FDA News Digest
June 12,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- FDA Approves First Vaccine to Prevent Cervical
Cancer
-- Drug Approved to Treat Seasonal Affective
Disorder
-- New Measures Aimed at Protection from Counterfeit
Drugs
-- Efforts Against Unapproved Drug Products Strengthened
-- 2004 FDA/EPA Advice on Eating Seafood Still
Current
»
Recalls/Safety
Alerts
» Question of
the Week
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NEWS
FDA Approves First Vaccine to Prevent Cervical
Cancer
FDA has approved Gardasil, the first vaccine developed
to prevent cervical cancer, precancerous genital lesions, and genital warts
caused by four types of the human papillomavirus (HPV). About 6.2 million
Americans become infected yearly with HPV, the most common sexually transmitted
infection in the United States. Nearly 10,000 new cases of cervical cancer
appear annually, causing about 3,700 deaths. FDA calls the vaccine a
"significant advance."
Drug Approved to Treat Seasonal Affective
Disorder
FDA has approved Wellbutrin XL to prevent major
depressive episodes in patients with a history of seasonal affective
disorder (SAD), which usually coincides with the seasonal decrease in daylight
during fall and winter. The agency emphasizes that the drug should be used only
in those who meet strict diagnostic measures of seasonal
depression.
New Measures Aimed at Protection from
Counterfeit Drugs
As a defense against the growing problem of counterfeit
drugs, FDA is taking steps to ensure that drug distributors document the chain
of custody -- the so-called "pedigree" -- of products throughout the
distribution system. FDA also is urging distributors to work toward the goal of
widespread use of electronic methods of tracking product pedigrees, including radio frequency
identification.
Efforts
Against Unapproved Drug
Products Strengthened
Because several hundred unapproved active ingredients are
being used in prescription drugs, FDA is issuing guidelines for drug marketers to
bring products containing these
ingredients into legal compliance. The agency is focusing first on
unapproved products containing the antihistamine carbinoxamine. FDA is concerned
that children under 2 may take this ingredient, which is found in available
drops and syrups. Carbinoxamine has never been studied in very young children,
the agency says.
2004 FDA/EPA Advice on Eating Seafood Still
Current
An advisory issued two years ago by FDA and the
Environmental Protection Agency -- regarding safe seafood consumption for
women who are or might become pregnant, nursing mothers, and young children --
is still effective, FDA says. The 2004 advisory
emphasizes that
seafood can be an important
part of a healthy diet, but certain seafood types known to
have elevated mercury levels should be avoided or eaten in
moderation.
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.]
________________________________________________________
RECALLS/SAFETY
ALERTS
Device
Recall:
47 Raphael ventilators, with older
generation software
Reason for
recall: audible and visual alarms could fail to operate under specific
conditions
Food Recall:
Various Lakeside Foods products (coffee drinks, hot chocolate,
soups) sold in 10-oz. self-heating
containers
Reason for recall: spoilage organisms or bacterial contamination
due to seal leakage)
http://www.fda.gov/oc/po/firmrecalls/lakeside06_06.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.]
_____________________________________________
QUESTION OF THE WEEK
Does FDA have a phone number for
food safety information?
For general food safety questions,
call the FDA Food Safety Hotline at 1-800-723-3366. If the situation is
critical, phone FDA's emergency number, (301) 443-1240, which is staffed 24
hours a day.
If your questions involve meat or
poultry products, call the U.S. Department of Agriculture's hotline at
1-800-535-4555.
For more on food safety, see http://www.foodsafety.gov.
__________________________________________________
How's your knowledge of health topics such as
medical devices, prostate cancer, and "restless leg syndrome"? Find out
by taking our health quiz at http://www.fda.gov/fdac/quiz/onlinequiz29_js.html.
__________________________________________________
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To learn more about FDA's 100th birthday,
go to http://www.fda.gov/centennial/default.htm
