Government Approves Use of Anti-Baldness Formula
KALAMAZOO, Mich. (AP) _ The first anti-baldness drug that has received federal approval for sales will reach stores within six weeks, but a consumer publication is questioning the substance’s effectiveness.
Upjohn Co. announced the U.S. Food and Drug Administration’s approval of presecription sales of Rogaine on Wednesday.
″We’re very pleased,″ said Lawrence C. Hoff, president and chief operating officer for the Kalamazoo-based company. ″The development of Rogaine represents the first large-scale scientific study of a pharmaceutical agent for hair growth.″
In Washington, FDA spokesman Bill Grigg confirmed late Wednesday that the agency had approved use of Rogaine. The FDA allowed Upjohn to make the announcement at the company’s request, Grigg said.
Upjohn said it has tested Rogaine on about 2,300 balding individuals at 27 medical centers. It said 39 percent of those who twice-daily applied the 2 percent minoxidil solution experienced either dense or moderate hair growth.
The formula will reach stores within six weeks. Price hasn’t been determined, the company said. Rogaine is available in 44 countries, including Canada and Mexico.
Despite approval, Rogaine’s effectiveness has been questioned by Consumer Reports magazine.
The independent consumer magazine, in its September issue, said Upjohn’s tests may exaggerate how well bald spots respond to the formula.
″The study excluded men who were very bald, those with hair only on the sides and a smooth, ‘billiard ball,’ appearance on top,″ the magazine said.
While a small portion of participants did see some regrowth of hair and a shrinking of their bald spots, no one grew back a full head of hair, Consumer Reports said.
Company officials said Rogaine won’t work for everyone, adding that continued use for up to four months is necessary before hair growth can be noticed.
″Because Rogaine is a treatment not a cure, cessation of Rogaine treatment in patients with hair growth will lead to the loss of the hair within a few months,″ said Richard DeVillez, director of dermatology at Upjohn.
Upjohn said it will continue to conduct tests on the effectiveness of Rogaine.
″Because it’s a first, it’s important to us to monitor and analyze its use and acceptance in the medical community. To do this we will be conducting a postmarketing surveillance survey,″ Hoff said.