Local diarrhea drug gets FDA nod

Tampa's Romark Laboratories can now market Alinia in the U.S. It treats the condition in kids.

By KATHRYN WEXLER, Times Staff Writer
© St. Petersburg Times
published December 3, 2002

TAMPA -- A new drug developed by a Tampa company to treat children's diarrhea caused by contaminated water soon will be available in the United States.

The medication, called Alinia, is the first to gain federal approval for killing the parasite cryptosporidium. It also fights the more common parasite, giardia. Both thrive in fecal matter and are transmitted through contaminated water and dirty swimming pools.

Waterborne parasites account for only a small portion of diarrhea in children and adults. But parasitic infections present the most persistent cases, sometimes lasting weeks. They can lead to dehydration, malnutrition and even death.

"It's a big public health problem in the United States," said Marc Ayers, president and CEO of Romark Laboratories, which developed the drug.

With Alinia, "we have high cure rates," Ayers said.

Waterborne illness is on the rise nationally and is a major health hazard in Third World countries. Florida had the most outbreaks in the country, according to a recent study by the Centers for Disease Control and Prevention. The main culprits were wells, pools, hot tubs and water parks.

Babies' leaky diapers often contaminate pool water. Runoff containing animal waste has been blamed on contamination of wells. Chlorine can kill the organisms, but only at high doses, Ayers said.

Unlike over-the-counter remedies that suppress symptoms of diarrhea but do not cure the illness, Alinia apparently blocks enzymes that feed parasites in the digestive tract.

"It's like pulling the spark plugs on a car," Ayers said.

It's highly unusual for the Food and Drug Administration to clear a new drug for children before it has been okayed for adults to use. But the agency said Romark Laboratories proved the liquid kids' version of its drug worked before it provided similar proof for adult-strength Alinia tablets.

Alinia for children will be available by prescription in pharmacies beginning in February.

Nationally, there are fewer than 200,000 reported cases of the parasites annually, according to the FDA.

Cryptosporidium is commonly found in developing countries, but the CDC estimates it causes up to 4,000 infections a year in the United States. The biggest outbreak, in 1993, killed 100 people and sickened 400,000 when cryptosporidium contaminated Milwaukee's water supply.

Still, diarrhea is usually caused by sources other than the parasites.

"It may not become a blockbuster product, but from a health standpoint, it is very important," said Jean-Francois Rossignol, Romark's chairman and chief scientist.

Thiru Arasu, a pediatric gastroenterologist at Tampa Children's Hospital at St. Joseph's, said cryptosporidium is most often seen in children with compromised immune systems due to diseases such as cancer or HIV. The effectiveness of Alinia, or nitazoxanide, has not yet been established in those patients, according to the FDA.

But until now, there has been no cure whatsoever for the parasite.

"If you have crypto, you don't have anything" to prescribe, Arasu said. "So it is a medicine that is needed."

Flagyl, a cure for giardia, has been on the market for decades. The makers of Alinia say it is a good alternative because it requires a shorter oral regimen of three days. Alinia will also be the only FDA-approved drug for giardia in a liquid form for children, ages 12 months to 11 years.

Reported side effects were not significantly different from children receiving placebos, according to Romark. They included abdominal pain, diarrhea, vomiting and headaches.

Alinia is the first drug produced by Romark that will be available in the United States. The company has been marketing Alinia in Latin America for six years, Ayers said. The medicine may eventually be available for adults, he said.

Illnesses involving diarrhea are the second leading cause of death worldwide.

Hillsborough County issued a warning last week about bacteria in the county's drinking water supply in October. Bacterial contamination of water is more common than parasitic contamination and more easily remedied through disinfection.

-- Information from the Associated Press was used in this report. Kathryn Wexler can be reached at wexler@sptimes.com or (813) 226-3383.

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