on behalf of Glen Drew [glen.drew@HHS.GOV]
Sent: Monday, February 11, 2008 1:50 PM
To: OHRP-L@LIST.NIH.GOV
Subject: OHRP Spanish Pamphlet Now Available
OHRP is pleased to announce that its pamphlet "Becoming a Research
Volunteer: It's Your Decision" is now available in Spanish, "Ser
Voluntario en Estudios Clínicos: Es Su Decisión."
You may order up to 50 (fifty) free copies by calling OHRP's toll-free
number, (866) 447-4777. You may also download at no charge an electronic
copy at http://www.hhs.gov/ohrp/espanol/OHRP3PanelSpanish.pdf
for your
own reprinting and distribution.
OHRP would like to hear about your experiences with the Spanish pamphlet.
Please tell us about them at ohrp@hhs.gov.
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: Mon, 11 Feb 2008 06:35:16 -0600 (CST)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: February 11, 2008 |
The following new items were added to the CDRH web pages on February 8, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System |  |  |
| FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008 | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 11 Feb 2008 13:04:40 -0600 (CST)
Subject: FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Fri, 1 Feb 2008 11:49:00 -0600
The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 11 Feb 2008 13:16:57 -0600 (CST)
Subject: FDA Press Releases Update
Correction: This press release was originally issued on February 1, 2008, and was inadvertently resent today. We apologize for any confusion.
FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Fri, 1 Feb 2008 11:49:00 -0600
The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 11 Feb 2008 14:05:29 -0600 (CST)
Subject: Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
Mon, 11 Feb 2008 11:10:00 -0600
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 11 Feb 2008 11:00:22 -0600 (CST)
Subject: FDA MedWatch- Chattem Icy Hot Heat Therapy Products- Nationwide Recall Due To Reports of First, Second And Third Degree Burns
  |
Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:
Icy Hot Heat Therapy Air Activated Heat - Back
Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg single consumer use "samples" on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream
Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer.
Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chattem
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 11 Feb 2008 14:45:46 -0600 (CST)
Subject: FDA MedWatch - Heparin Sodium Injection - Serious Adverse Events Reported In Patients Receiving Bolus Doses Of Medication
| |
FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.
The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Q & A Document, and News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2
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