3/17/2006
Sepsis and Death Following Mifepristone (Mifeprex)
The United States Food and Drug Administration (FDA) has been informed
of two additional deaths following medical abortion with mifepristone
(Mifeprex). See eMedicine Recall and Alert July 20, 2005. The FDA
received verbal notification of the deaths in the United States from
the manufacturer, Danco Laboratories. An investigation of the
circumstances associated with these cases is ongoing and cause of death
has yet to be confirmed. Medical providers and their patients need to
be aware of the specific circumstances and directions for use of this
drug and all risks including sepsis when considering treatment.
Find more information at FDA MedWatch.
Medication recalls and alerts
September 14th, 2006 · 1 Comment
Tags: treatment
1 response so far ↓
1 Lonnie Nichol // Sep 16, 2006 at 7:10 am
3/2/2006
Recall for Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE
A Class I recall has been issued for Bard Composix Kugel Mesh X-
Large Patch Oval with ePTFE. The patch is used to repair ventral
(incisional) hernias caused by thinning or stretching of scar tissue
that may form after previous surgery. The “memory recoil ring” that
opens the Composix Kugel Mesh Patch after it has been inserted into
the intra-abdominal space can break. This can lead to bowel
perforations and/or chronic intestinal fistulae (abnormal
connections or passageways between the intestines and other organs).
Affected lot numbers include:
41XMXXXX M = 2002
41XNXXXX N = 2003
43XMXXXX M = 2002
43XNXXXX N = 2003
43XOXXXX O = 2004
43XPXXXX P = 2005
If the lot number does not contain the letters M, N, O, or P as the
4th character, the lot is not affected by this recall. A Class I
recall is issued when a drug or device may pose serious health risks
to some users.
Find more information at FDA MedWatch.
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