FDA News Digest for May 23, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

May 23, 2005

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IN THIS WEEK'S ISSUE

 

--  FDA Reports 'Significant Progress' in Curbing Fake Rx Drugs

--  FDA Warns Against Abuse of Cough, Cold Medicine Ingredient DXM

--  Members of New Drug Safety Oversight Board Announced

--  Latest FDA Consumer Magazine Available Online

--  Recalls/Safety Alerts

--  Recent Speeches

--  Public Meetings

--  Question of the Week

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FDA Reports 'Significant Progress' in Curbing Fake Rx Drugs

 

In an update to a 2004 agency report on combating counterfeit drugs, FDA has announced "significant progress" in the battle against fake prescription medicines. Agency actions include nearly doubling the number of counterfeit drug investigations in 2004 compared to 2003. These involved hundreds of thousands of fake dosage units. The past year also saw advances in implementing a standard prescription drug tracking system using radio frequency identification.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01179.html

-- Original 2004 report: http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html

-- 2005 update: http://www.fda.gov/oc/initiatives/counterfeit/update2005.html

 

FDA Warns Against Abuse of Cough, Cold Medicine Ingredient DXM

 

Following the deaths of five teenagers, which may be related to abuse of dextromethorphan (DXM), an ingredient found in many over-the-counter (OTC) cough and cold remedies, FDA is warning the public of the potential harm of DXM abuse. The agency stresses that DXM is safe when used as directed in properly formulated OTC drugs. But FDA reports a trend involving the sale of pure powdered DXM as a street drug. DXM abuse can cause brain damage, seizure, loss of consciousness, irregular heartbeat, and death.

-- Press release: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01360.html 

-- More information: http://www.family.samhsa.gov/get/otcdrugs.aspx

 

Members of New Drug Safety Oversight Board Announced 

 

As part of recent initiatives aimed at ensuring drug safety, FDA has announced the formation of a new board that will provide oversight and advice in managing drug safety issues. The Drug Safety Oversight Board, made up of scientists from FDA and other federal agencies, also will oversee the flow of emerging drug safety information to patients and health care professionals through a proposed Drug Watch Web site.

-- Press release:  http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01359.html

-- List of board members: www.fda.gov/cder/drug/DrugSafety/DSOBMembers.pdf

 

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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Latest FDA Consumer Magazine Available Online

 

 The May-June 2005 issue of FDA Consumer has articles on the following topics:

 

-- Hearing loss -- How to help overcome this age-related condition.

-- Human tissue transplants -- New FDA rules help prevent disease transmission. 

-- Whooping cough -- Children aren't the only ones who need to be protected from this infectious disease.

-- Healthier eating -- These tips can help you make smarter food choices.

-- Dry eye -- How to get relief from this disorder.

-- Laser pointers -- FDA is concerned about the misuse of these devices.

-- NSAIDs -- FDA is taking steps to guide the millions who rely on these pain-relieving drugs.

-- FDA reforms -- HHS Secretary Leavitt envisions a new kind of agency openness and oversight.

 

The issue is online at http://www.fda.gov/fdac/305_toc.html.

Subscribe to print version of FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html.

 

Note: The National Association of Government Communicators (NAGC) has awarded FDA Consumer first place in the national magazine category of the annual NAGC Blue Pencil contest. Also, three feature articles from the magazine won Awards of Excellence in the competition.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01181.html

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RECALLS/SAFETY ALERTS

 

Recalls:

 

Various brands of CaJohn's Fiery Foods Co.'s barbeque sauces

Reason for recall: undeclared anchovies, soybeans and wheat

http://www.fda.gov/oc/po/firmrecalls/cajohns05_05.html

 

Asian Taste Dried Sweet Potato-strips (7 oz. size)

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/walong05_05.html

 

Reissued alert: Ziyad brand Tahini and Ghandour Tahina Extra Sesame Butter

Reason for recall: possible Salmonella contamination

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01358.html

 

 

Safety Alerts:

 

The Master's Miracle is warning consumers not to apply the company's TMM brand Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer to the eyes because these products may be contaminated with bacteria that could cause serious injury, including blindness. The products are marketed as dietary supplements and are not intended for use in the eyes.

http://www.fda.gov/oc/po/firmrecalls/mastersmiracle05_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

 

May 11--Acting FDA Commissioner Lester M. Crawford, DVM, spoke before the 2nd National Forum on Obesity Policy, Regulation, and Litigation.

Subject: the Department of Health and Human Services' current and planned obesity-related activities

http://www.fda.gov/oc/speeches/2005/obesity0511.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

 

June 8 -- Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Under discussion: FDA's Critical Path Initiative and issues related to postmarket study design.

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12523d060805.html

 

June 10 -- Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants

Under discussion: the possibility of a comprehensive study report derived from an Air Force Health Study.

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/nctr12560d061005.html

 

June 13-14 -- Workshop on Biological Products for Treatment of Rare Plasma Protein Disorders

Under discussion: Scientific and regulatory challenges in development of these products.

Location: Bethesda, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-9011.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 control pesticides in foods?

 

The Environmental Protection Agency (http://www.epa.gov) regulates the sale and use of pesticides. But FDA regularly tests foods to determine if pesticides are present in unacceptable amounts.

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