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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Feb 2008 09:00:28 -0600 (CST)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Feb 2008 10:20:34 -0600 (CST)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: February 20, 2008 |
The following new items were added to the CDRH web pages on February 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Medical Device Safety Article: Epidural Conduction Device Fractures and Complications of Retained Fragments |  |
| Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Nature and Basis Statements of Conflict(s) of Interest | |
| Risk Communication Advisory Committee; Notice of Meeting | |
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Feb 2008 14:43:55 -0600 (CST)
Subject: FDA Update for Health Care Professionals - February 20, 2008
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, announcements, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION
Actavis Recalls Certain Fentanyl Patches in the US as Precaution (Feb 17)
Actavis Inc., announced that 14 lots of Fentanyl transdermal system CII patches sold in the U.S are being voluntarily recalled from wholesalers and pharmacies as a precaution. The patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel.
Pricara™ Recalls 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII Pain Patches (Feb 12)
PriCara, said that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the U.S. are being voluntarily recalled as a precaution from wholesalers and pharmacies. The patches may have a cut along one side of the drug reservoir within the patch.
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions (Feb 11)
FDA announced 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.
Click here for a transcript of the February 11, 2008 FDA press conference on Adverse Events Associated with Baxter Healthcare Corporation’s Multiple-Dose Vials of Injectable Heparin.
· On February 18, 2008, FDA held a follow-up press conference on this topic. A replay of the briefing is available until March 14 by calling 866-459-3509.
FDA Notifies Public of Adverse Reactions Linked to Botox Use (Feb 8)
FDA notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
Click here for a transcript of the FDA press conference on FDA’s Early Communication on Botox, Botox Cosmetic and Myobloc
Chattem Issues URGENT Voluntary Nationwide Recall of Icy Hot® Heat Therapy™ Products (Feb 8)
Chattem, Inc. announced that it is initiating 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. These products are being recalled because of consumer reports of first, second and third degree burns as well as skin irritation resulting from consumer use or possible misuse of these products.
New Era Canning Company Expands Nationwide Recall (Feb 7)
FDA is alerting consumers, food service operators, and food retailers that New Era Canning Company, New Era, Mich., is broadening its nationwide recall of canned vegetable products for a third time because of the potential for its foods to be contaminated with Clostridium botulinum (C. botulinum).
PRODUCT APPROVALS:
FDA Clears for Market First Decellularized Heart Valve (Feb 7)
The U.S. Food and Drug Administration today cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed.
RECENT ANNOUNCEMENTS:
My Medicines - This Brochure Can be a Lifesaver (Feb 19)
My Medicines, the title of a brochure offered by FDA's Office of Women's Health, can play a vital role in the medical treatment you receive during an emergency. My Medicines features a chart that allows you to list information about your prescription medicines, including the names of the medicines, how much you take, when you take them, what condition they are treating, and the number of refills.
FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products (Feb 15)
FDA issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
UPCOMING MEETINGS:
FDA Risk Communication Advisory Committee
DATE AND TIME: February 28-29, 8 a.m.
LOCATION:
CONTACT: Lee L. Zwanziger, Office of the Commissioner,
Anti-Infective Drugs Advisory Committee
DATE AND TIME: February 27-28, 8 a.m.
LOCATION:
CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research, 301-827-7001. More Information
Oncologic Drugs Advisory Committee
DATE AND TIME: March 12-13, 8:00 a.m.
LOCATION: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave.,
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, 301-827-6793. More Information
Pediatric Advisory Committee
DATE AND TIME: March 25, 8:00 a.m.
LOCATION:
CONTACT: Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner, 301-827-3340. More Information
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below. If you do not wish to receive this information updates, you may unsubscribe at this link: FDA Consumer Health Information .
Sincerely,
Brenda L. Evelyn, SBB(ASCP) Janelle Derbis, PharmD
Office of Special Health Issues Office of Special Health Issues
(301) 827-4460 (312) 596-6516
(301) 443-4555 (fax) (312) 886-1682 (fax)
Brenda.evelyn@.fda.hhs.gov Janelle.derbis@fda.hhs.gov
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