FDA Approves Pill to Fight Male Baldness


The Food and Drug Administration on Monday approved the first-ever pill to fight baldness, providing another rare weapon for man’s seemingly endless battle against hair loss.

The new pill, called Propecia, is manufactured by Merck & Co. of West Point, Pa., and is expected to cost about $45 a month. It will be available by prescription in mid-January.

It helps male pattern baldness only--promoting hair growth mostly on the top of the head and the front mid-scalp areas. “This is real hair,” Dr. Vera Price, a dermatology professor at UC San Francisco, said at a news conference set up by the company. “This is not fuzz.”

Among men who take the pill but fail to grow new hair, it likely will at least stop hair loss, the company said.

It does nothing for men who are totally bald.

“For most men, Propecia increases the number of scalp hairs, helping to fill in thin or balding areas,” the company said. “Although results will vary, generally you will not be able to grow back all of the hair you have lost.”


The drug is taken once a day. The FDA and the company stressed that taking more of the drug will not result in more hair growth.

“Propecia will not work faster or better if you take it more than once a day,” the company said.

The drug is the first non-topical alternative to Rogaine, an ointment that must be applied directly to the scalp. Once available only by prescription, Rogaine now can be purchased over the counter and helps about 25% of men and 20% of women who use it, according to the FDA.

There are more than 30 million American men who suffer from balding, a result of the aging process. People trying to stem or reverse the process--including millions of women--spend $800 million a year in this country and $1 billion worldwide.

Propecia is not approved for women because it can cause birth defects. In fact, they should not even handle crushed or broken tablets if they are pregnant or potentially could be pregnant, the FDA said. The tablets have a special coating to prevent contact with the active ingredient, but it affords protection only if the tablets remain intact, the company said.

It also is not for use by children.

The drug can have some undesirable side effects on men as well, the FDA said. A small number of men--about 2% of those studied--experienced loss of sexual desire and inability to achieve an erection.

The drug’s active ingredient, finasteride, has been used in higher doses in a drug called Proscar to treat prostate enlargement. Its potential as a baldness therapy was noticed when some prostate patients began regrowing hair on their head.

The drug works by changing the action of a hormone linked to male pattern baldness, a condition that typically begins to afflict men in their 20s. The drug inhibits the conversion of testosterone to dihydrotestosterone (DHT), which is believed responsible for this frequently occurring type of hair loss.

“It is the first treatment to target this key factor” in patients genetically predisposed to this type of baldness, known as androgenetic alopecia, said Dr. Keith Kaufman, senior director for clinical research for Merck Research Laboratories in Rahway, N.J.

The drug can affect the results of a blood test, known as Prostate-Specific Antigen, which is a screening test for prostate cancer. Patients who undergo the test should tell their physicians they are taking the drug, the company said.

Approval of the drug was based on data from three one-year, double-blind placebo-controlled trials involving 1,879 men ages 18 to 41 with mild to moderate hair loss of the vertex (top of the head) and anterior (front) mid-scalp areas. Of these men, 1,215 who had hair loss at the vertex were studied for an additional year.

Hair count increased during the first year and was maintained for most men taking the drug for 24 months; men in the placebo group continued to show progressive hair loss, the company said.

In another analysis, independent dermatologists studied photos of 508 patients after 24 months of treatment. There was an increase in hair growth in 66% of those who took the drug, compared to 7% of men taking the placebo, the company said.

If a patient stops taking the drug, he will likely lose the hair he has gained within 12 months, the company said. Also, men may need to take it daily for three months or more before seeing a benefit. If the drug hasn’t produced any hair growth within 12 months, further treatment is unlikely to be of any benefit.

The American Hair Loss Council, based in Chicago, noted that the new pill is the latest addition to a long line of efforts to combat baldness. “Before Rogaine, hair transplants and hair additions, men coped in various ways--from magic ointments to the styling of their hair. Julius Caesar grew his hair long in the back and combed it all forward; Napoleon did the same thing.”

At least one group, Bald-Headed Men of America in Morehead, N.C., served notice that its members will not be standing in line to purchase the newest remedy in the hair-loss field.

“We’re not going to lose another hair over Propecia. It is fashionable to be bald and proud. . . . Skin is in, and bald men are now making headway,” said John T. Capps III, the group’s founder.