FDA
News Digest
July
5, 2005
__________________________________________________
IN THIS WEEK'S
ISSUE
-- Possible
Adult Suicide-Antidepressant Link Under FDA Review
-- FDA: 'Highly Unlikely' Green Tea Lowers Breast, Prostate Cancer Risk
-- FDA
Grants Another Tentative Approval for AIDS Relief Drug
-- Recalls/Safety Alerts
-- Public Meetings
-- Question of the Week
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Possible Adult
Suicide-Antidepressant Link Under FDA Review
FDA is
conducting a review of available data to determine if there is an increased risk
of suicidal behavior in adults taking antidepressants. The review will involve
data from hundreds of clinical trials and may take more than a year to complete.
Meanwhile, echoing warnings already present in the labeling of antidepressants,
FDA is advising close observation of adults being treated for depression for
signs of increased suicidal thinking or behavior.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01362.html
FDA: 'Highly
Unlikely' Green Tea Lowers Breast, Prostate Cancer Risk
Based on a review of available scientific data, FDA has determined that it is "highly unlikely" that green tea consumption lowers the risk of breast or prostate cancer. The agency also concluded that existing evidence does not support qualified health claims for green tea consumption and a reduced risk of any other type of cancer. http://www.fda.gov/bbs/topics/NEWS/2005/NEW01197.html
FDA Grants Another
Tentative Approval for AIDS Relief Drug
FDA has
granted tentative approval of generic stavudine tablets made by
Aurobindo Pharma for the treatment of HIV/AIDS. The agency's tentative approval
means that though existing patents or exclusivity agreements prevent U.S.
marketing of Aurobindo's product, the drug meets FDA's standards for
quality, safety, and effectiveness and it will
now be available for consideration for purchase and use outside the United
States under the President's Emergency Plan for AIDS Relief
(PEPFAR).Stavudine -- in a class of drugs that helps keep the
AIDS virus from reproducing-- is used in combination with other drugs. http://www.fda.gov/bbs/topics/NEWS/2005/NEW01199.html
To view an archive
of past FDA news releases, go to
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
Recall
Alerts:
FDA has classified
the risk levels of 11 different models of recalled implantable defibrillators
manufactured by Guidant Corp. Because serious consequences, including death,
can occur if these devices malfunction, FDA is releasing the information to
help patients and doctors take appropriate action.
http://origin.www.fda.gov/bbs/topics/NEWS/2005/NEW01198.html
Other
Recalls:
All products containing Cold Stone Creamery's Cake Batter ice cream
Reason for recall: possible Salmonella contamination (products may be associated with a Salmonella outbreak in several states)
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01200.html
Approximately
5,000 Vail Products enclosed or canopied bed systems; Models 500, 1000 and 2000
(revised recall notice)
Reason for recall: patients can become trapped, causing asphyxiation or death
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01196.html
Hemashield Vantage
Peripheral Vascular Grafts
Reason for recall: device could fray or tear during suturing
http://www.fda.gov/oc/po/firmrecalls/bostonsci06_05.html
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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PUBLIC
MEETINGS
July 13-14
-- Pulmonary-Allergy
Drugs Advisory Committee
Under discussion:
asthma drugs
Location:
Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12545dd07131405.html
July 13-15 --
Food Advisory
Committee
Under discussion:
food allergen thresholds
Location:
Greenbelt, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cfsan10564ddd0713141505.html
July 20 --
Public Workshop on
Leukocyte Reduction of Blood and Blood Components
Location:
Bethesda, Md.
http://www.fda.gov/cber/meetings/leuko072005.htm
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
Does a patient
need to have a doctor refer her to a mammography facility?
No. She can have a
mammography exam and receive the follow-up report without a doctor's referral
(this is called a "self referral). Before her exam, she should verify that the
facility accepts self-referred patients because some facilities do
not.
-- More
information: http://www.fda.gov/CDRH/MAMMOGRAPHY/
__________________________________________________
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