Hair-Loss Drug Rogaine OKd for Counter Sales

Balding Americans, take note: The federal government has just made it a little easier to wage war on Mother Nature.

Eight years after approving the first and only known medical treatment for hereditary baldness, the FDA took that action one step further Monday, making Rogaine an over-the-counter drug as easy to obtain from a pharmacy as aspirin.

The move, which reverses an earlier FDA decision, prompted the drug’s manufacturer, Michigan-based Pharmacia & Upjohn Inc., to cut the price of its product in half, to $29.50 for a one-month supply. The company said that it hopes the reduction encourages people to try Rogaine and said that the drug will be on shelves as early as April.

The FDA’s approval was largely welcomed by dermatologists, 10,000 of whom were gathered in Washington this week for the annual meeting of the American Academy of Dermatology. While some expressed concern that consumers would misuse Rogaine, most said the increased availability will be a boon for those suffering from the hereditary condition known as pattern baldness for men or hereditary thinning for women.

“It’s good for the public to have this available to them, to allow it to be at a cheaper price,” said Dr. Wilma F. Bergfeld, a hair loss specialist at the Cleveland Clinic in Ohio. “It’s not a cure-all. Let’s not wish for the moon. But what we are attempting to do is to fight your hereditary tendencies.”

The critical ingredient in Rogaine is minoxidil, a drug that initially was used to lower blood pressure. The over-the-counter product approved Monday by the FDA is a 2% minoxidil formulation. Pharmacia & Upjohn has also asked the agency to approve a 5% minoxidil formula as a prescription drug. That request was made in December.

About 40 million American men and 20 million women experience hair loss or hair thinning at any given time, often because of hereditary factors, a condition known in the medical literature as androgenic alopecia. For years, doctors believed that there was no way to combat what genetics had preordained.

When Rogaine was approved as a prescription drug in 1988, it was heralded as something of a miracle worker. That image quickly ran headlong into reality, however, as consumers discovered that the drug does not reverse hair loss but simply keeps more hair from falling out.

“I think that perhaps the expectations were too high,” said Dr. Vera Price, a dermatology professor at UC San Francisco. “I think it was exciting because, before that, we never dreamed that we would ever be able to reverse something as normal and common as hereditary hair thinning. I, for one, never thought it would be possible.”

Rogaine does not work for everyone. The FDA reports just 25% of men and 20% of women who use the drug experience moderate hair growth, although the drug maker maintains that some patients are satisfied with minimal peach fuzz.

The drug, a clear and odorless liquid that feels like water, is applied to the scalp twice a day, every day, and it can take months to see a difference. Its effectiveness plateaus after one year of use, dermatologists say, and patients who stop using it lose hair again.

“One of the problems,” said Bergfeld, the Cleveland specialist, “is that people poop out.”

Still, annual sales of Rogaine, which is marketed in more than 80 countries, were $122 million in 1994, including $96 million in the United States. Pharmacia & Upjohn estimates that 4 million people have used Rogaine since it was first approved, but company spokesman Jeff Palmer could not say how many people use the product regularly.

It has been nearly three years since Pharmacia & Upjohn first asked the FDA to permit the sale of Rogaine without a prescription. The FDA turned down that request in July 1994, citing questions about the drug’s effectiveness and the difficulty consumers could have understanding its labels.

Because hereditary baldness appears differently in men and women, the FDA was particularly concerned whether patients could appropriately diagnose themselves as candidates for Rogaine.

In a society that places much emphasis on looks, the effectiveness question no longer appears to trouble the FDA.

Said an agency spokesman: “It is effective enough.”