Group claims companies hide high lead levels in medications

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Group claims companies hide high lead levels in medications

COLLEEN VALLES, Associated Press Writer

Thursday, March 1, 2001

©2001 Associated Press

(03-01) 14:34 PST SAN FRANCISCO (AP) -- 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 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

Green.

-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.

©2001 Associated Press