Advertisement

Keep Rogaine a Prescription Drug, Panel Says : Medicine: Committee fears patients will waste money without guidance on baldness medicine.

Share via
From Associated Press

A drug to fight baldness should not be sold without a prescription, a scientific advisory panel told government regulators Wednesday.

The Upjohn Co. is seeking permission from the Food and Drug Administration to sell Rogaine, the hair growth medicine, over the counter.

But an FDA advisory committee recommended against the move, saying that so few people benefit from Rogaine that wider availability would merely encourage the general public to waste its money. The FDA is not bound by advisory committee decisions but usually follows them.

Advertisement

“There’s a tremendous investment of patient time, energy and money, and the committee was concerned that people would not have realistic expectations” without a doctor’s guidance, said committee chairman Randy P. Juhl, dean of the pharmacy school at the University of Pittsburgh.

He also said people who do benefit from Rogaine do better when under a doctor’s care. One trial showed hair growth in 26% of men who used Rogaine that way, compared to 11% of men who didn’t have a doctor’s supervision.

“The effectiveness seen in clinical trials may not hold if the patients aren’t seeing a doctor,” Juhl said.

Advertisement

Upjohn is “disappointed” with the recommendation, said Dr. Joann L. Data, a company vice president. “But the final outcome will be made by the agency.”

Upjohn officials presented extensive studies Wednesday showing Rogaine has been used safely by 3.8 million people worldwide, even if patients have other medical conditions.

Rogaine, or minoxidil, is now on the market as a prescription drug for inherited pattern baldness in men and women. Patients spray the medicine onto the scalp twice daily.

Advertisement
Advertisement