FDA Issues Retin-A Warning

The Food and Drug Administration warned consumers Tuesday against the indiscriminate use of the anti-acne cream Retin-A as a treatment for wrinkles.

The drug safety agency also cautioned against counterfeit versions of the drug and said it would be cracking down on unlicensed makers of the cream who are advertising and distributing watered-down imitations.

“Retin-A has not undergone proper long-term testing for use as a wrinkle cream, and the present formulation is known to cause some adverse local effects such as severe swelling and peeling,” FDA Commissioner Frank Young said in a statement.

“Use of all these products amounts to an expensive therapeutic gamble,” Young said.

Unethical Pharmacists

Young said some unethical pharmacists, dermatologists and manufacturers were promoting and selling mixtures called Retin-A that actually contain different amounts of the active ingredient, retinoic acid.

Some manufacturers, he also said, are making bogus creams sold as Retin-A or as look-alike products that contain no retinoic acid. Of the latter, Young said, “These are generally sold as cosmetics and, like the other products, can be very expensive.”

The genuine Retin-A is made by Ortho Pharmaceutical Corp. of Raritan, N.J., a subsidiary of Johnson & Johnson. The drug has been approved by the government for marketing solely as an acne treatment, but federal law permits doctors leeway to prescribe drugs as they see fit once a drug is on the market.

Retin-A became an overnight sensation as an anti-wrinkle cream earlier this year after publication of a research article in the Jan. 22 Journal of the American Medical Assn. The article said the drug, a relative of Vitamin A whose chemical name is tretinoin, had been found in a study of 30 individuals to reverse photoaging, the premature aging of the skin due to excessive exposure to sunlight.

The study said the drug may also be of help in reversing the effects of aging on the skin.

Accepted ‘as Gospel’

“Unfortunately, consumers have apparently accepted the reports of this one small study as gospel and are willing to gamble with Retin-A and imitation products sold through the mail or in clinics,” Young said.

“Even some dermatologists are jumping on the bandwagon by offering ‘own label’ products to their patients at exorbitant prices,” he said.

The FDA said it was “actively investigating a number of firms” promoting and selling wrinkle creams.

It said it was working with state authorities, the U.S. Customs Service, the Postal Service and the Federal Trade Commission and would take regulatory action when warranted “to curb the proliferation of illegal versions of Retin-A.”