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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 05:57:32 -0600 (CST)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: February 6, 2008 |
The following new items were added to the CDRH web pages on February 5, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing. |  |  |
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking. | | |
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program. | | |
| FDA Approves Drug-Eluting Stent for Clogged Heart Arteries | | |
| Summary Information for: SJM Epic™ Valve and SJM Epic™ Supra Valve | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 09:14:32 -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: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 14:06:38 -0600 (CST)
Subject: FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine
FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine
Wed, 6 Feb 2008 12:28:00 -0600
The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 16:04:18 -0600 (CST)
Subject: FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food
FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food
Wed, 6 Feb 2008 14:46:00 -0600
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations announced that two Chinese nationals and the businesses they operate, along with a U.S. company and its president and chief executive officer, were indicted by a federal grand jury today in separate but related cases. The indictments are for their roles in a scheme to import products purported to be wheat gluten into the United States that were contaminated with melamine. These products were used to make pet food.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 16:04:22 -0600 (CST)
Subject: Generic Fosamax Approved
Generic Fosamax Approved
Wed, 6 Feb 2008 14:56:00 -0600
The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 14:37:29 -0600 (CST)
Subject: FDA Information Update- February 6, 2008
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, product approvals, upcoming public meetings, and other information that might be of interest. 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
FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.
· On February 1, FDA held a media briefing on this topic. A replay of the briefing is available until February 16 by dialing toll free 866-888-566-0452.
FDA issued new information to health care professionals to alert them about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions.
FDA Warns Public of Contaminated Syringes (Jan 25)
FDA announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of
FDA Issues Early Communication about an Ongoing Review of Vytorin (Jan 25)
FDA issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study – the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) – on this cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.
The February edition of FDA Patient Safety News (PSN) is now available.
Patient Safety News is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program. You may have already received notification of some of these safety issues through the MedWatch Listserv. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
In the February Edition of FDA Patient Safety News, the producers chose to repeat some of the most important safety issues that continue to pose a public health problem. The month and year that the story first aired is in parentheses at the end of the story headline.
Stories in the February 2008 edition include:
- Helping Patients Avoid Counterfeit Drugs over the Internet (September 2007)
- Safe Use of Pneumatic Tourniquet Cuffs (April 2007)
- Avoiding Accidental Overdoses when Methadone is Prescribed for Pain (February 2007)
- Avoiding Burns from Electrodes and Cables during MRI Exams (February 2007)
- Severe Tissue Injury with IV Promethazine (December 2006)
FDA approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.
RECENT ANNOUNCEMENTS:
FDA announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout.
FDA Advises Seafood Processors About Ciguatera Fish Poisoning in the Northern Gulf of Mexico Near the Flower Garden Banks National Marine Sanctuary (Feb 5)
FDA issued a letter to seafood processors, advising them of recent illnesses linked to consuming fish carrying the ciguatera toxin, which has led to cases of ciguatera fish poisoning (CFP) in consumers. The toxic fish were harvested in the
President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports (Feb 4)
The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget—a 5.7 percent increase over the budget that the FDA received for the current fiscal year.
· On February 4, 2008, FDA held a stakeholder briefing on this topic. A replay of the briefing is available until February 11 by dialing toll free 800-756-2728.
Clarification of Recent FDA Initiatives Affecting OTC Drugs (Jan 25)
FDA recently announced implementation of two statutory amendments affecting over-the-counter (OTC) drug products. Because there has been some confusion expressed by stakeholders over these two actions, FDA is issuing this clarification.
UPCOMING MEETINGS:
DATE AND TIME: February 6, 8:00 a.m.
LOCATION:
CONTACT: Diem-Kieu Ngo, Center for Drug Evaluation and Research, 301-827-7001. More Information
Vaccines and Related Biological Products Advisory Committee
DATE AND TIME: February 20 and 21, 8:30 a.m.
LOCATION:
CONTACT: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), 301-827-0314. More Information
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
FDA CONSUMER HEALTH INFORMATION:
FDA Consumer Health Information page contains articles you may wish to use in your newsletter or link to from your organization's Web site. This month's feature article is Devices That Keep the Heart Beating. For this article and additional timely content, visit the Consumer Health Information page.
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: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 6 Feb 2008 15:06:48 -0600 (CST)
Subject: FDA MedWatch - Intravenous Colchicine- Product Associated With Fatal Effects Including Cardiac Events And Organ Failure
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FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form.
Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA News Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#colchicine
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