who are HIV-positive or immunodeficient. In studies of children not infected with HIV, the most frequent problems reported in association with Alinia for Oral Suspension were mild, and included abdominal pain, diarrhea, vomiting, and headache.
Alinia is marketed by Romark Laboratories of Tampa, Fla.
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COPYRIGHT 2004 Gale Group
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