Association wants Delay of iPLEDGE Accutane FDA Program - Acne Drug
linked to Birth Defects
The government approved a system for preventing pregnant women from
taking Accutane. The drug has been linked to miscarriages and severe
birth defects. The American Academy of Dermatology, the largest
dermatological association, has asked the Food and Drug Administration
(FDA) to delay the March 1st implementation date by two months.
The Academy urged the FDA to “postpone” the new iPLEDGE system because
dermatologists across the country are reporting numerous flaws in the
program “that are interfering with patient care and could affect patient
Accutane, and the generic Isotretinoin, has been approved to treat
severe disfiguring acne with great results. According to the New York
Times, the condition afflicts only about 6,000 patients, nearly all of
them male. But the drug is prescribed to more than 170,000 patients, of
which about half are women.
The health risks arise when the drug is prescribed to women that may
become pregnant or who are already pregnant. The federal government has
undertaken more than 40 efforts since 1982, when the drug was approved,
to prevent women from taking the drug while pregnant. The problem
All four of the Isotretinoin / Accutane manufacturers have agreed to
construct a system that requires doctors, pharmacists and patients to
control the drug’s distribution. The fear is that the system may send
patients to the Internet, “where medicines may be counterfeit and there
are no safeguards to prevent pregnancy”, according to Reuters.
The March of Dimes says more than 1,000 women have become pregnant while
using Accutane. March of Dimes is a group working to prevent birth
defects, and has been working for “two decades to improve the inadequate
voluntary programs for regulation of isotretinoin”, according to their
press release. The iPLEDGE program was praised by the March of Dimes
back in August after the program’s announcement was made.
Some dermatologists have already started complying with the program at
the end of last year. Dr. Diane Thiboutot of the American Academy of
Dermatology Association told the FDA "The results today are a disaster.
Pharmacists, prescribers and patients are confused and frustrated."
IPLEDGE supporters insist the March 1st deadline not be changed. The
Public Citizen Advocacy group has worked for two decades in support of
stronger controls on the drug and has said in a January 2006 press
release “almost 25 years after initial marketing and the knowledge of
teratogenicity, there are more restrictions than ever before, but these
are probably still not adequate.”
By Dan Wilson
Best Syndication Staff Writer
Books on Pregnancy
Keywords and misspellings: priatal prenatal pre-natal acutane