Wednesday, August 13, 2008

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

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 12 Aug 2008 07:02:32 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution
Fri, 08 Aug 2008 15:08:00 -0500

See Web site for additional information on this Current Drug Shortage


Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 12 Aug 2008 09:09:37 -0500 (CDT)
Subject: FDA Consumer Education about Medicine

You are subscribed to FDA Consumer Education about Medicine for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

"Tips for Talking with Your Pharmacist - to learn how to use medicines safely." Tips to help you in the pharmacy -- what to tell and ask your pharmacist, and what to do after you get the medicine from your pharmacist. Available in html or a printable, high resolution PDF version.

It's linked off the "Consumer Education-Ensuring Safe Use of Medicine" page at http://www.fda.gov/cder/consumerinfo/ensuring_safe_use_text.htm, or you can go directly to it at: http://www.fda.gov/cder/consumerinfo/stop_learn_go_pharmacist.htm.


Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 12 Aug 2008 13:03:15 -0500 (CDT)
Subject: Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11)

Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11)
Tue, 12 Aug 2008 12:39:00 -0500

Home Made Brand Foods is voluntarily recalling approximately 4890 pounds of Ready-to-Eat Tuna Salad with an expiration date of 8/19/08. This product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.


Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 12 Aug 2008 14:03:08 -0500 (CDT)
Subject: Potential Problems at Two Baltimore Pharmacies

Potential Problems at Two Baltimore Pharmacies
Tue, 12 Aug 2008 13:02:00 -0500

FDA is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit.


Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 12 Aug 2008 16:47:33 -0500 (CDT)
Subject: CDER New 7/12/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

August 12, 2008

  • FDA issues an Information for Healthcare Professionals sheet for Naltrexone. Drug Information.
  • New and Generic Drug Approvals
    • Ak-Fluor (fluorescein sodium) Injection, Akorn, Inc., Approval
    • Cefazolin Injection, Aurobindo Pharma, Ltd., Approval
    • Zovirax (acyclovir) Capsules, GlaxoSmithKline, Labeling Revision
    • Zovirax (acyclovir) Oral Suspension, GlaxoSmithKline, Labeling Revision
    • Zovirax (acyclovir) Tablets, GlaxoSmithKline, Labeling Revision


Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 12 Aug 2008 14:19:04 -0500 (CDT)
Subject: FDA MedWatch -Vivitrol (naltrexone)- Serious Injection Site Reactions May Occur

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

Read the entire MedWatch Safety Summary, including a link to the FDA Drug Information Page regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone


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