The Associated Press

Addressing a potential health threat in a product millions of parents have given their children, the maker of the anti-diarrhea medicine Kaopectate agreed to slash its lead levels in a settlement with the state approved Thursday.

The medicine's older formula no longer on pharmacy shelves as liquid but still sold in caplet form contains 25 micrograms of lead in every adult dose, or 50 times the level at which California requires a warning label.

Environmentalists, consumer groups and state Attorney General Bill Lockyer called the settlement a victory for children, who can suffer brain damage even from low levels of lead.

"Hundreds of thousands of consumers in California and across the country, including pregnant women and children, ingested Kaopectate and generic versions for years without knowing the product contained enough lead to pose a health risk," Lockyer said.

Pharmacia, the maker of Kaopectate, said in a written statement that its product "has been used safely and effectively for close to 50 years," and that it entered into the settlement "in the interest of avoiding costly and unnecessary litigation."

Pharmacia which was bought in April by New York-based Pfizer Inc. owes $1 million in civil penalties under the settlement, approved Thursday by San Francisco Superior Court Judge Richard Kramer. It will end up paying much less if it moves quickly to remove as much as 95 percent of the lead from Kaopectate, the nation's largest-selling diarrhea remedy.

Pharmacia began reformulating Kaopectate when California sued in 2001. About 80 percent of the lead has been removed from Kaopectate liquid, now sold in an hourglass-shaped bottle with a label that boasts it as "new and improved." Kaopectate caplets have not yet been reformulated.

The key ingredient in Kaopectate had been a substance called attapulgite clay that contains large amounts of lead. Pharmacia has agreed to completely remove the attapulgite from its product and replace it with bizmuth subsalicylate, found in the competing product Pepto-Bismol.

Even in relatively small doses, lead has been found to cause brain damage and other problems in children and neurological damage to fetuses.

A study published in April in the New England Journal of Medicine found a 7.4-point IQ difference between children with just a slightly elevated level of lead in their blood and children with almost none.

"Numerous, small, little tiny doses of lead are much more important than we once thought," said Rick Maas, director of the Environmental Quality Institute at University of North Carolina, Asheville. "Over the last 15 years, we have been gradually uncovering the truth that lower and lower levels of lead exposure can cause irreversible damage, particularly to children and infants."

Lockyer and the Center for Environmental Health sued Pharmacia under a state law that requires manufacturers to provide "clear and reasonable" warning if their products contain certain toxic material.

The law requires a warning label if it exposes a consumer to more than 1/2 micrograms of lead per day. The older Kaopectate formula sold without a warning label contains 25 micrograms in each adult dose and six to 12 micrograms in each child dose.

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