| Subject: | FDA Announces New Labeling Requirements for Mifeprex (RU-486) |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 6 Jan 2005 - 10:00 am |
| The FDA has announced labeling changes to the drug Mifeprex (mifepristone) from Danco Laboratories. Mifeprex is also known as the RU-486 pill to terminate early pregnancy. Labeling changes are required for patient safety reasons, as the FDA and Danco have received reports of ruptured ectopic pregnancies, bleeding, serious bacterial infection, and death, including death from sepsis. Changes in labeling will be made to the existing black box on the product that includes the risks of the... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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