THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Tuesday, February 13, 1996 TAG: 9602130251
SECTION: FRONT PAGE: A1 EDITION: FINAL
SOURCE: BY LAURAN NEERGAARD, ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium: 73 lines
Balding Americans will be able to buy the hair-growth drug Rogaine by spring without stopping to see a doctor first.
The Food and Drug Administration decided Monday that Rogaine can be sold in drugstores alongside shampoos and hair colorings, making it the only medically proven drug to fight baldness available without a prescription.
But while the move means people can buy a little hope against hair loss for about $30 a month, the FDA warned that not everybody should.
About 40 million men and 20 million women suffer hair loss, most the hereditary form commonly known as male pattern balding. This is the only type of hair loss that can be alleviated by Rogaine, which has been sold by prescription since 1988.
Even for those people, however, Rogaine doesn't always work, said FDA spokeswoman Ivy Kupec. It helps about 25 percent of male users and 20 percent of women to very gradually grow back moderate amounts of hair, mostly on the very top of the head.
They must keep using Rogaine indefinitely to keep the new hair.
Some experts warned the FDA in November that Rogaine sold over the counter would be overused by desperate consumers who refused to admit it's not helping their particular hair loss.
So how long should people try Rogaine?
``We recommend people try it for four months, but we actually had people in clinical studies who took longer than that,'' said Dr. Joann Data of manufacturer Pharmacia & Upjohn.
People should try Rogaine only if hair loss runs in their family and isn't a sudden or patchy type that might come from an endocrine imbalance, infection, pregnancy or such hairstyles as tight braids, Data said.
If people use Rogaine for the wrong type of hair loss, ``it won't exacerbate the balding they do have,'' she said. ``But say they have a fungal infection, it would prolong the time to diagnosis and appropriate treatment.''
Pharmacia & Upjohn said it will sell nonprescription Rogaine for about half the price of the identical prescription version, $29.50 for a month's supply.
Sales will begin in April, with packages formulated as Rogaine for Men and Rogaine for Women to provide gender-based instructions and illustrations that show whether using Rogaine is appropriate and how to apply it to the scalp.
The FDA's decision comes at a vital time for the Kalamazoo, Mich.-based company. The patent on Rogaine, with annual U.S. sales totaling $96 million, expires today, and a generic manufacturer was poised to begin selling a competitor. Pharmacia asked the FDA Monday for three extra years of marketing exclusivity, under a little-known law that gives such a bonus when companies do extra research to prove a prescription product is safe to use over the counter. The FDA hasn't made a decision.
Rogaine, known chemically as minoxidil, is not for use by anyone under age 18, the FDA and manufacturer emphasized. Some doctors told the FDA in November that they feared parents would seek Rogaine prescriptions when they didn't think their children's hair was growing fast or thick enough.
Side effects are mainly skin irritation and itching. But people should see a doctor if they develop chest pain, rapid heart beat, faintness, weight gain or swollen hands or feet, Kupec said. ILLUSTRATION: FDA APPROVES SALE
40 million men and 20 million women suffer hair loss.
Rogaine can be effective if hair loss runs in the user's family and
isn't a sudden or patchy type, as from infection, pregnancy or
certain hairstyles. It is not for anyone under age 18.
Sales will begin in April; a month's supply will cost $29.50, about
half the prescription cost.
KEYWORDS: ROGAINE HAIR LOSS BALDNESS FDA by CNB