FDA News -- FDA News Digest for March 31, 2008

FDA News Digest

March 31, 2008

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IN THIS WEEK'S ISSUE

» News

-- Recommendations Made on Devices That Treat Blocked Heart Arteries

-- 25 Drugs, Biologics Identified for Safety Plan Requirements

-- FDA Seeks Civil Penalties from California Maker of Hearing Aids

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

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NEWS

Recommendations Made on Devices That Treat Blocked Heart Arteries

FDA has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, which are devices used to treat blocked heart arteries. FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines outline the agency's recommendations for providing data to better address the clot issue and other potential safety concerns.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01810.html

25 Drugs, Biologics Identified for Safety Plan Requirements

FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS). FDA can require manufacturers to submit a REMS when a drug first comes on the market or later if FDA becomes aware of new safety data about the drug. Manufacturers of the 25 drugs and biologic products identified in today's notice must submit to the agency a proposed REMS by Sept. 21, 2008.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01811.html

FDA Seeks Civil Penalties from California Maker of Hearing Aids

FDA is seeking a $2.2 million penalty against California hearing aid manufacturer Advanced Bionics, LLC, for violations of federal law, including manufacturing standards violations and the failure to notify the agency of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks. The hearing aids pose a risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01813.html

To view an archive of recent 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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SAFETY ALERTS/RECALLS

Safety Alerts:

› FDA is advising consumers not to buy or use "Blue Steel" or "Hero" products, marketed as dietary supplements throughout the United States, because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect blood pressure level. They are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They are labeled as dietary supplements but do not qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in the ED drug Viagra.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01809.html

› FDA also is advising consumers not to buy or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html

Food Recalls:

› Honduran Cantaloupes grown by Agropecuaria Montelibano

Reason for recall: Salmonella contamination

http://www.fda.gov/oc/opacom/hottopics/cantaloupe.html

› Certain batches of Stonyfield Organic Fat Free Blueberry Yogurt, 6-oz. cups

Reason for recall: reported plastic or glass fragments in product

http://www.fda.gov/oc/po/firmrecalls/stonyfield03_08.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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UPCOMING PUBLIC MEETINGS

April 1-2 -- Anti-Infective Drugs Advisory Committee

Under discussion: product development and clinical trial design for community-acquired pneumonia

Location: Beltsville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-814.htm

April 4 -- Quality System Regulation Educational Forum on Design Controls, a public workshop for regulated industry, especially small businesses

Location: Dallas, Texas

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20077.htm

April 7-8 -- QT and Arrhythmia Issues in Drug Development

Under discussion: development of pharmaceutical agents, as well as challenges and solutions

Location: Bethesda, Md.

http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16004&eventType=Meeting

April 10-11 -- Cellular, Tissue and Gene Therapies Advisory Committee

Under discussion: safety testing for cellular therapy products derived from human embryonic stem cells

Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24629.htm

For a complete list of meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION

Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:

› Taking a Close Look at Ultrasound

http://www.fda.gov/consumer/updates/ultrasound032408.html

› Avoid Fetal “Keepsake” Images, Heartbeat Monitors

http://www.fda.gov/consumer/updates/keepsakevideo032408.html

To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html

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