FDA NEWS

Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death.

Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue)
Covidien now has Lymphazurin 1% injection available.

Drug Shortage: Digitek (digoxin tablets, USP)
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website.

Combating Antibiotic Resistance
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics.

Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
Dear Healthcare Professional Letter is available.

New Type of Latex Glove Cleared
FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex.

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.

Cardinal Alcohol-Free Mouthwash
Product recalled because of the presence of Burkholderia cepacia.

Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.

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.

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