On August 3, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan, active ingredient fluconazole, may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.
FDA Drug Safety Podcast for Healthcare Professionals: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients
On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography, or PET, scans. The manufacturer, Bracco Diagnostics, Inc. has decided to voluntarily recall CardioGen-82.
FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) drug label now contains updated efficacy and safety information
On July 22, 2011, the Food and Drug Administration issued a Drug Safety Communication informing that public that FDA has approved an updated drug label for the smoking cessation aid Chantix, active ingredient varenicline, to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking — those with cardiovascular disease and those with chronic obstructive pulmonary disease, or COPD.
FDA Drug Safety Podcast for Healthcare Professionals: FDA Drug Safety Podcast for Healthcare Professionals: Serious CNS reactions possible when linezolid (Zyvox.) is given to patients taking certain psychiatric medications
On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of reports of serious central nervous system reactions when the drug methylene blue is given to patients taking serotonergic psychiatric medications.
Best Food Cash & Carry Issues Allergy Alert On Undeclared Sulfite In Deer Brand “Raisin Golden�
Best Food Cash & Carry Inc. of Maspeth, NY is recalling its 14 oz Raisin Golden packages of Deer Raisin Golden because they contain undeclared sulfite. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
FDA announces new staff training for medical device reviewers
The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH).
Quaker Oats Issues Voluntary Recall Of Specific 8-Count Quaker Chewy Smashbar Graham Pretzel Snack Bars Due To Undeclared Milk Allergen
Quaker Oats Company, a division of PepsiCo, has issued a voluntary recall of 8-count Quaker Chewy Smashbar Graham Pretzel snack bars due to an undeclared milk allergen that is not noted on the label.
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FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards
FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards
King International Recalls the Shoulderflex Massager
In cooperation with the Food and Drug Administration (FDA), King International LLC Is initiating a recall of the Shoulderflex massager due to a report of a strangulation and death. Consumers, retailers and catalog sellers are being advised to immediately stop using Shoulderflex massagers, and to safely dispose of them in the trash.
Pure Encapsulations, Inc. Issues Allergy Alert On Undeclared Egg Allergen In Prenatal Nutrients
Pure Encapsulations of Sudbury, Massachusetts is voluntarily recalling PreNatal Nutrients lot number 3560111, because it may contain undeclared egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.