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Group claims high lead levels in medications hidden

The Associated Press
Friday March 02, 2001



SAN FRANCISCO — A health watchdog group plans to sue some manufacturers of over-the-counter anti-diarrheal drugs because it says they contain high levels of lead, and no warning of those levels on their packages. 

The Oakland-based Center for Environmental Health charges the companies are violating Proposition 65, a California law that requires manufacturers to label their products when they knowingly expose residents to certain levels of toxic chemicals, including lead. 

Lead is listed by the state as a carcinogen, and can cause reproductive damage, brain damage and behavioral problems in children. 

The group filed suit Thursday in San Francisco Superior Court against Pharmacia Corp., the maker of Kaopectate, and plans to notify at least 11 other manufacturers that it intends to sue them. 

The CEH is seeking to have the companies reduce the levels of lead in their products and label them so consumers know how much lead is in them. A judge agreed to hear a bid for a preliminary injunction the group also filed Thursday, seeking to have the companies label their products in the meantime. 

“We’re hoping they will do the right thing and come clean to consumers about the lead in their products,” said Katie Silberman of CEH. “There’s no reason there should be lead in medicine.” 

The allowable amount of lead for these medicines is 0.5 micrograms before a warning label must be put on the package. 

According to the CEH, children’s Kaopectate contains 27.9 micrograms of lead, which is more than 55 times the 0.5 level. The maximum dosage for one day is seven two-tablespoon servings, which amounts to more than 195 micrograms of lead. That’s almost 400 times the recommended limit. 

“That’s a serious amount of lead,” said CEH executive director Michael Green. 

Mary-Fran Faraji, the director of public affairs for New Jersey-based Pharmacia, said the company had not seen the complaint yet, but was confident in the safety of the product. She said the active ingredient, the mineral attapulgite, is recognized as safe by the Food and Drug Administration. 

“It’s safe when used as directed,” she said. “We of course are going to look very seriously at this; we just don’t have the details yet.” 

The level at which a warning about lead has to be put on the package was set by Proposition 65, which was passed in 1986. That level is based on exposures that could subject a person taking the medication to a risk of birth defects or reproductive damage. 

But the law is conservative, said Allan Hirsch, a spokesman with the state Office of Environmental Health Hazard Assessment. 

“The way Proposition 65 is written, the maximum allowable daily level would have to be at a level at which even if a person were exposed to 1,000 times that, that there would be no observable effects,” he said. 

The manufacturers to receive a notice of intent to sue include Columbia Laboratories, Walgreen Company, Wyeth-Ayerst Pharmaceuticals, American Procurement and Logistics Co., Perrigo Co., Procter & Gamble, Kmart Corp., Longs Drug Stores, Dayton Hudson Corp., McNeil Consumer Healthcare and Safeway Inc.