Health Panel: Ease Limits on Acne Drug
08/01/2007 Health advisers are urging slightly more flexibility in rules
designed to
prevent pregnancies among women taking an acne drug that has caused birth
defects _
even though women taking the drug still are getting pregnant.
Advisers to the Food and Drug Administration decided Wednesday that minor
changes
would ease access to Accutane and its generic competitors without further
increasing
those troubling pregnancies.

There were 122 pregnancies in the program's first year and another 37 in the
four months
since, administrators of the privately run program told the panel.

The program lost track of 35 of the women who became pregnant. Most of the rest
of the
pregnancies, 54, ended in abortion, and an additional 17 women miscarried. The
one child
known to have been born so far escaped birth defects, and officials are watching
to see
what happens with 15 continuing pregnancies.

Moreover, Accutane's manufacturer learned of another 19 pregnancies in women who
took
the drug despite never enrolling in iPledge _ a program that was supposed to
cover every
user of the drug, every doctor who prescribed it and every pharmacy that sold
it. Women
taking the drug pledged not to become pregnant.

"Why does that not represent a major failure of the iPledge system?" asked
panelist Sean
Hennessy, an assistant professor of epidemiology at the University of
Pennsylvania School
of Medicine.

It's unknown how most of the women obtained the drug, said Dr. Daniel Reshef, of
Accutane manufacturer Hoffmann-La Roche Inc. Two got it from outside the
country, two
directly from pharmacies, one took the drug by accident _ she thought it was
ibuprofen _
and another took her mother's prescription.

The FDA convened the panel of experts to conduct an initial review of the
program meant
to prevent women from becoming pregnant while taking the drug. Exposure to
isotretinoin
_ as the drug is formally known _ in the womb can cause severe brain and heart
defects,
mental retardation and other abnormalities.

In the only vote Wednesday, the 18 panelists agreed unanimously to recommend
making
the program more flexible, something long sought by dermatologists.

For example, they said women who don't fill a prescription within seven days of
a
pregnancy test should be allowed to get another test and then fill the
prescription.
Currently, those who don't act within seven days are frozen out of the program
for 23
days.

In a second change, they said women should have to fill the prescription within
seven days
of a pregnancy test, rather than within seven days of first seeing their doctor.

All patients _ men and women _ who want the drug must enroll in the program,
along with
wholesalers, doctors and pharmacies. Women must meet additional requirements,
including using two forms of birth control (or pledging abstinence) and passing
pregnancy
tests before each monthly refill.

Most of the reported pregnancies appear due to women's failure to back up their
birth
control, or to failure of birth control itself, said Reshef.

The FDA wants more information about those pregnancies to improve the $100
million
program, the most rigorous risk-management program the agency has approved for
any
drug.

But just 10 percent of the 122 women who conceived while taking the drug
provided the
detailed, follow-up information needed to do so, Cynthia Kornegay, of the FDA's
drug risk
evaluation office, told panelists.

Several advisers called the questionnaires punitive in tone. For example, a
question about
a woman's educational background followed others about their experiences with
contraception failure, said adviser Dr. Judith Kramer.

"If that's not implying you're stupid because you're pregnant, I don't know what
it's doing,"
said Kramer, an associate professor at Duke University Medical Center. Panelists
recommended encouraging women upfront to engage in the detailed follow-up should
they become pregnant.

Even further changes to the program may do little to prevent pregnancies: Agency
officials
acknowledged their efforts may be thwarted by a limited ability to change human
behavior.

"The agency is very cognizant of the fact that getting to a zero goal is not
possible to
attain," said Dr. Susan Walker, director of the FDA's dermatology drugs office.

More than 305,000 patients registered to use the drug, including 137,415 women
of
childbearing age. The registry allowed 91,894 of them to receive at least one
prescription.

(This version SUBS 11th graf, In a second..., to CORRECT recommendation to say
seven-
day period should be dated from pregnancy test, sted doctor visit.) )

Last update: 08/01/2007


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