FDA News

Five products marketed as dietary supplements contain undeclared substances considered to be steroids.

– Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheathTM Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.

The U.S. Food and Drug Administration (FDA) and Everyday Health today announced a collaboration that will expand the delivery of the agency’s vital consumer health information to the 30 million unique users who visit Everyday Health each month.

Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole.

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older.

Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.

Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death.

Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein.

The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) today released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems.