FDA News Digest for August 20, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

August 20, 2007

__________________________________________

 

IN THIS WEEK'S ISSUE

 

»  News

    --  Certain Diabetes Drugs to Carry Strengthened Warnings

    --  Updated Prescribing Information Approved for Coumadin

    --  Federal Court Issues Injunction Against Puerto Rico Dairy

»  Safety Alerts/Recalls

__________________________________________

 

NEWS

 

Certain Diabetes Drugs to Carry Strengthened Warnings

Manufacturers of certain drugs to treat type 2 diabetes have agreed to add a stronger warning on the risk of heart failure. The information will be included in the form of a "boxed" warning, FDA's strongest type of warning.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html

 

Updated Prescribing Information Approved for Coumadin

FDA has approved updated labeling for the blood-thinning drug Coumadin to explain that genetic makeup may influence how a patient responds to the drug. Manufacturers of warfarin, the generic version of Coumadin, also plan to add similar labeling information.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html

 

Federal Court Issues Injunction Against Puerto Rico Dairy

A federal district court in Puerto Rico has issued an injunction against J.M. Dairy Inc. after federal officials found illegal drug residues in cows. Under the terms of the order, the dairy must implement record-keeping systems to ensure that animal drug use conforms to FDA regulations.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01682.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.]

___________________________________________

 

SAFETY ALERTS/RECALLS

Dietary Supplement Recall:

 

›  One lot of Metaboslim Apple Cider Vinegar brand dietary supplement

    Reason for recall: contains undeclared drug ingredient

http://www.fda.gov/oc/po/firmrecalls/confidence08_07.html

 

Food Recall:

 

›  Four kinds of ready-to-eat seafood dips marketed by Ocean King Enterprises Inc. under the Regal King label

    Reason for recall: possible Listeria monocytogenes contamination  

http://www.fda.gov/oc/po/firmrecalls/oceanking08_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.]

_________________________________________________

 

Thanks for subscribing to FDA News Digest.

Our next issue will be sent August 27.

 

Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@xxxxxxxxxv.

 

To subscribe to or unsubscribe from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1.