NEW YORK (Reuters Health) - 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 program known as iPledge is aimed at preventing pregnancies among the drug’s users.
The iPledge program 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 enroll in the program,” 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 Center for Research on Health Care at the University of Pittsburgh.
iPledge was created by the U.S. Food and Drug Administration and requires women taking the drug to review educational materials, complete tests and pledge to use two forms of birth control.
The program 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.
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 counseling before starting treatment with isotretinoin.
Most of the women also reported having limited knowledge about intrauterine devices (IUDs) and subdermal 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 device. 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 Gynecologists said IUDs and implants should be offered as birth control options to women, because they are safe and effective (see Reuters Health story of June 21, 2011 here: reut.rs/1fmY8uI.)
“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.
Although the researchers say the women agreed information on IUDs and subdermal implants should be part of the iPledge program, 11 of the women reported being satisfied with their original counseling.
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 control option. But it’s possible to refer patients to an obstetrician/gynecologist for evaluation and counseling.
“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.