FDA News
Digest
December 13,
2004
____________________________________________________________
IN THIS WEEK'S
ISSUE
-- Arthritis Drug Bextra to Carry Enhanced
Warnings About Risks
-- N.J. Man Arrested for Illegally
Importing Unapproved Flu Vaccine
-- Recalls/Market
Withdrawals
-- Public Meetings
____________________________________________________________
Arthritis Drug Bextra
to Carry Enhanced Warnings About Risks
FDA has announced new
warnings that will be included in labeling for the drug Bextra, which is used to
treat osteoarthritis, rheumatoid arthritis, and menstrual pain. The labeling
will emphasize the risk of life-threatening skin reactions and will warn against
using the drug in patients undergoing coronary artery bypass graft
surgery.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01331.html
N.J. Man Arrested for
Illegally Importing Unapproved Flu Vaccine
FDA and Customs agents
have arrested New Jersey resident Mahmoud Abuarquob after he allegedly attempted
to bring 810 doses of unapproved flu vaccine into the United States for sale to
a hospital at inflated prices. If convicted of the charges, Abuarquob faces up
to five years in prison and up to $10,000 in fines.
http://www.ice.gov/graphics/news/newsreleases/articles/fluvaccine120604.htm
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RECALLS/MARKET
WITHDRAWALS
The following products
are being recalled for the reasons shown. Go to the linked pages for more
information.
Carbolith
150-milligram capsules (Product may not provide adequate dose. Not approved in the
United States, this drug is being recalled in Canada, where it is used to treat
manic depression. FDA is investigating several Web sites offering the drug for
sale to U.S. consumers.)
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01330.html
Certain models of
Bio-Med Devices Inc.'s Patient Breathing Circuits (potential blockage
problem)
http://www.fda.gov/oc/po/firmrecalls/biomed12_04.html
Roche Diagnostics'
Cardiac Reader system (malfunction that could cause false
results)
http://www.fda.gov/oc/po/firmrecalls/roche12_04.html
Desly International
Corp.'s Chocolate Covered Marshmallows (Strawberry and Vanilla Flavor) On the
Stick (undeclared eggs)
http://www.fda.gov/oc/po/firmrecalls/desly12_04.html
Mana International
Foods' Chocolate Rugelach; 16-oz. size (undeclared nuts)
http://www.fda.gov/oc/po/firmrecalls/mana12_04.html
Palm Fan Dehydrated
Vegetable (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/starmark12_04.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
______________________________________________________________
PUBLIC
MEETINGS
Jan. 12-13 --
Industry Exchange
Workshop on FDA Clinical Trial Requirements (San
Francisco)
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26092.htm
Jan. 13-14 --
Joint
Meeting of the Nonprescription Drugs and the Endocrinologic and Metabolic Drugs
Advisory Committees; under discussion: proposal for over-the-counter sales of
the cholesterol-lowering drug Mevacor (Bethesda, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12536dd01131405.htm
For a list of upcoming
FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
______________________________________________________________
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