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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 05:45:14 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: March 28, 2008 |
The following new items were added to the CDRH web pages on March 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |  |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 06:02:02 -0500 (CDT)
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: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 11:04:18 -0500 (CDT)
Subject: Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)
Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)
Fri, 28 Mar 2008 10:25:00 -0500
The recalled product was distributed nationwide to wholesalers and grocery stores. Whole cantaloupe fruits subject to this recall are packed three melons in a sleeve under the brand "Chestnut Hill Farms" and one melon per sleeve under the "Perfect Melon" brand. Individual melons are not labeled, but sleeves contain tags that say either "Perfect Melon" (one count) or "Chestnut Hill Farms" (3 count). Whole cantaloupe fruits subject to this recall were sold in boxes marked with the following text: "Cantaloupe, "Chestnut Hill Farms" (3 count) or "Perfect Melon" (one count), Produce of Honduras, Grown, Packed and Shipped by Agropecuaria Montelibano, San Lorenzo, Valle, Honduras". All boxes also contain the Chestnut Hill Farms logo.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 13:05:30 -0500 (CDT)
Subject: Chiquita Brands International, Inc. Recalls Whole Cantaloupes Grown by Agropecuaria Montelibano, Honduras, Due to Possible Health Risk (March 27)
Chiquita Brands International, Inc. Recalls Whole Cantaloupes Grown by Agropecuaria Montelibano, Honduras, Due to Possible Health Risk (March 27)
Fri, 28 Mar 2008 12:48:00 -0500
Chiquita Brands International, Inc. today announced a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano in Honduras. The product was distributed to customers nationwide and is being recalled because they have the potential to be contaminated with Salmonella.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 14:40:59 -0500 (CDT)
Subject: Recent Device Approvals Update: FreeStyle Navigator® Continuous Glucose Monitoring System
You are subscribed to Recent Device Approvals for U.S. Food & Drug Administration (FDA). Information about the FreeStyle Navigator® Continuous Glucose Monitoring System has recently been posted to the FDA website, and is now available.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 15:05:19 -0500 (CDT)
Subject: FDA Seeks Civil Penalties from Calif. Device Maker
FDA Seeks Civil Penalties from Calif. Device Maker
Fri, 28 Mar 2008 14:19:00 -0500
The U.S. Food and Drug Administration (FDA) today announced it is seeking a 2.2 million dollar penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 18:04:53 -0500 (CDT)
Subject: Spokane Produce Recalls Cut Cantaloupe Products Because of Possible Product Risk (March 28)
Spokane Produce Recalls Cut Cantaloupe Products Because of Possible Product Risk (March 28)
Fri, 28 Mar 2008 17:06:00 -0500
Spokane Produce, Inc. of Spokane, Washington is recalling Garden Patch, Yokes, and Rosauers Classic labels of various products of fresh cut and cut fruits containing cantaloupe, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Message: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 23:05:29 -0500 (CDT)
Subject: Voluntary Recall on Honduran Cantaloupes Due to Potential Health Concerns (March 28)
Voluntary Recall on Honduran Cantaloupes Due to Potential Health Concerns (March 28)
Fri, 28 Mar 2008 18:59:00 -0500
Dole Fresh Fruit Company, a subsidiary of Dole Food Company, Inc., has voluntarily recalled all Honduran Cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras.
Message: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 08:08:45 -0500 (CDT)
Subject: FDA Update for Healthcare Professionals
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent product safety information. 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
Communication about an Ongoing Safety Review Regranex (becaplermin) (Mar 27)
FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers.
This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers.
FDA will communicate its conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed. The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program. For additional information about the product, the studies, and how to report adverse events, please visit http://www.fda.gov/cder/drug/early_comm/becaplermin.htm.
Analyses of data collected through February 1, 2007 examined the risk of myocardial infarction (heart attack) in patients taking selected HIV drugs from the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, stavudine, abacavir, didanosine, and lamivudine. The analyses, specifically, describe the relative risk of heart attack among cumulative use, recent use (currently using or use within the past 6 months), and past use (last use greater than 6 months ago) of these drugs.
These analyses showed that recent use of abacavir or didanosine was associated with an increased risk of heart attack. Patients taking either of these drugs had a greater chance of developing a heart attack than patients taking other medications. The risk did not appear to increase over time, but remained stable and appeared to be reversible after abacavir or didanosine were stopped.
FDA currently believes analyses conducted with D:A:D Study data are incomplete; no analyses were conducted evaluating the risk of heart attack when patients take tenofovir or emtricitabine, two other drugs in the class of NRTIs. However, FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until this evaluation is complete, healthcare providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine.
The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with these products to the FDA MedWatch reporting program. For additional information about this communication including study details and how to report adverse events, please visit http://www.fda.gov/cder/drug/early_comm/abacavir.htm
Early Communication About an Ongoing Safety Review of Montelukast (Singulair) (Mar 27)
Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).
FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA.
Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood. For additional information including how to report adverse events associated with this product, please visit http://www.fda.gov/cder/drug/early_comm/montelukast.htm
FDA Alert - Darunavir Ethalolate (marketed as Prezista) Information (Mar 21)
FDA and Tibotec Therapeutics have reviewed information from clinical trials in which Prezista was administered and from postmarketing adverse event reports of hepatotoxicity in patients taking Prezista. While causality is not firmly established, an association between Prezista and hepatotoxicity is suspected.
Prezista, a protease inhibitor indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, is co-administered with ritonavir, an antiretroviral drug associated with hepatotoxicity. In general, HIV antiretroviral medications are associated with liver enzyme elevations, however, for some medications, an association with hepatotoxicity is more firmly established.
Healthcare providers should conduct appropriate hepatic laboratory testing prior to and after starting patients on Prezista. Patients should promptly seek medical attention if they experience unexplained fatigue, anorexia, nausea, jaundice, abdominal pain or dark urine. Healthcare professionals should consider interrupting or discontinuing Prezista if evidence of new or worsening liver injury arises. For additional information including links to Prezista prescribing information, please visit http://www.fda.gov/cder/drug/infopage/darunavir/default.htm
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
Message: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 28 Mar 2008 13:13:04 -0500 (CDT)
Subject: MedWatch - Recall of Total Body Formula dietary supplements due to reports of hair loss, muscle cramps, diarrhea, joint pain and fatigue
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The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products, Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#TotalBody
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