Originally created 08/30/97

FDA moves to ban laxative ingredient



WASHINGTON (AP) - The government announced today that it intends to ban an ingredient used in over-the-counter laxatives for more than 90 years because of a possible link to cancer.

The Food and Drug Administration acknowledged that it has no reports that the compound called phenolphthalein - one of the ingredients in the popular laxative Ex-Lax - has caused cancer in people.

But studies found high doses of phenolphthalein can cause a variety of tumors in laboratory rats and mice, and some mouse studies also uncovered genetic damage.

The FDA, noting that Americans have access to more than two dozen laxative products that do not contain phenolphthalein, concluded that the worrisome animal data outweighed consumers' need for the product.

So it proposed banning any over-the-counter sale of phenolphthalein, a move that would force Ex-Lax and a host of store-brand laxatives to be reformulated or be taken off the market.

Companies and the public may comment on the proposed ban for 30 days and then the FDA will decide whether to make the ban final.

Ex-Lax maker Novartis Consumer Health Inc. said that phenolphthalein is safe when used as directed for occasional constipation and not frequent use. But "we'll certainly be looking very closely" at the FDA's proposal, said spokeswoman Mary-Frances Faraji.

Several Ex-Lax competitors, anticipating a ban, already have reformulated their laxatives. Bayer Corp. this summer pulled off the market its one laxative brand that contained the ingredient.

The FDA advised consumers today to read the labels of over-the-counter laxatives to see whether they contain phenolphthalein.

A committee of cancer experts consulted by the FDA decided that phenolphthalein could potentially cause cancer in humans. The experts reviewed data showing rats and mice fed doses of phenolphthalein that were approximately 50 to 100 times the recommended dose for humans developed a variety of tumors. Another study by the National Toxicology Program found doses 30 times higher than humans take developed lymphomas.