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To Ban Use Of Derivative In Products

September 6, 1993

WASHINGTON (AP) _ The Food and Drug Administration says it will ban the use of live yeast cell derivative in over-the-counter hemorrhoidal products in a year.

Two studies submitted by manufacturers had failed to demonstrate that the ingredient was effective in treating hemorrhoids, said the agency, as part of a review of non-prescription drugs.

Live yeast cell derivative is among the ingredients in some hemorrhoidal products that claim to treat symptoms of pain, itching, burning or irritation and to shrink the swelling of hemorrhoidal tissues.

But the FDA regards it as effective only as a wound-healing agent.

Among the products affected by the new rule, published in the Federal Register last Thursday, are Preparation H, Formulation R and Prompt Relief, the FDA said.

The manufacturers will have to drop anti-hemorroidal claims attributed specifically to live yeast cell derivative and reformulate the product using proven ingredients, the FDA said.

The FDA also announced a ban in six months on claims that over-the-counter topical antifungals can fight fungal infections of the scalp and fingernails.

The agency said scalp and nail fungus is hard to treat with topical drugs because of the depth of the hair roots and thickness of the nails.

The products affected include Fungi-Nail, Pro Clearz and Lee’s Anti-Fungal Nail Treatment.

The agency also proposed formally recognizing docusate salts as safe and effective ingredients in nonprescription laxatives.

They have long been used in laxatives, but in 1985 some questions were raised about the possibility that docusate sodium might be linked to birth defects in animals.

The FDA said it was now convinced docusate salts are safe. They come in three forms - docusate calcium and docusate sodium for oral use, and docusate potassium for rectal use.

More than 50 products contain docusate salts, including Colace, Correctol, Dialose, Doxidan, Doxinate and Feen-a-Mint.

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