U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:42:05 -0500 (CDT)
Subject: Drug Information Update- Transition from CFC to HFA Propelled Albuterol Inhalers

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

FDA is alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers. As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008.  Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. 

There are three HFA propelled albuterol inhalers that have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. Also FDA-approved is Xopenex HFA Inhalation Aerosol, an HFA propelled inhaler containing levalbuterol (the active form of albuterol).

HFA propelled albuterol inhalers may taste and feel different than the CFC propelled albuterol inhalers.  Notably, the force of the spray of an HFA propelled inhaler may feel softer than that of a CFC propelled inhaler.  It is important to remember that it is the deep breath that you take with each puff that gets the medication into your lungs, not the force of the spray. It is important to prime and clean the HFA propelled inhalers to prevent blockage in the inhaler device that will prevent the medicine from reaching the lungs.  Each HFA propelled inhaler has different priming, cleaning, and drying instructions.  Therefore, it is important to read and understand the instructions that come with each of the HFA propelled albuterol inhalers before using.

The labeling and instructions for the inhalers may be accessed at: http://dailymed.nlm.nih.gov/dailymed/about.cfm

The national transition from CFC propelled to HFA propelled albuterol inhalers is due to an international environmental treaty called the Montreal Protocol on Substances that Deplete the Ozone Layer.  Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS) including CFCs.  Several CFC propelled inhalers containing other medicines have already been phased out.  Over the next several years, other CFC propelled inhalers will be phased out.

If after following the instructions that come with each of the HFA propelled albuterol inhalers you feel the product is not effective or causing you to experience side effects we urge you to report to FDA's MedWatch program. MedWatch is a voluntary system of reporting to FDA any adverse effects and/or product problems. You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/medwatch/index.html),   click on "How to Report", then "Reporting by Health Professionals" or "Reporting by Consumers".

You can find more information at http://www.fda.gov/cder/mdi/albuterol.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 14:11:38 -0500 (CDT)
Subject: Drug Information Update- FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

• The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
• Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
• The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 09:39:55 -0500 (CDT)
Subject: Drug Information Heparin Update

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS).   Affected heparin products have been found in medical care facilities in one state since the recall announcement.  Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.  There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration.  Please see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm. 

We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.  

 

In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin.  To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html.  Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions.  

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 15:39:00 -0500 (CDT)
Subject: The May 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Highlighted articles include:

 

 

Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated

MedSun reporters and other healthcare facilities can still submit heparin reports to MedSun or MedWatch, and they will be directed to the attention of FDA’s Center for Drug Evaluation and Research (CDER)…

 

FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries

Draft guidelines have been issued by FDA to aid the development, testing and manufacture of coronary drug-eluting stents, and devices used to treat blocked heart arteries…

 

Preventing Accidents and Injuries in the MRI Suite

This article provides risk reduction strategies and Joint Commission recommendations to reduce MRI accidents, injuries, and deaths…

 

Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis

Healthcare facilities can use the published results of the failure mode and effects analysis to understand telemetry monitoring alarm response processes and as an aid to develop facility-specific risk reduction strategies…

 

Preventing the Retention of Foreign Objects during Interventional Radiology Procedures

The article provides recommendations and safe practices to help prevent the retention of foreign objects during interventional radiology (IR) procedures.  This includes the use of sponge, sharp and instrument counts in IR to prevent the risk of serious patient harm related to the retention of foreign objects in this setting… 

 

Low Frequency Magnetic Emissions and Resulting Induced Voltages in a Pacemaker by iPod Portable Music Players

Based on the observations of an in-vitro study, researchers concluded that no interference effects occurred in pacemakers exposed to the tested iPod devices…

 

FDA's Office of In Vitro Diagnostics Has Approved the Following New Devices for Marketing:
Dako TOP2A FISH pharmDx™ Kit is a laboratory test used to help a doctor assess the likely clinical course for certain patients with breast cancer. The test uses fluorescent DNA probes to measure the number of copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in breast cancer cells...

 

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here. 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420