Tretinoin (Retin-A), and FDA-approved drug for treating acne, has given new hope to consumers searching for the ever-elusive Fountain of Youth. The topical drug, manufactured by Ortho Pharmaceutical Corp., of Raritan, N.J., has recently been reported to reverse premature wrinkling of the skin due to sun damage (photo-aging). But FDA cautions that any benefits may come at the cost of side effects and serious long-term risks.
According to a report in the Jan. 22, 1988, Journal of the American Medical Association, all 30 patients in a study by Jonathan Weiss, M.D., and his colleagues at the University of Michigan Medical Center in Ann Arbor showed significant improvements in sun-related skin aging on their forearms treated with Retin-A, as compared with forearms treated with a drug-free cream. The scientists also reported at least slight overall improvement in 14 of 15 patients who used the drug on their faces.
Retin-A is not approved for treating skin aging, but clinical trials of the drug’s safety and effectiveness for this purpose are being conducted by Ortho and will be evaluated by FDA when the company submits a new drug application for this additional use. Although doctors can prescribe an approved drug for an unapproved use, many doctors and patients prefer not to use a drug until it has been approved for a new use.
FDA Commissioner Frank E. Young, M.D., Ph.D., cautions that no drug is without side effects. Tretinoin can cause redness, blistering, severe local swelling, and peeling in some patients. Current labeling of the drug also warns that long-term animal studies to determine the carcinogenic (cancer-causing) potential of tretinoin have not been performed and that studies in mice suggest that the drug might accelerate the risk of cancer from ultraviolet radiation. In addition, tretinoin is a compound derived from vitamin A. Other vitamin A-derived drugs and large doses of vitamin A itself have been associated with birth defects, although birth defects are not known to be a problem with vitamin A creams.