FDA News
Digest
April 11, 2005
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IN THIS WEEK'S ISSUE
-- FDA Announces Label Revisions, Other Changes for NSAIDs
-- Sealant Can Prevent Cerebrospinal Fluid Leaks After Surgery
-- Recalls/Market Withdrawals
-- Public
Meetings
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FDA Announces Label Revisions, Other Changes for NSAIDs
FDA has asked makers of prescription non-steroidal anti-inflammatory drugs (NSAIDs) to add a boxed warning to product labeling that highlights the potential increased risk of cardiovascular events and gastrointestinal bleeding in users of the products. The agency also is asking non-prescription NSAID manufacturers to include information about the adverse effects, as well as a warning about potential skin reactions. As part of the NSAID actions, Pfizer Inc. has agreed to suspend sales of the prescription NSAID Bextra after scientific data showed the risks of using the drug outweigh the benefits.
http://www.fda.gov/bbs/topics/news/2005/NEW01171.html
Sealant Can Prevent Cerebrospinal Fluid Leaks After Surgery
FDA has approved the DuraSeal Dural Sealant System, which is applied over stitches after brain surgery to protect against leakage of cerebrospinal fluid. Leakage of the fluid can lead to serious complications such as headaches, infection, and meningitis. The sealant is intended for use in surgery of the dura mater, the tough, fibrous membrane that covers the brain and spinal cord, and lines the inner surface of the skull.
http://www.fda.gov/bbs/topics/news/2005/NEW01172.html
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RECALLS/MARKET
WITHDRAWALS
The following products
are being recalled for the reasons shown. Go to the linked page for more
information.
Mama's Smoked Nova Salmon, 8-oz. (possible Listeria monocytogenes contamination)
http://www.fda.gov/bbs/topics/news/2005/NEW01173.html
Couque D'asse Coffee Cookies (undeclared dairy ingredients)
http://www.fda.gov/oc/po/firmrecalls/sikpoom04_05.html
Store-made Pulpo Salad, sold in New York City area (possible Listeria monocytogenes contamination)
http://www.fda.gov/oc/po/firmrecalls/midatlantic04_05.html
PharMEDium Services Magnesium Sulfate in 5% Dextrose solution, 50 ml admixtures, all strengths (potential lack of sterility)
http://www.fda.gov/oc/po/firmrecalls/pharmedium04_05.html
Six lots of B1015-14 MicroScan Rapid Pos inoculum broth (possible inaccurate results)
http://www.fda.gov/oc/po/firmrecalls/behring04_05.html
For a list of recalls,
market withdrawals, and safety alerts involving FDA-regulated products from the
last 60 days, go to
http://www.fda.gov/opacom/7alerts.html
To access the RSS feed
of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
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PUBLIC
MEETINGS
April 11-13 --
General and Plastic
Surgery Devices Panel of the Medical Devices Advisory Committee; under
discussion: two pending
applications for approval of silicone gel-filled breast prostheses
(Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12519ddd0411121305.html
April 15 -- FDA Science Board; under discussion: FDA's pre- and post-marketing safety programs for drugs and biologics and good manufacturing practices for vaccines, blood, and cell, tissue and gene products (Rockville, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/fda12603d041505.htm
April 26-28 --
11th Annual FDA
Science Forum; includes a free public session April 26 on personalizing your
healthcare; remaining two days are devoted to scientific sessions on
nanotechnology, animal models, cancer diagnosis/treatment, risk management, and
other topics (Washington, D.C.)
http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.html
For a list of FDA
meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
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