FDA News Digest
July 11, 2005
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IN THIS WEEK'S ISSUE
-- Reports of Eye Problems Prompt Label Change for Impotence Drugs
-- FDA Issues Nationwide Alert on Orchid Island Unpasteurized Orange Juice
-- First Generic Lamivudine/Zidovudine Tentatively Approved for AIDS Relief
-- FDA Observes 10 Years of Inspecting Mammography Facilities
-- Recalls/Safety Alerts
-- Public Meetings
-- Question of the Week
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Reports of Eye Problems Prompt Label Change for Impotence Drugs
Following a small number of post-marketing reports of sudden vision loss, FDA has approved updated labeling for the erectile dysfunction (impotence) drugs Viagra, Cialis and Levitra. The vision problems have been attributed to a condition where blood flow to the optic nerve is blocked. FDA urges patients taking these drugs who experience sudden vision loss or decreased vision in one or both eyes to stop taking the drug and contact a medical professional right away.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01201.html
FDA Issues Nationwide Alert on Orchid Island Unpasteurized Orange Juice
FDA has warned consumers not to drink unpasteurized orange juice distributed under a variety of brand names by Orchid Island Juice Company of Fort Pierce, Florida, The products may be contaminated with Salmonella typhimurium and have been associated with an outbreak of illness caused by this bacterium.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01203.html
First Generic Lamivudine/Zidovudine Tentatively Approved for AIDS Relief
FDA has tentatively approved the first generic version of the fixed-dose combination of lamivudine and zidovudine to treat HIV and AIDS. The product will now be available for use outside the United States under the President's Emergency Plan for AIDS Relief.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01202.html
FDA Observes 10 Years of Inspecting Mammography Facilities
FDA's Center for Devices & Radiological Health is celebrating the tenth anniversary of its first inspection of a mammography facility under the Mammography Quality Standards Act (MQSA). Congress enacted MQSA to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. In 1995, FDA began enforcing MQSA by initiating a facilities inspection program.
http://www.fda.gov/cdrh/mammography/tenthanniv.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
OBIM (Ready Pac affiliated producer) fresh-cut cantaloupe
Reason for recall: salmonella
http://www.fda.gov/oc/po/firmrecalls/readypac07_05.html
Kirin Soft Drink (Tea), 1.5-liter size
Reason for recall: undeclared milk
http://www.fda.gov/oc/po/firmrecalls/nishin07_05.html
Fortune Star White Fungus, 3-oz. size
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/ho07_05.html
Spreadables brand Lobster Bisque and Crab Creole cheese spreads
Reason for recall: undeclared egg, wheat and fish
http://www.fda.gov/oc/po/firmrecalls/roth07_05.html
Main Street Gourmet's Cinnamon Almond Dark Chocolate Biscotti
Reason for recall: undeclared milk
http://www.fda.gov/oc/po/firmrecalls/mainstreet06_05.html
Peekay International's raisins, 7-oz. size
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/peekay07_05.html
Golden Taste Baked Salmon Salad, various sizes
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/goldentaste07_05.html
Golden Taste Tuna Deluxe, Scallion Tuna Deluxe, and White Fish Salads; various sizes
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/goldentaste206_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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RECENT SPEECHES
June 8 -- FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Canada National Food Safety Summit
Subject: FDA's food-related priorities for 2005 and beyond.
http://www.fda.gov/oc/speeches/2005/canadafs0608.html
June 6 -- FDA Acting Commissioner Lester M. Crawford, D.V.M., before the World Pharma IT Congress.
Subject: Health information technology.
http://www.fda.gov/oc/speeches/2005/worldpharma0606.html
To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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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
July 21 -- Blood Products Advisory Committee
Under discussion: updates on several recent blood-related workshops
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516d072105.html
July 22 -- Research Review Subcommittee of the Blood Products Advisory Committee
Under discussion: a research program to facilitate development of biological products
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516d072205.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
What are 'hypoallergenic' cosmetics?
"Hypoallergenic" cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, may be led to believe that these products will be gentler than non-hypoallergenic cosmetics.
There are no federal standards or definitions that govern the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA.
The term "hypoallergenic" may have considerable market value in promoting cosmetic products to consumers on a retail basis, but dermatologists say it has very little meaning.
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