Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Associated Press - December 2, 2002
The drug treats diarrhea caused by cryptosporidium, a parasite spread by human and animal waste most common in developing countries but that the Centers for Disease Control and Prevention estimates causes up to 4,000 infections a year in the U.S.
The biggest outbreak, in 1993, killed 100 people and sickened 400,000 when cryptosporidium contaminated Milwaukee's water supply.
The drug apparently works by blocking enzyme reactions essential for these parasites to thrive inside people.
It's highly unusual for the Food and Drug Administration to clear a new drug for children before it has been approved for adult usage. But the agency said manufacturer Romark Laboratories proved the liquid kids' version of Alinia worked before it provided similar proof for adult-strength tablets.
Alinia, known chemically as nitazoxanide, also treats a similar waterborne parasite, called giardia. There is an adult treatment for giardia infections, but Alinia becomes the first U.S. therapy specifically for children.
The drug apparently works by blocking enzyme reactions essential for these parasites to thrive inside people.
The chlorine that kills most germs in water doesn't kill cryptosporidium -- it must be filtered out. In addition to drinking water, the bug also can contaminate swimming pools, mostly because of children's diaper leaks. Most healthy people will be well on their way to recovery before a doctor's visit and lab tests diagnose cryptosporidium so they could take Alinia, said Dr. Dennis Juranek, a CDC senior scientist.
But in some people, particularly those with weak immune systems, the infection can be life-threatening -- and having a drug available in the midst of a large outbreak could be very important, he said.
The FDA cautioned that study of children with the AIDS virus found no benefit from three days of Alinia. HIV patients may need longer treatment or higher doses, but it will take more study to determine that, said the FDA's Dr. Renata Albrecht.
Despite that caveat, Alinia's approval is exciting, Dr. Juranek said. "There have literally been hundreds of drugs tried and none seemed to work at all, so to find one that works even in certain circumstances is important," he said.
Alinia was studied in 95 children infected with cryptosporidium in Zambia and Egypt. The drug proved 56% and 88% effective, respectively, in alleviating the diarrhea. The drug was less effective in the Zambian study because those children were malnourished, FDA said.
In a study of 110 children infected with giardia in Peru, Alinia proved 85% effective. Alinia seems to have no serious side effects, but the FDA cautioned that it has been studied only in several hundred children so far.
The prescription-only drug will reach pharmacies in February. Tampa, Fla.-based Romark wouldn't reveal the price.
Company president Marc Ayers said Romark hopes to sell Alinia tablets for adults next year as well, after completing an additional study that the FDA ordered to be sure they work.
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