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Accutane Label, iPledge Monitoring Program Changes Approved by FDA

Oct 18, 2007 | Parker Waichman LLP

Since an Accutane lawsuit against Roche is not uncommon phenomenon in the US and other countries that suffered hugely from this drug, the manufacturer was ordered to make changes into the popular acne remedy’s labeling. The label for Accutane will be changed in an effort to improve the effectiveness of the iPledge pregnancy risk management program.  The changes were announced by the Food & Drug Administration (FDA) earlier this month, and are based on recommendations made by an outside advisory panel over the summer.   The label changes will apply to both Accutane, the name brand of isotretinoin, and to its generic counterparts.  

Accutane and other forms of isotretinoin are used to treat severe acne, but they carry an extremely high risk of causing Accutane birth defects if a female patient is pregnant.  For that reason, pregnant women are barred from using Accutane.  The iPledge program was established in 2006 as a way to make sure that women taking accutane were not or did not become pregnant while using it.  It required, among other things, that female patients submit to regular pregnancy tests and that they sign a promise to use contraceptives while taking Accutane.

But earlier this summer, a report was released showing that the FDA’s iPledge program was not entirely successful in keeping the drug from expectant mothers. In its first year, 122 women in the iPledge program were either pregnant when they started taking Accutane, or became pregnant while doing so.  In some cases, the pregnancy test the women took prior to getting their Accutane prescription had a false-negative reading. In two cases, the women actually convinced their doctor to enter fake test results into the iPledge database.  But most of the pregnancies were the result of contraceptive failure.

Many dermatologists also complained that the iPledge program was too complicated and unwieldy.   This summer, an FDA advisory panel agreed with this assessment and recommended several changes to the iPledge program.  For example, it recommended doing away with rules that said a woman must have a pregnancy test and fill her Accutane prescription within seven days of seeing her doctor.  The panel recommended changing the rule to allow such a patient to get an Accutane prescription from her doctor within seven days of the test.  Another recommendation was to allow a patient to have a second pregnancy test and receive a new prescription if she misses the seven day window.  The FDA has decided to follow the advisory panel’s recommendation, and the new Accutane labeling will reflect these changes to the iPledge program.

Many of the changes were originally proposed by Roche AG, the maker of Accutane, and the other isotretinoin manufacturers.  They say the modifications will improve the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, doctors and pharmacies.

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