FDA News Digest for May 1, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

May 1, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- First Treatment Approved for Rare Respiratory Disease

    -- Generic Version of Cholesterol Drug Pravachol Approved

    -- FDA Signs Information-Sharing Agreement with Sweden

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

First Treatment Approved for Rare Respiratory Disease

FDA has approved Myozyme, the first treatment for Pompe disease, a rare disorder that can cause death from respiratory failure in newborns and very young children. Myozyme was approved as an "orphan" product, a special designation for treatments that affect fewer than 200,000 patients in the United States in a year.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01365.html

 

Generic Version of Cholesterol Drug Pravachol Approved

FDA has approved the first generic version of the cholesterol-lowering drug Pravachol (pravastatin sodium tablets). The drug is used to treat patients at an increased risk of heart attacks and stroke due to elevated cholesterol levels. FDA says the approval is part of the agency's efforts "to counter rising healthcare costs by approving safe and effective generic alternatives."

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01363.html

 

FDA Signs Information-Sharing Agreement with Sweden

FDA and Sweden's Medical Products Agency have signed a "confidentiality arrangement" that will allow the two agencies to share certain non-public information, including data on law enforcement and drug safety. The agreement will help the two agencies coordinate global regulatory responses.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01364.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

Drug Recall:

 

NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse; all flavors; 16-oz. bottles

    Reason for recall: possible bacterial contamination

http://www.fda.gov/oc/po/firmrecalls/pascal04_06.html

 

Food Recalls:

 

Oriental King Brand Dried Vegetable; 4-oz. bags

    Reason for recall: undeclared sulfites

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

 

Certain lots of Moveable Feast's Smoked Scottish and Smoked Norwegian Salmon; 4-oz. size

    Reason for recall: possible contamination with Listeria monocytogenes

http://www.fda.gov/oc/po/firmrecalls/moveable04_06.html

 

Safety Alerts:

 

FDA has notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported when the drug promethazine HCl was used in children less than two years old. The agency also urges parents and caregivers to get a doctor's advice about giving the drug to children age two and older.

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

 

FDA is recommending that healthcare providers take safety steps when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited problems that include under-infusion, battery failures, false alarms and failure to alarm.

http://www.fda.gov/cdrh/safety/042806-baxter.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

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

 

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 factors increase the risk of getting diabetes?

 

Although researchers don't fully understand why some people get diabetes and others don't, it is clear that certain factors increase your risk. You are at increased risk for having diabetes if:

• Your mother, father, sister, or brother has diabetes;
• You are African American, Hispanic American/Latino, American Indian, Native Alaskan, Asian American, or Pacific Islander;
• You have high blood pressure (at or above 130/80);
• You have a history of diabetes during pregnancy (gestational diabetes) or gave birth to a baby weighing more than nine pounds at birth;
• You are overweight or obese;
• You are inactive or have a sedentary lifestyle; or
• You are more than 45 years old.

If you have one or more of these risk factors, even if you are experiencing no symptoms, your doctor may want to test you for diabetes.

For more information about diabetes, see http://www.fda.gov/diabetes/.

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