FDA approves baldness pill
December 22, 1997
Web posted at: 10:06 p.m. EST (0306 GMT)
WASHINGTON (CNN) -- The U.S. Food and Drug Administration on Monday approved a pill designed to help men stop losing their hair and even helps hair grow back.
Propecia, a lower-dose form of a prostate medication, may be available by prescription from Merck and Co. as early as
mid-January, the company said.
Men treated with the daily pill reported they not only stopped losing hair but also grew more.
"This is real hair. This is not fuzz," said Dr. Vera Price, a dermatology professor at the University of California at San Francisco. "About two-thirds of men treated with Propecia showed increased hair growth after two years."
Patients will pay between $45 and $49 a month for a Propecia prescription, Merck officials estimated. Some analysts already are predicting sales of $1 billion in five years.
Researchers, physicians optimistic
"From what I've seen, it works pretty well," said Dr. William Cox, a hair transplant surgeon who has treated patients with a stronger form of Propecia known as Proscar. "It maintains hair and probably grows some hair back."
Researchers said the drug, known generically as finasteride, worked in most men tested.
In one study, 83 percent of men taking Propecia had the same amount of hair or more hair after two years, while 72 percent on a placebo had less hair, said Dr. Keith Kaufman, senior director of Merck Research Laboratories.
In another study involving more than 300 men, half reported improved appearance and more hair, compared to about a third who were taking a placebo.
The only other drug treatment available to fight men's hair loss is Upjohn Inc.'s Rogaine, a lotion known generically as minoxidil, which works for about 40 percent of users.
Some men who took Propecia once a day reported they stopped losing hair after about three months and noticed new hair after six months, said Dr. Ken Washenik of New York University Medical Center.
Side effects of Propecia, including a diminished sexual drive and difficulty achieving erection, occurred in fewer than 2 percent of patients, according to Merck. The FDA also described side effects as infrequent.
Results, with caveats
The drug doesn't appear to work for men who are completely bald, or on areas that are as "bald as a baby's bottom," Price said. It's also not clear whether the pill is effective on men who lose hair from the temples.
Also, the effects appear to wear off when patients stop taking the drug.
"In order to keep any advances that you gain you will have to continue to take it," Price said.
The drug should not be prescribed to women because it can cause birth defects in male fetuses, Price said.
"Women who are pregnant or who may be pregnant should not even handle the tablets if they are crushed or broken," Price said. But, she added, men who took the drug posed no risks to women.
Propecia works against the hormone testosterone. It stops testosterone from converting to dihydrotestosterone, or DHT, which scientists think can work gradually to make hair follicles smaller. Men born with naturally low levels of DHT rarely lose their hair.
Merck discovered Propecia might work when it found men taking the company's prostate medication Proscar were growing hair.
Senior Medical Correspondent Dan Rutz and Reuters contributed to this report.