FDA RECALLS + Cardiovascular Therapy Trials by Pfizer Inc stopped because of an INCREASE in patient deaths

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FDA News Digest

December 4, 2006

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IN THIS WEEK'S ISSUE

 

» News

-- Cardiovascular Therapy Trials Stopped for Safety Reasons

-- FDA Warns Horse Owners About Toxic Fumonisins in Feed

» Recalls/Safety Alerts

» Upcoming Public Meetings

» Question of the Week

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NEWS

 

Cardiovascular Therapy Trials Stopped for Safety Reasons

Pfizer Inc. has notified FDA that it is stopping late-stage clinical trials of the cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increase in patient deaths. An independent data safety monitoring board discovered the death increases through its periodic analysis of T/A trial data.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01514.html

 

 

FDA Warns Horse Owners About Toxic Fumonisins in Feed

A number of horses dies yearly from eating corn or corn byproducts containing fumonisins, a group of toxins produced by a mold within the corn kernel. These poisoning incidents often are linked to use of corn screenings -- small and broken corn kernels separated from whole corn during cleaning -- in horse feed. As a result, FDA is recommending against using corn screenings in horse feed.

http://www.fda.gov/cvm/Horsefumonisin.htm

 

 

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RECALLS/SAFETY ALERTS

 

 

Food Recall:

 

Krisp-Pak brand packaged fresh-cut fruit (with expiration dates on or before 11/30/06); various sizes

Reason for recall: possible Listeria monocytogenes contamination

 

http://www.fda.gov/oc/po/firmrecalls/krisppak211_06.html

 

Safety Alert:

 

FDA is alerting healthcare professionals who use methadone to treat patients for pain that the agency has received reports of death and life-threatening effects such as cardiac arrhythmias in patients taking methadone. FDA has created a Web page that gives suggested procedures to follow when prescribing the drug.

http://www.fda.gov/cder/drug/infopage/methadone/default.htm

 

 

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

 

 

Dec. 6 -- Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Under discussion: HDL/LDL cholesterol tests; FDA's Critical Path initiative

Location: Gaithersburg, Md.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=613

 

Dec. 6 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Under discussion: trials for new drugs to treat pediatric brain cancer

Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-18442.htm

 

Dec. 7-8 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

Under discussion: issues related to blood clotting in coronary drug-eluting stents

Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17519.htm

 

Dec. 18 -- Public hearing to solicit comments on electronic submission of premarket material and other regulatory information

Location: Rockville, Md.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01510.html

 

Jan. 9 -- Public Workshop on Marketed Unapproved Drugs

Under discussion: how businesses can obtain FDA approval to legally market currently unapproved drug products

Location: Rockville, Md.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01500.html

-- Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17959.htm

 

 

 

 

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

 

 

 

QUESTION OF THE WEEK

 

What is a biological product?

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances. Or they may be living entities such as cells and tissues.

 

Biologics are isolated from a variety of natural sources -- human, animal, or microorganism -- and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

 

For more on biologics, see http://www.fda.gov/cber/index.html.

 

 

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES has created a new website devoted to information and resources related to HIV/AIDS. Included is material on prevention, testing, treatment, and research programs. View the site at http://www.aids.gov/.

 

 

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To learn more about FDA's 100th birthday,

go to http://www.fda.gov/centennial/default.htm