Too Hard To Take: A Strict New Acne Drug Program May Prevent Birth Defects. But Many Complain It Also Drives People Away From a Potentially Life-Transforming Treatment
Article in today’s Washington Post — Too Hard To Take: A Strict New Acne Drug Program May Prevent Birth Defects. But Many Complain It Also Drives People Away From a Potentially Life-Transforming Treatment, by Sandra G. Boodman:
Virtually no one opposes the goal of the mandatory new federal program governing the
use of Accutane: to prevent pregnant women from taking the potent acne drug, approved
in 1982, because it causes serious birth defects.
That is where the consensus about the unusually restrictive six-month-old program known
as iPledge ends. The program requires registration of all parties: wholesalers who sell it,
pharmacists who dispense it, doctors who prescribe it and, above all, patients who take
the drug.
Public health officials say such strict regulation is necessary because years of progressively
stronger voluntary programs failed to prevent pregnancy in users of the medicine, a
treatment of last resort for severe scarring acne. Most of the estimated 200,000 Americans
who take the drug generically known as isotretinoin each year are under 30; half are female.