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Rules flexibility urged for users of Accutane


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 last week 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 seeing their doctor, rather than within seven days of the pregnancy test.

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 riskmanagement 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.

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