Update: 1
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
Information about CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA) has recently been updated, and is now available.
Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation - 4/9/2008
Update : 2
Subject: Cracker Barrel Issues Allergy Alert on Mislabeled Chocolate-Covered Peanuts and Almonds (April 9)
Cracker Barrel Issues Allergy Alert on Mislabeled Chocolate-Covered Peanuts and Almonds (April 9)
Thu, 10 Apr 2008 10:15:00 -0500
Cracker Barrel Old Country Store, Inc. is recalling 5-ounce bags of chocolate-covered almonds and 5-ounce bags of chocolate double-dipped peanuts because the packaging is labeled incorrectly.
Update : 3
Subject: CDER New 4/9 - 10/2008
| ||||||||||||
April 10, 2008
- Bioresearch Monitoring Information System (BMIS) (updated)
- Cyber Letters (updated)
- FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic.
- New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
- Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
- Pfizer informs healthcare professionals and patients of updated safety information in the labeling for Exubera, a short-acting insulin. MedWatch Safety Information
- Schwarz Pharma recalls Neupro, a transdermal delivery system used to treat early stage Parkinson’s disease, at the end of April. MedWatch Safety Information
April 9, 2008
- BPCA/Pediatric Exclusivity Statistics:
- Breakdown of Requested Studies Report (updated)
- Spectrum of Diseases/Conditions (updated)
- Written Requests Issued (updated)
- Written Requests Statistics (updated)
- Pediatric Exclusivity Granted (updated)
- Cubist Pharmaceuticals, Inc. informs healthcare professionals that a potentially significant impurity has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MedWatch Safety Information
- Dissolution Methods Database (updated)
- Drugs@FDA Downloadable Data Files (updated)
- Research in the Division of Drug Marketing, Advertising, and Communications (DDMAC)
Update : 4
Subject: FDA MedWatch- CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid)-Possible Development Of Progressive Multifocal Leukoencephalopathy
  |
FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information. As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public.
Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Communication About an Ongoing Safety Review regarding this issue and prior MedWatch alerts regarding these products at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Apr 2008 14:59:02 -0500 (CDT)
Subject: FDA MedWatch - Total Body Formula, Total Body Mega Formula found to contain hazardous levels of selenium
| |
[UPDATE] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.
Read the complete MedWatch 2008 safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#TotalBody
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
