FDA notifications. UCB Pharma and FDA issue advisory letter.
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The FDA now is making it easier to access consolidated records of advisory committee meetings.
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Netherlands Pharmacovigilance Foundation Lareb expulsion of the vaginal contraceptive ring NuvaRing was reported 8 times between February 2003 and April 2004. Moreover, in two of these reports pregnancy was reported. In that same period, Lareb received 10 more reports of pregnancy during the use of the ring, in which expulsion was not mentioned explicitly. Additional information on these cases was collected by questionnaire. Expulsion of the ring is described in the product information. The ring should then be placed back within 3 h. However, the Lareb reports show that expulsion of the ring is not always noticed by the user. In those cases the contraceptive efficacy of this method is questionable. The physician should be alert to pre-existing risk factors that increase the chance of expulsion of the ring, and should provide extra detailed advice about the right way of placing the ring, the risk of expulsion and the importance of replacing it in time.
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