FDA OKs Tighter Controls for Accutane
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," says Kweder.
An 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 responsibilities.
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 drug.
- 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," notes Kweder.
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 results.
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.
