June 20, 2005
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IN THIS WEEK'S
ISSUE
-- FDA Grants Tentative Approval to Generic Drug for AIDS Relief
-- Antibiotic Treatment Tygacil Approved; First in a New Class
-- Recalls/Safety Alerts
-- Public Meetings
-- Question of the Week
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Antibiotic Treatment Tygacil Approved; First in a New Class
FDA has approved Tygacil for the treatment of adults with complicated intra-abdominal and complicated skin and skin structure infections, including infections due to methicillin-resistant Staphylococcus aureus (MRSA), a type of infection for which there are few treatment options. Tygacil, a glycylcycline antibiotic related to tetracyclines, retains activity against some bacteria that are resistant to tetracyclines.
-- Antibiotic resistance information: http://www.fda.gov/oc/opacom/hottopics/anti_resist.html
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news
releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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RECALLS/SAFETY ALERTS
Recalls :
Certain models of Guidant Corp.'s implantable defibrillators and cardiac resynchronization therapy defibrillators
Reason for recall: may develop short circuit, resulting in failure
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01185.html
Various drug products manufactured by Able Laboratories Inc. and repackaged by Quality Care Products LLC
Reason for recall: products may not have been produced according to quality assurance standards
http://www.fda.gov/oc/po/firmrecalls/qualitycare06_05.html
Accusure Insulin Syringes; 1 cc., 28 gauge, 1/2 inch
Reason for recall: mislabeling could cause incorrect dose
Golden Taste Tuna Deluxe; 3.5-oz. and 7.5-oz. sizes
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/goldentaste06_05.html
Kemps Bakery Classics French Silk Pie Ice Cream; 1/2-gal. size
Reason for recall: undeclared wheat
Initial recall notice: http://www.fda.gov/oc/po/firmrecalls/kemps06_05.html
Four states added to recall: http://www.fda.gov/oc/po/firmrecalls/kemps206_05.html
Chocolate cookies contained in Elegant Gourmet's "Camp Survival Kit"
Reason for recall: No ingredient listing is provided for cookies
http://www.fda.gov/oc/po/firmrecalls/elegant06_05.html
Lion Pavilion Ltd.'s Dried Cabbage Vegetable; 8.8-oz. size
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/lionpavilion06_05.html
Safety Alerts:
FDA is asking all sponsors of prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs) to revise their product labeling to include information about the increased risk of cardiovascular events and potentially life-threatening gastrointestinal bleeding. In the case of prescription NSAIDs, FDA has requested that labeling include a boxed warning.
http://www.fda.gov/cder/drug/infopage/COX2/default.htm
FDA has approved new labeling for Iressa (gefitinib) that limits the drug's indication to cancer patients who are benefiting or have benefited from treatment with the drug. The manufacturer will limit distribution of the drug under a risk management plan.
http://www.fda.gov/cder/drug/advisory/iressa.htm
For a list of recalls, market
withdrawals, and safety alerts involving FDA-regulated products from the past 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.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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To view an archive of
past testimony by FDA officials, go
to
PUBLIC
MEETINGS
June 22-23 -- Circulatory System Devices Panel of
the Medical Devices Advisory Committee
Under discussion: a premarket
approval application for a device intended to treat heart
failure
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12625dd06222305.html
June 23 -- Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory Committee
Under discussion: a premarket
approval application for a fetal heart monitoring device
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12524d062305.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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QUESTION OF THE WEEK
How can you find out about drug interactions, side effects, or adverse events associated with a certain medicine?
The drug labeling, or package insert, that accompanies drug products is the most complete single source of information on the drug. This labeling is available from your local pharmacist and also is reprinted in the Physician's Desk Reference (PDR), which can be found in many libraries. In addition, the package insert is available from the manufacturer and may often be found on the drug manufacturer's Web site. Labeling for drugs approved after 1998 may often be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Another option for finding more information on a drug's side effects is to request this through FDA's Freedom of Information (FOI) Office. You can find out more about this option and how to make an FOI request at http://www.fda.gov/foi/foia2.htm.
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