FRIDAY, Aug. 17, 2001 (HealthDayNews) -- Many women don't understand the significance of a graphic on Accutane's label warning them not to get pregnant while taking the acne medication, a new study says.
The graphic is a red circle with a slash through it -- the
universal "No" sign -- superimposed over the silhouette of a pregnant woman. But the study says that more than 25 percent of a small group of women thought the graphic meant that Accutane was a form of birth control, and only one-fifth understood the warning.
An accompanying study notes that approximately 2,000 women using Accutane have become pregnant since the drug was first introduced almost 20 years ago.
Accutane is considered a wonder drug for people with severe, face-scarring acne. But it is also highly teratogenic, meaning it causes birth defects in fetuses that are exposed to the chemical. The deformities are so severe -- affecting the brain, heart and face structure -- that many doctors recommend an immediate abortion for women who become pregnant while taking the drug.
Women who take Accutane are advised to use at least two forms of contraception -- condoms and birth control pills, for example -- and take monthly pregnancy tests. They are also advised to have two consecutive negative pregnancy tests before starting the drug, and to register with a national survey that monitors women who use it.
Hoffmann-La Roche Inc., which makes Accutane, includes a written caution on its packaging about the risks to developing fetuses from the chemical. To drive home the point, the packaging also has the strong graphic.
However, the study, published in the September issue of the journal Teratology, shows that only 21 percent of women surveyed readily identified that symbol as a warning against using the drug while pregnant -- or of getting pregnant while taking it.
Of the 97 women of childbearing age surveyed, the researchers found that more than a quarter thought the pictogram meant the drug was a form of birth control, 24 percent thought it meant the package contained some form of medication, and 7 percent said they didn't know its significance. Moreover, almost four in 10 women said they could think of situations in which the drug could be shared, a practice expressly discouraged with Accutane.
Experts note that the survey didn't include women who use Accutane, who would presumably have undergone counseling by a doctor familiar with the product's strict usage requirements.
However, the authors write, the results serve as an "urgent call for mandating education for all patients receiving drugs with teratogenic properties, and careful pre-testing and modification of warning symbols before they are used on medications with teratogenic effects."
Carolyn Glynn, a Hoffmann-La Roche spokeswoman, says the company has conducted "extensive" testing of its warning label's effectiveness since the drug was introduced in 1982.
"According to our data, the symbol is very clear and well-recognized," Glynn says. She notes that the drug firm Celgene has used the same image on its packaging for its version of thalidomide, which can also cause severe birth defects.
Another report in the journal shows that between 1982 and March 2000, the Food and Drug Administration received reports of more than 2,000 pregnant women who were exposed to Accutane.
But health officials say the actual number is likely to be larger than that, because many women don't fully report their pregnancy histories and sexual activity.
Dr. Jonca Bull, an FDA official familiar with both studies, says that although the agency is "concerned" about the findings, the number of pregnant women exposed to Accutane is relatively small compared to the hundreds of thousands of doses prescribed over the 18-year reporting period.
And while the agency is in the process of beefing up the risk-management plan Hoffman-La Roche has in place for the drug, product labeling is only one component of that program.
Dr. Ivor Caro, a dermatologist at Harvard Medical School in Boston, calls the survey results "distressing," but adds that the fact that it didn't look at women taking the drug is reassuring.
In his own practice, Caro says he "makes women sign their life away" in written promises that they won't get pregnant during their months of Accutane therapy, and that if they do they're willing to have an abortion.
" 'Mandatory' is not the right word, but it should be the standard of care that they sign a consent form" with these stipulations, he says.
As for the number of women who do become pregnant during treatment, Caro says the rate has probably slowed in recent years.
But he adds, although dermatologists are almost certainly aware of the risks of Accutane, non-specialists may be less familiar with its hazards and thus less likely to counsel young female patients about the need to avoid conceiving.
What To Do
Accutane has been accused of sparking suicidal thoughts, and even of leading to suicide, in some people who take it. But recent research hasn't borne out such a link.
To learn more about Accutane, try Roche. The FDA also has information about the drug.
You can also try the Centers for Disease Control and Prevention.
