Tougher Avandia Warning is Urged

The Food and Drug Administration wants GlaxoSmithKline PLC to add the strongest form of safety warning about heart-attack risk to the label of its diabetes drug Avandia.

Congress Questions FDA about Medtronic Recall

One week after a Medtronic Defibrillator Lead recall was issued, the U.S. Congressional Committee on Oversight and Government Reform wants to know what the FDA knew and when they knew it.

FDA Eyes New Boxed Warning on Glaxo's Avandia-WSJ

U.S. Food and Drug Administration officials are pushing for a "black box" warning of the risk of heart attack on GlaxoSmithKline Plc's diabetes drug Avandia, the Wall Street Journal reported on Wednesday, citing unnamed sources.

Medtronic Defibrillator Sprint Fidelis Lead Recall

This month's Medtronic defibrillator Sprint Fidelis lead recall has prompted Congress to initiate of review of the procedures the Food & Drug Administration (FDA) uses to test heart device components.

Health Officials Contact Winnipeggers Over Defibrillator Troubles

The Winnipeg Regional Health Authority is contacting about 100 people in the Winnipeg area who have defibrillators with potentially defective wires attached to them.

Heart Lead Recall May Pose More Risk for the Young

The defibrillator leads pulled off the market this week by Medtronic Inc. may pose a higher risk of fracture in younger adults and children, a population for whom the devices were particularly popular in part because of their small diameter.

At the Heart of an Implant Component Recall

The FDA and heart device maker Medtronic told doctors to stop using a particular component the wire lead of Medtronic's latest generation of implanted heart defibrillators.

Defective Medtronic Defibrillator Lead Problems Known for Months

Reports of frequent fracturing of Sprint Fidelis leads on Medtronic implantable defibrillators had been piling up for months, but the company only chose to withdraw the defective leads earlier this week.

V.A. is Limiting Use of Diabetes Drug

The Department of Veterans Affairs has decided to severely limit the use of Avandia, the once-popular drug for Type 2 diabetes, delivering another blow to the product's maker, GlaxoSmithKline.

Avandia Removed from Veteran Affairs Drug Formulary

Avandia will no longer be a drug of choice for the Department of Veterans Affairs (VA). The decision to remove rosiglitazone, known by the brand name Avandia, from the VA drug formulary comes after months of debate over the diabetes medication's safety.