FDA Tagged Articles

FDA plans 2-day metal hip device review
Posted: April 7, 2012 Pharmaceutical

Responding to growing concerns over complications associated with metal-on-metal hip implant devices, the U.S. Food and Drug Administration (FDA) said it has planned a two-day review of the devices in June that could result in tougher regulations.

Lap-bands not thoroughly tested before approved for use
Posted: April 6, 2012 Pharmaceutical

Two new studies published in the New England Journal of Medicine are touting the benefits of bariatric surgery in obese patients for the quick lowering of blood sugar levels that has resulted in the reduction or elimination of patents’ need

Consumer Reports takes aim at FDA’s device approval process
Posted: April 5, 2012 Pharmaceutical

Janet Holt’s doctor told her that surgery to remove her uterus and insert a bladder lift would have her out of work for just two weeks. After that, she should be able to return to work on the family’s cattle

FDA to scrutinize metal-on-metal hips in June
Posted: April 4, 2012 Pharmaceutical

Signaling more trouble for metal-on-metal hip devices and their manufacturers, the U.S. Food & Drug Administration (FDA) announced it has planned a 2-day review of the controversial medical devices, which have become the subject of thousands of personal injury lawsuits

Graphic anti-smoking ad campaign seems to be working
Posted: April 3, 2012 Product Liability

More than twice the number of people called an anti-smoking hotline last week after a series of graphic ads depicting horrifying consequences of cigarette use hit billboards, newspapers, magazines, radios and televisions across the country. The ads are part of

FDA missed warning signs on metal-on-metal artificial hips
Posted: April 2, 2012 Pharmaceutical

Dr. Stephen Tower, an orthopaedic surgeon from Anchorage, Alaska, knew the artificial hip device he wanted when he required hip replacement surgery for his arthritic hip. He chose the ASR XL, a metal-on-metal device made by DePuy Orthopaedics, a subsidiary

Trials on experimental type 2 diabetes drug dropped after dismal results
Posted: April 2, 2012 Pharmaceutical

Pharmaceutical company Targacept, Inc. is giving up on its experimental type 2 diabetes drug known as TC-6987, after it showed less than desirable results in phase II clinical trials. The drug was designed to measure changes in fasting glucose, a

New algorithm detects adverse reactions caused by drug combinations
Posted: March 30, 2012 Pharmaceutical

A new algorithm developed by researchers to search through the U.S. Food and Drug Administration’s (FDA) enormous and complex record of drug interaction data reveals what can happen when patients take prescription drugs in combination.

Health Canada issues stronger warnings for blood thinner Pradaxa
Posted: March 28, 2012 Pharmaceutical

Health regulators in Canada have issued a warning on the new blood thinner Pradaxa, sold in Canada as Pradax. The new safety label will warn that the risk of internal bleeding events may be increased among patients with kidney problems,

Group offers support network for girls injured by Gardasil
Posted: March 8, 2012 Pharmaceutical

Girls who believe they have been harmed by Merck’s human papillomavirus (HPV) vaccine and their families shouldn’t have to feel alone when dealing with the devastating effects many people believe the drug can have, thanks to an international outreach of