FDA News

FDA Warns of Liver Injury From Muscle-Building Supplement

The Food and Drug Administration is warning consumers to avoid dietary supplements sold by a Las Vegas company because they may contain anabolic steroids that can cause liver damage. The agency said it is investigating Tri-Methyl Xtreme supplements after three …

FDA Drug Approvals Reached 18-Year High in 2014

The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency’s annual tally of drug approvals to its highest level in 18 years. The 2014 approval list includes …

FDA Says Not Enough Evidence to Drop Chantix Warning

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. The twice-a-day tablet has carried the Food and Drug Administration’s strongest warning label, known as …

Major Changes Coming to FDA Revised Food Safety Rules

The Food and Drug Administration on Friday revised sweeping food safety rules proposed last year after farmers complained that the regulations could hurt business. The new proposals would relax water quality standards and allow farmers to harvest crops sooner after …

FDA Warns of Compounded Drug Recall by Texas Pharmacy

The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination. The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. …

FDA Warns of Dangers Associated With Powdered Caffeine

The Food and Drug Administration is warning consumers to avoid pure powdered caffeine sold on the Internet after the death of an Ohio teen. Even a teaspoon of the powder could be lethal – it is equivalent to 25 cups …

New Rules Proposed by FDA to Keep Foods Safe During Transport

The Food and Drug Administration is proposing new rules to keep food safe while it’s transported. The rules announced Friday are part of a sweeping food safety law signed by President Barack Obama in 2011. They would require many larger …

Unreported Robot Surgery Injuries Open New Questions for FDA

When Sheena Wilson, 45, underwent robotic surgery for a hysterectomy in May, she didn’t know the Intuitive Surgical Inc. system used by her doctor was previously tied to a variety of injuries for the same procedure. Her rectum was badly …

FDA Seeks Tougher Rules on Antibacterial Soaps

The federal government said Monday it has no evidence that antibacterial chemicals used in liquid soaps and washes help prevent the spread of germs, and it is reviewing research suggesting they may pose health risks. Regulators at the Food and …

Intuitive Warns Surgeons of Friction With Robotic Surgical Arms

Intuitive Surgical Inc., the maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some of its devices could cause the unit to stall, the second warning the company has issued about its products …