FDA NEWS

FDA Approves Amitiza for IBS-C
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.

Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx� Stent Graft System
In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx� Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ...

FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Sentinel System to Monitor Medical Product Safety
FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance.

Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.

Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter
FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ...

A Guide to Drug Safety Terms at FDA
This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug.