FDA News Digest for February 12, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

February 12, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Rx Weight-Loss Drug Orlistat Approved for OTC Sales

    -- Two Approved Uses to be Removed from Antibiotic Ketek

    -- Device Cleared to Help Save Limbs of Critically Injured

    -- Two Firms to Stop Making Devices Pending Compliance

    -- Latest 'Patient Safety News' Video Available Online

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Rx Weight-Loss Drug Orlistat Approved for OTC Sales

FDA has approved orlistat as an over-the-counter (OTC) weight-loss aid for overweight adults. FDA first approved the drug in 1999 as a prescription treatment for obesity. Orlistat still will be dispensed by prescription for obesity at a higher dose than the OTC version, which will be sold under the name Alli. Orlistat helps produce weight loss by decreasing the intestinal absorption of fat.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01557.html

 

Two Approved Uses to be Removed from Antibiotic Ketek

After considering the risks and benefits of the three approved uses of the antibiotic Ketek (telithromycin), FDA has determined that two of those uses no longer support approval of the drug for those purposes. The two uses that will be dropped from the drug's labeling are acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. However, Ketek will stay on the market for treatment of mild-to-moderate community-acquired pneumonia.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html

-- Ketek information page: http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm

 

Device Cleared to Help Save Limbs of Critically Injured

FDA has cleared the Temporary Limb Salvage Shunt, a medical device that can help save the arms and legs of critically injured soldiers and other trauma victims. The device works by connecting the ends of a severed blood vessel, providing a bridge around the damaged area and restoring blood flow to the injured limb.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01559.html

 

Two Firms to Stop Making Devices Pending Compliance

Two medical device companies have agreed to stop making certain products until problems with legal compliance are resolved. California-based Cardinal Health 303 Inc. and three of its top executives have signed a consent decree in U.S. district court instructing them to correct manufacturing deficiencies before making and distributing any more of the company's Signature Edition infusion pumps. Likewise, Custom Ultrasonics Inc. has agreed to stop marketing its System 83 Plus Washer/Disinfectors and its System Plus 83 Mini-flex Washer/Disinfectors until manufacturing problems are resolved.

-- Cardinal Health 303: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01558.html

-- Custom Ultrasonics: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01556.html

 

Latest 'Patient Safety News' Video Available Online

FDA has posted the latest edition of "Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

http://www.fda.gov/psn

 

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

Device Recall:

 

HoMedics heating pads (produced in 2001 and sold in drug, discount and department stores)

    Reason for recall: poor connection could cause overheating

http://www.fda.gov/oc/po/firmrecalls/homedics02_07.html

 

Food Recalls:

 

Little Debbie Nutty Bars (recall confined to Georgia, North Carolina, Maryland and Virginia)

    Reason for recall: an ingredient may contain small metal particles

http://www.fda.gov/oc/po/firmrecalls/mckee02_07.html

 

Fortune Star brand Dried Lily Bulb; 10 oz. size

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/ho02_07.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

 

Feb. 16 -- Prescription Drug User Fee Act Public Meeting

    Under discussion: reauthorization of the user fee program

    Location: Washington, D.C.

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-122.htm

 

Feb. 22 -- Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for approval of a hip resurfacing system

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-946.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 FDA have a phone number for food safety information?

 

Yes. 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.

 

However, 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.

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HOW'S YOUR KNOWLEDGE of health topics such as vaccines

and food additives? Find out by taking our FDA Consumer quiz

at http://www.fda.gov/fdac/quiz/onlinequiz33_js.html.

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