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Pregnancy Reported Despite Drug Warning
Tuesday, July 31st, 2007
From New York Times
More than 120 women became pregnant in the past year while taking an acne medicine that causes birth defects — despite being enrolled in a program designed to prevent those pregnancies from happening.
Long-awaited data from that national registry was released Monday, two days before the Food and Drug Administration was to bring together its scientific advisers to evaluate safety restrictions on Accutane and its generic competitors.
The new figures show the 122 pregnancies reported in the first year of the so-called iPledge program are about the same as the number reported annually before the FDA tightened restrictions on the drug, known chemically as isotretinoin.
Whether the tougher program is working becomes a question for Wednesday’s advisory committee debate.
It’s a difficult comparison because until the national registry began, officials weren’t sure if they were learning about all the pregnancies affected by this very risky drug, said FDA deputy drug director Dr. Sandra Kweder.
“Our goal of course is zero,” Kweder told The Associated Press on Monday.
But with pregnancies still occurring, “a big question is why is that,” she added. “These are women who for the most part have pregnancy tests, who are counseled about birth control, who say they understand the risks.”
If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. That’s a risk for 30 days after stopping the drug, too.
Isotretinoin is supposed to be for severe acne only, but it is widely acknowledged to be prescribed for more minor cases. The iPledge computerized registry, which became mandatory last year, marked 20 years of escalating FDA efforts to limit fetal exposures.
All patients — men and women — who want the drug must enroll, plus doctors who prescribe it and pharmacies that sell it. Women must meet additional requirements, including using birth control and passing pregnancy tests before each monthly refill.
Monday, the FDA posted on its Web site a report from isotretinoin manufacturers on iPledge’s first year. Among the findings:
–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.
–Of the 122 pregnancies, 78 were taking the drug when they became pregnant. Another 10 were already pregnant when they started isotretinoin, including two who had a prescriber falsify pregnancy test results. The report didn’t give a reason. Another eight became pregnant in the month after stopping the drug. The program couldn’t provide details on the remaining pregnancies.
–Most of the pregnancies appear due to forgetting to stick with their birth control plan. Some 72 percent of the women had reported they were using birth control pills and a male condom, and 18 percent said they had been relying on abstinence.
–Two prescribers were kicked out of the registry for not following rules.
Dermatologists have been critical of the program, saying it unnecessarily locked out some patients. On Wednesday, manufacturers were expected to ask that FDA tweak the rules to make it easier for all but at-risk women to comply.
The March of Dimes had pushed for the tougher program and was assessing whether changes are needed.
From New York Times
More than 120 women became pregnant in the past year while taking an acne medicine that causes birth defects — despite being enrolled in a program designed to prevent those pregnancies from happening.
Long-awaited data from that national registry was released Monday, two days before the Food and Drug Administration was to bring together its scientific advisers to evaluate safety restrictions on Accutane and its generic competitors.
The new figures show the 122 pregnancies reported in the first year of the so-called iPledge program are about the same as the number reported annually before the FDA tightened restrictions on the drug, known chemically as isotretinoin.
Whether the tougher program is working becomes a question for Wednesday’s advisory committee debate.
It’s a difficult comparison because until the national registry began, officials weren’t sure if they were learning about all the pregnancies affected by this very risky drug, said FDA deputy drug director Dr. Sandra Kweder.
“Our goal of course is zero,” Kweder told The Associated Press on Monday.
But with pregnancies still occurring, “a big question is why is that,” she added. “These are women who for the most part have pregnancy tests, who are counseled about birth control, who say they understand the risks.”
If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. That’s a risk for 30 days after stopping the drug, too.
Isotretinoin is supposed to be for severe acne only, but it is widely acknowledged to be prescribed for more minor cases. The iPledge computerized registry, which became mandatory last year, marked 20 years of escalating FDA efforts to limit fetal exposures.
All patients — men and women — who want the drug must enroll, plus doctors who prescribe it and pharmacies that sell it. Women must meet additional requirements, including using birth control and passing pregnancy tests before each monthly refill.
Monday, the FDA posted on its Web site a report from isotretinoin manufacturers on iPledge’s first year. Among the findings:
–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.
–Of the 122 pregnancies, 78 were taking the drug when they became pregnant. Another 10 were already pregnant when they started isotretinoin, including two who had a prescriber falsify pregnancy test results. The report didn’t give a reason. Another eight became pregnant in the month after stopping the drug. The program couldn’t provide details on the remaining pregnancies.
–Most of the pregnancies appear due to forgetting to stick with their birth control plan. Some 72 percent of the women had reported they were using birth control pills and a male condom, and 18 percent said they had been relying on abstinence.
–Two prescribers were kicked out of the registry for not following rules.
Dermatologists have been critical of the program, saying it unnecessarily locked out some patients. On Wednesday, manufacturers were expected to ask that FDA tweak the rules to make it easier for all but at-risk women to comply.
The March of Dimes had pushed for the tougher program and was assessing whether changes are needed.
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