Ponders Propecia Approval
BETHESDA, Maryland -- A U.S. Food and Drug Administration committee raised questions about the long-term side effects of the world's first pill for hair loss.
The committee was considering the one-a-day pill known as Propecia, and on Thursday questioned whether it does prevent further hair loss. But it was not asked to make a recommendation about the drug.
The committee is expected to make comment about the drug, and the FDA will review those comments and other material before deciding whether to approve the drug. If approved, it could be available by the end of the year.
Propecia is a lower-dose formulation of the drug Proscar -- known generically as finasteride -- marketed by Merck & Co. Inc. to treat prostate problems.
Merck discovered that Propecia might address hair loss after men who were taking Proscar began growing hair. Follow-up studies found that a diluted version of Proscar stopped hair loss or caused new hair to grow in twice as many men as those taking a placebo.
"From what I've seen, it works pretty well," says Dr. William Cox, a physician who specializes in hair transplants. "It maintains hair and probably grows some hair back."
Committee member Dr. James Kilpatrick Jr., of the Medical College of Virginia, said, "I've been very impressed" by studies on Propecia.
A phase III clinical trial showed that, among more than 300 men tested, 52 percent grew more hair when they took Propecia.
An earlier trial of 1,500 men with top-of-the-head thinning found 48 percent grew more hair. After a year, men taking Propecia gained on average 107 new hairs in a one-inch circle.
Not a miracle drug
Propecia is not a miracle pill -- nobody grew a full head of hair and not everybody was helped. But before-and-after photographs showed Propecia helped bald spots shrink, some by very small amounts, but some to where just a quarter-sized spot of scalp still showed.
Hairdresser Troy Satterfield said Propecia helped fill in his thinning crown.
"It's definitely starting to fill in more -- more hair growing in, but just very recently. I think it's taken several months just to start to take effect."
Dr. Cox agreed. "You're probably going to have to take it six months before you see very much change, as far as growing hair," he said. "I think you probably have to think in terms of at least three months to even stem losses of hair."
Men and women gradually lose some hair as they get older. The American Hair Loss Council in Chicago estimates that in the United States more than 33 million men and more than 19 million women suffer hair loss.
The only drug treatment available for hair loss is Upjohn's Rogaine (minoxidil), which is rubbed into the scalp.
Rogaine works in about 40 percent of users, but has side-effects ranging from fluid retention to irregular heartbeat.
FDA concerned about effect on young men
FDA dermatologic drug chief Dr. Michael Weintraub said his main concern is whether it is safe for young men to take for years a pill that affects hormones, merely to fight hair loss. Merck studied balding men ages 18 to 40.
Merck claims that serious side-effects already would have emerged in the millions of older men who take doses five times higher to shrink enlarged prostates.
Finasteride blocks an enzyme that converts testosterone into the related hormone dihydrotestosterone, or DHT, which is know to shrink hair follicles.
Merck's scientists claim they have extra measure of assurance that their product is safe after studies of men born with a rare disease that depletes their DHT. Not only do these men never go bald, they also don't get enlarged prostates or prostate cancer, suggesting a possible protective effect.
Finasteride does have some drawbacks, however. Nearly two percent of the men in various trials of the drug said they suffered a loss of sex drive -- but 1.3 percent of the men getting a dummy pill did, too.
Another 1.3 percent reported erectile dysfunction. There was also some concern among committee members that Propecia might hide early signs of prostate cancer.
Drug hazardous to women of childbearing age
The drug also cause birth defects in women, which is why Merck is seeking approval to sell it by prescription to men only. Although Merck has begun testing in postmenopausal women who don't have that concern, no one knows if their hormones will allow Propecia to work.
There is an added wrinkle to Propecia: Merck insisted that those involve in its studies use the same shampoo to ensure that hair care didn't alter the studies. As a result, the panel insists that Propecia be labeled as effective when used with Neutrogena T-Gel shampoo.