FDA NEWS

Morphine Sulfate 60 mg Extended Release Tablets
Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness.

Spring 2008 Drug Safety Newsletter
DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities.

Regranex (becaplermin) Gel
Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex.

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

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.