FDA NEWS

Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available.

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA investigating TNF blockers and cancer risk in children and young adults.

FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information.

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.

Mommy's Bliss Nipple Cream
Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

Current Drug Shortage: Neupro (rotigotine transdermal system)
UCB is preparing to recall all Neupro lots in the U.S. by May 2008

Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg
Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets.