FDA News
Digest
January 3,
2005
______________________________________________________________
THIS
WEEK'S NEWS
-- Court Orders Canada Care to Stop Importing Prescription Drugs
-- FDA Recommends Limited Use of Cox-2 Inhibitors
-- FDA OKs Genetic Lab Test That Helps Guide Medication Use
-- Web Site Offers Gateway to Reliable Tips on Weight Loss, Exercise
-- Recalls/Market
Withdrawals
-- Public
Meetings
______________________________________________________________
Court Orders
Canada Care to Stop Importing Prescription
Drugs
A
U.S. District Court has ordered Canada Care Drugs, Inc., to stop importing
prescription drugs. An FDA investigation revealed several products the company
sold that pose a public health risk.
-- Dec. 27, 2004 talk paper:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01337.html
-- Dec. 1, 2004 release:
http://www.fda.gov/bbs/topics/news/2004/NEW01142.html
FDA
Recommends Limited Use of Cox-2 Inhibitors
Following the recent release of clinical trial data showing that
Cox-2 inhibitor pain-relief drugs may be linked to an increased risk of adverse
cardiovascular effects, FDA has issued an advisory urging limited use of the
products and careful consideration by doctors of benefits versus risk. Issued as
an interim measure pending further review of data, the advisory covers various
non-steroidal anti-inflammatory drugs (NSAIDs), including prescription Cox-2
inhibitors such as Celebrex and Bextra, and over-the-counter and prescription
naproxen-based NSAIDS such as Aleve and Naprosyn.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01336.html
FDA OKs Genetic Lab Test That Helps Guide Medication Use
FDA
has approved the first laboratory test system to enable doctors to consider
unique genetic information from patients when selecting medicines and
determining appropriate doses. The AmpliChip Cytochrome P450 Genotyping Test
will help prevent harmful drug interactions, assure optimal drug use, and enable
patients to avoid less effective treatments.
http://www.fda.gov/bbs/topics/news/2004/new01149.html
______________________________________________________________
RECALLS/MARKET WITHDRAWALS
The
following products are being recalled for the reasons shown. Go to the linked
pages for more information.
Red
Diamond Brand Dried Chinese Vegetable (undeclared
sulfites)
http://www.fda.gov/oc/po/firmrecalls/starway12_04.html
Archway Holiday Cashew Nougat Cookies; 10-oz. package (may contain
glass fragments)
http://www.fda.gov/oc/po/firmrecalls/archway12_04.html
West Honest International Dried Lily Flower (undeclared
sulfites)
http://www.fda.gov/oc/po/firmrecalls/westhonest12_04.html
Asian Taste Dried Lily Flower (undeclared
sulfites)
http://www.fda.gov/oc/po/firmrecalls/walong12_04.html
Provato brand Manouri Traditional Greek Cheese (possible
Listeria monocytogenes contamination)
http://www.fda.gov/oc/po/firmrecalls/greekfoods12_04.html
For
a listing 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
______________________________________________________________
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
______________________________________________________________
Thanks for subscribing to FDA News Digest. Our next posting will
be
January 10.
To
leave this list at any time, send an e-mail to
In
the body of the message, write
SIGNOFF
FDA-NEWSDIGEST-L
