FDA News Digest for May 8, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

May 8, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Program Launched to Assess Advisory Committee System 

    -- Executives Convicted in Illegal Sterilization Device Scheme

    -- FDA Approves New Treatment for Rare Bone Marrow Disorder

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Program Launched to Assess Advisory Committee System 

FDA has begun an internal assessment of its advisory committee meeting system with a goal of establishing best practices. Advisory committees are designed to provide independent, expert advice to FDA on complex scientific issues. Practices to be evaluated include nominating committee members, choosing consultants with specific expertise, and screening for conflict of interest.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01368.html

 

Executives Convicted in Illegal Sterilization Device Scheme

Following a nine-week trial, two executives of an Illinois-based company have been convicted in a federal district court of fraudulently selling unapproved surgical sterilizing devices to hospitals. The scheme led to eye damage in 18 patients, causing them to lose sight in one eye. Sentencing, which could include imprisonment, fines and restitution, will occur at a later date.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01367.html

 

FDA Approves New Treatment for Rare Bone Marrow Disorder

FDA has approved Dacogen, an injectable drug treatment for myelodysplastic syndromes (MDS), a group of rare disorders in which the bone marrow does not produce enough mature blood cells. About 7,000 to 12,000 new cases of MDS are diagnosed yearly in this country, most frequently in patients over age 60.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01366.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.]

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RECALLS/SAFETY ALERTS

Device Recall:

 

Respironics Inc.'s PLV Continuum Ventilator; all models

    Reason for recall: device may stop suddenly, possibly resulting in serious injury or death

http://www.fda.gov/oc/po/firmrecalls/respironics05_06.html

 

Drug Recall:

 

Goldline brand Extra Strength Genapap 500 mg (acetaminophen) caplets and tablets, and Goldline Extra Strength Genebs 500 mg (acetaminophen) caplets and tablets

    Reason for recall: labeling error

http://www.fda.gov/oc/po/firmrecalls/ivax05_06.html

 

Food Recall:

 

Oriental King Brand Dried Vegetable; 4-oz. size

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/monchong04_06.html

 

Safety Alert:

 

FDA is notifying healthcare professionals and consumers of reports of acute phosphate nephropathy, a type of acute kidney failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet  Phospho-soda or Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol).

http://www.fda.gov/cder/drug/infopage/osp_solution/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

May 17 -- Peripheral and Central Nervous System Drugs Advisory Committee

    Under discussion: a proposed treatment for dementia associated with Parkinson's disease

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d051706.html

 

May 17-18 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: FDA and industry perspectives on proper conduct of clinical trials regulated by FDA

    Location: Baltimore

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-3229.htm

 

May 18 -- Vaccines and Related Biological Products Advisory Committee

    Under discussion: safety and effectiveness of a human papillomavirus vaccine

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-6509.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 

 

What risks are involved with taking counterfeit medications?

Patients taking counterfeit medicines may experience unexpected side effects, allergic reactions, or a worsening of their medical condition. Some counterfeits do not contain any active ingredients, and instead contain inert substances, which do not provide the patient any treatment benefit. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or hazardous ingredients.

The extent of the problem of counterfeit drugs is unknown. Counterfeiting is difficult to detect, investigate and quantify. What is known is that they occur worldwide and are more prevalent in developing countries. It is estimated that upwards of 10 percent of drugs worldwide are counterfeit, and in some countries more than half of the drug supply is made up of counterfeit drugs. Counterfeiting occurs less frequently in the U.S. than in other countries due to strict guidelines, regulations and enforcement.

For more on counterfeit drugs, see http://www.fda.gov/counterfeit/.

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