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FDA Imposes New Restrictions On Roche's Accutane

by Medindia Content Team on  January 17, 2002 at 11:01 AM Drug News   - G J E 4
FDA Imposes New Restrictions On Roche's Accutane
Women taking Roche Inc's popular acne treatment Accutane (isotretinoin) will soon have to submit to new restrictions aimed at preventing unwanted pregnancies while on the drug. The US Food and Drug Administration (FDA) said that it has approved significant changes to the drugmaker's pregnancy prevention programme. The pregnancy prevention programme was adopted about 13 years ago, when Accutane was conclusively linked to birth defects and even faetal death.
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But in recent years, case reports have demonstrated that some women on the drug continued to get pregnant despite these well-document side effects. The FDA said that the new restrictions will include requiring women to take a pregnancy test every month to prove that they are not pregnant as well as to sign a consent form, showing that they are aware of the potential risks. The FDA added that pharmacists would now be restricted to dispensing a one-month supply to ensure that these restrictions are followed. The typical treatment period is about six months.

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In order to make the programme work, the FDA said that physicians wishing to prescribe the drug would receive yellow "Accutane Qualification Stickers'' that must be placed on the prescription as a means of verifying the negative pregnancy test and that the patient received the appropriate counseling. ''This sticker will indicate to the pharmacists that the patient is 'qualified,' the FDA said in a statement.
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