TUESDAY, Dec. 3, 2002 (HealthDayNews) -- The drug Alinia (nitazoxanide) has been given the go-ahead for the treatment of childhood diarrhea and other symptoms caused by two types of parasites.
The parasitic infections, cryptosporidiosis and giardiasis, are often spread through contact with, or ingestion of, contaminated water. Approved for use in children up to age 11, Alinia prevents enzyme reactions that are necessary for the parasites to survive.
In clinical trials, the The U.S. Food and Drug Administration said that Alinia proved up to 88 percent effective in treating symptoms of the infections, which, besides diarrhea, could include abdominal cramps, low-grade fever, nausea and vomiting. The infections are fairly common in developing countries, though the U.S. Centers for Disease Control and Prevention estimates 4,000 Americans may be infected with cryptosporidiosis.
For people with weakened immune systems, either infection could become life-threatening, the FDA says. While clinical trials proved the drug's effectiveness in children, there was little or inconclusive data among adults, particularly those with AIDS-causing HIV, the agency says. More testing among adults and AIDS patients is required, the FDA adds.
It is fairly rare for the FDA to approve a medication for use in children before it approves the drug for adults, experts say. Alinia is manufactured by Romark Laboratories of Tampa, Fla.
Here is the FDA Talk Paper describing Alinia. For more about cryptosporidiosis and giardiasis, visit the Centers for Disease Control and Prevention.
