FDA OKs Drug That Can Cause Hair to Grow

The federal government gave approval for the first time Wednesday to an anti-baldness treatment that produced some hair growth in four out of 10 men tested and should be available in drugstores within six weeks.

The prescription drug, known as Rogaine, is the first to gain the endorsement of the Food and Drug Administration for use by the approximately 30 million people in the United States who suffer hair loss. Officials said that it could make a major dent in the lucrative “quack” market of unproven drugs that claim to help hair growth.

The manufacturer, the Upjohn Co. of Kalamazoo, Mich., has not yet set a price for the drug. But in Canada, one of 45 countries in which its sale has been approved, the product sells for the equivalent of about $50 for a month’s supply. A company official said that prices in the United States would likely be comparable.

The drug, sold in the form of a solution, is applied directly to the scalp. For patients who used it twice-daily over a four-month period in clinical studies, “dense” hair growth occurred in about 8% and moderate growth in 31%, officials said. The remaining 61% experienced little or no change.

William Grigg, spokesman for the FDA, said that while the success rate was less than half, “it’s better than any other product out there, none of which has anything but a zero percent success rate. I think some bald men will feel that way, anyway.”

Grigg said that untested and unapproved anti-balding drugs on the market “have been probably the second most active area of quack products, behind diet products, that we’ve had to deal with. . . . And, usually, when a useful, proven product appears, it wipes out the quack market.”

Under review by the FDA for 2 1/2 years, Rogaine is an offshoot of a high-blood pressure drug called Loniten that was first marketed a decade ago and that uses the same active ingredient--minoxidil. When patients using the blood pressure drug reported hair growth as a side effect, researchers began to look at minoxidil’s possible use as a baldness treatment.

Don’t Know Why It Works

While Upjohn believes that the drug will be effective for some men, company spokesman T. R. Reid said that researchers still do not know why it works.

“That’s something we’re still looking into,” he said. “We don’t know the method of action yet.”

An FDA advisory panel recommended final approval of the drug more than 1 1/2 years ago, but agency action has been slowed by concerns over health side effects. Grigg said that the drug can complicate health problems in patients with heart conditions and that those interested in the treatment should have a complete medical review before seeking a prescription.

“A drug of this sort--which is purely cosmetic--had to withstand very severe scrutiny in terms of safety, and that was one of the reasons this took so long to approve,” Grigg said. “But we’re satisfied now that it’s safe if used correctly.”

Reid of Upjohn said that side effects from Rogaine are “very rare,” primarily involving minor dermatologic reactions.

Upjohn officials said they hope to have the drug in pharmacies across the country within four to six weeks. The company is not disclosing its projections of how profitable the treatment may prove. But market analysts have placed its potential annual sales at between $50 million and $250 million.