Women using a popular acne drug that causes
birth defects need better information about how to keep from getting pregnant,
a small study suggests.
Isotretinoin – first marketed as Accutane –
is one of the most effective treatments for acne. But isotretinoin is known to
lead to severe birth defects. A programme known as iPledge is aimed at preventing
pregnancies among the drug's users.
The iPledge programme hasn't been very
successful, however, and the new study suggests it should focus on highly
effective birth control methods. "What we found is that people need a clear
message about what birth control would be most effective, and currently the
iPledge materials don't make it clear to most women who enrol in the programme,"
Dr Eleanor Bimla Schwarz said.
Schwarz is the study's senior author and the
director of the Women's Health Services Research Unit of the Centre for
Research on Health Care at the University of Pittsburgh. iPledge was created by
the US Food and Drug Administration and requires women taking the drug to
review educational materials, complete tests and pledge to use two forms of
The programme and previous initiatives to
prevent pregnancies among women taking the drug, however, have had limited or
no success, according to past studies. About 122 pregnancies in women using
isotretinoin were still reported the year after iPledge began in 2006, write
Schwarz and her colleagues in JAMA Dermatology.
Not using birth control
For the new study, the researchers
recruited 16 female isotretinoin users between the ages of 17 and 34 years old
from Pittsburgh. Thirteen women said they used the Pill or a contraceptive ring
as their primary form of birth control.
Others abstained from sex while on the
medication and one reported not using any form of birth control. Some of the
participants said they received brief or no pregnancy prevention counselling
before starting treatment with isotretinoin.
Most of the women also reported having
limited knowledge about intrauterine devices (IUDs) and sub dermal
contraceptive implants. Those, however, are known to be more effective at
preventing pregnancy than the Pill and condoms. IUDs are inserted into the
uterus, where they release small amounts of either copper or the hormone
progestin to prevent pregnancy for up to five or 10 years, depending on the
The contraceptive skin implant, about the
size of a matchstick, is inserted under the skin of the arm, where it releases
controlled amounts of progestin for up to three years. In 2011, the American
College of Obstetricians and Gynaecologists said IUDs and implants should be offered
as birth control options to women, because they are safe and effective.
"Women who are being prescribed
isotretinoin need more information on IUDs and implants to protect themselves
from pregnancy that may be adversely affected by the medication," Schwarz
told Reuters Health. Some of the participants were also surprised that they
could have gotten an IUD or implant instead of using the Pill and using condoms
every time they had sex.
Part of the iPledge programme
Although the researchers say the women agreed
information on IUDs and sub dermal implants should be part of the iPledge
programme, 11 of the women reported being satisfied with their original counselling.
In an accompanying editorial, Dr Emily Altman wrote that it may not be possible
for dermatologists to assess all of a woman's risk factors for every birth
But it's possible to refer patients to an
obstetrician/gynaecologist for evaluation and counselling. "I do that quite
often," Altman, a dermatologist with the Summit Medical Group in Berkeley
Heights, New Jersey, told Reuters Health.
"The point is to communicate with the
patient that these are the methods and these are the risks of getting
pregnant," Altman said. "The choice you have to make is how adherent
you're going to be to each method."
"I think if a woman is sexually active
and she needs good information on proper birth control methods, it's an
excellent idea for an ob-gyn colleague to work with you to make sure that the
patient is safe," she said. A spokesperson for the FDA told Reuters Health
in an email that the agency cannot comment on this specific study and the
validity of the statements.