FDA OKs Tighter Controls for Accutane
'iPLEDGE' Program Aims to Prevent Use of Acne Drug During Pregnancy
Aug. 12, 2005 -- The FDA has approved a plan to help prevent pregnant women
from using the prescription acne drug Accutane and its generic versions.
Isotretinoin (Accutane and its generics) is a highly effective drug, but it
carries a significant risk of birth defects if taken during pregnancy,
according to an FDA news release.
That risk has long been noted on the acne drug's information packets. Now,
drug companies are launching a new program to drive the message home to
doctors, patients, pharmacies, and drug wholesalers.
'Long Overdue' Change?
"This is a system that has been long in the works, and, many would say,
is long overdue," Sandra Kweder, MD, told reporters in a conference call.
Kweder is the deputy director of the Office of New Drugs at the FDA's Center
for Drug Evaluation and Research.
"The responsibilities for ensuring that fetuses are not exposed to this
medicine is enormous and are shared by everyone who participates in
distribution of the drug, or prescribing the drug, or taking the drug,"
Since then, the FDA and all involved drug companies
have been hammering out the details. In November 2004 the drug companies
announced that they had reached an agreement; a plan called iPLEDGE is the
result of those efforts.
About the Program
The iPLEDGE plan requires virtually everyone involved with prescribing,
supplying, or using the drug to register and accept certain
For women of childbearing age, those responsibilities include:
- Signing an informed consent form in their doctor's office.
- Personally registering with iPLEDGE.
- Getting two negative pregnancy tests within seven days of starting the
- Agreeing to use two forms of birth control.
- Getting a negative pregnancy test within seven days of seeking their
monthly drug refill.
The pregnancy tests must be done in a doctor's office or at a lab. Home
pregnancy tests do not count.
Men also have to sign an informed consent form and be registered through
their doctor's office, but they don't need to personally sign up with iPLEDGE
or follow the plan's pregnancy-related rules.
"This is a drug that's taken only for about four to six months,"
Doctors, Patients, Pharmacies Must Register
Doctors, pharmacies, and wholesalers must also register with iPLEDGE and
take on certain duties.
For instance, the prescribing doctor must counsel patients about the drug's
risks, give them an informed consent form, register with iPLEDGE, note patients
taking the drug in the iPLEDGE system, and receive patients' pregnancy test
Pharmacies must log on to iPLEDGE and check that everything is in order
before filling a prescription for the drug for women of childbearing age.
Wholesale companies must agree only to give the drug to pharmacies that
register with iPLEDGE.