Settlement Gets Lead Out of Kaopectate
The makers of Kaopectate agreed Thursday to reformulate all of its popular antidiarrhea products so they no longer contain potentially harmful levels of lead.
A Superior Court judge in San Francisco approved the settlement reached by Pharmacia Corp., California Atty. Gen. Bill Lockyer and an Oakland-based public health group.
In a lawsuit, the state alleged that the company was violating Proposition 65, a 1986 law that requires companies to warn people when they may be exposed to chemicals known to cause cancer or birth defects.
Sold for half a century, Kaopectate is made with attapulgite clay, which naturally contains high levels of lead, a substance that can impair learning development, cause neurological damage to fetuses and children and reduce the fertility of men and women.
Most of the lead has been removed from Kaopecate now being sold, according to company representatives. Some of the older products may still be in homes and on store shelves and should be discarded, a spokesman for the attorney general’s office indicated. Consumers can identify the reformulated versions of Kaopectate by looking for labels that say “new, improved.”
Representatives of Pfizer Inc., which owns Pharmacia, said in a statement Thursday that, “in the interest of avoiding costly and unnecessary litigation,” the company has already reformulated most Kaopectate and that it “expects to complete the process in the near future. The new formula addresses all allegations raised in the litigation.”
Under the settlement, Pharmacia could pay a fine to the state of as much as $1 million. The more lead that is removed, and the faster removal occurs, the less Pharmacia will have to pay.
A few months ago, a little more than a year after Lockyer filed suit, Pharmacia began selling a reformulated version of the medicine in liquid form, eliminating at least 80% of the lead. But the caplets have not been reformulated.
“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 products contained enough lead to pose a health risk,” Lockyer said in a statement after the judge’s ruling.
A single dose of the unreformulated Kaopectate designated for adults contained 240 times as much lead as is considered acceptable under the requirements of Proposition 65, according to tests conducted in 2000 by the Oakland-based environmental organization Center for Environmental Health.
Kaopecate is often given to children, who face the most harmful effects of lead exposure because it can alter their developing brains, impair growth and cause kidney damage. A dose of Children’s Kaopectate had 55 times the acceptable amount. Tests by the attorney general confirmed the high lead levels.
As part of the agreement, said Michael Green, executive director of the Center for Environmental Health, the products will be reformulated nationally.
Lockyer’s office sued Pharmacia in 2001, after the Center for Environmental Health filed its own suit.
“Some of these products, including Children’s Kaopectate, will have more than 95% of their lead removed, and that protects families,” Green said.
No warning signs or labels are required for the new products.
The state’s lawsuits against other defendants that sold lead-containing diarrhea medicine, including Rite Aid, Walgreens, Hi-Tech Pharmacal and Columbia Laboratories, have not been resolved.
None of the companies, however, currently sell the high-lead products in California, according to a spokesman for the attorney general’s office.
Environmental groups that wrote Proposition 65 say the idea was not to besiege California consumers with warning signs, but to pressure manufacturers to alter their products to reduce exposure to toxic substances. Under the law, private groups or people can sue companies but they must first notify the attorney general to see if the state wants to prosecute the case. Proposition 65 was overwhelmingly approved by California voters.
