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A San Francisco judge approved a settlement Thursday requiring the makers of Kaopectate to reduce the levels of lead in its popular liquid anti-diarrheal medicine by 80-to-90 percent.
Superior Court Judge Richard Kramer approved the settlement between Attorney General Bill Lockyer and Pharmacia, which was acquired by Pfizer in April.
Kaopectate is the largest-selling anti-diarrheal with an attapulgite clay-based formula, according to the California Department of Justice. Attapulgite clay contains high levels of lead, which has been linked to cancer and reproductive harm.
"Kaopectate has been used safely and effectively for close to 50 years," said Bryant Haskins, Pfizer spokesman, in a prepared statement Thursday. "In the interest of avoiding costly and unnecessary litigation, Pharmacia already has reformulated the majority of its Kaopectate products -- including all Kaopectate liquid -- and expects to complete the process in the near future."
In November 2001, the California attorney general's office had filed a lawsuit against Pharmacia and various drug stores and distributors alleging that Kaopectate had unsafe levels of lead in violation of Proposition 65.
Proposition 65 requires businesses with 10 or more employees to warn people if their property or product will expose anyone to one of hundreds of chemicals known to the state to cause cancer, birth defects or other reproductive harm.
In a prepared statement Thursday, Lockyer said that "hundreds of thousands of consumers in California and across the county -- including pregnant women and children -- ingested Kaopectate and generic versions for years without knowing the products contained enough lead to pose a health risk."
Pharmacia could owe California up to $1 million in fines, but that figure could be reduced depending on how quickly and how much the company reduces the levels of lead.
"While civil penalties are built into the agreement as an incentive to complete the reformulation process on an expedited basis, Pharmacia anticipates that any penalties will be minimal, based on the company's progress to date," Bryant said.
Since the lawsuit was filed, Pharmacia has removed 80 percent of the lead from the liquid version. But some of bottles with higher lead content still remain in stores, said Tom Dresslar, spokesman for the attorney general's office.
Bottles with the reformulated liquid are labeled "New, Improved." Pharmacia also manufactures Kaopectate in caplet form, which has not been reformulated. Those pill packages will have warning labels.
Proposition 65 is a right-to-know law, according to Allan Hirsch, deputy director in the Office of Environmental Health Hazard Assessment.
"No one really knows what companies may have quietly reformulated their products without being sued or putting out press releases," Hirsch said. "It's kind of a hidden benefit that can't be quantified."
Since Proposition 65 was enacted in 1986, lawsuits have been settled involving typing correction fluid, lead in china and arsenic in bottled water, Hirsch said. There is also pending litigation involving notifying consumers of the level of mercury in fish.
Defendant Lil' Drug Store, which also settled Thursday, formerly distributed a small amount of one anti-diarrheal product that contained attapulgite clay. But after the complaint was filed, it stopped distributing the product in California in December 2001. Under the settlement, it was fined $2,500.
Lil' Drug Store officials were not available for comment.
Settlements have not been reached with other defendants named in the suit, including Rite Aid, Walgreens, Hi-Tech Pharmacal and Columbia Laboratories. Negotiations are ongoing, but none of the defendants is shipping, distributing or selling high-lead attapulgite anti-diarrheal products in California, the state justice department said.
"This case proves how valuable Proposition 65 can be in protecting public health," said Michael Green, executive director of the state's Center for Environmental Health.
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