July 8, 2008 – 4:24 pm | One Comment

In a move sure to stir controversy, the American Academy of Pediatrics (AAP) recommended on Monday that a more aggressive approach to treating high cholesterol in children should be implemented, even if it means prescribing …

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Articles in FDA

FDA Wants Stronger Acetaminophen Warnings
June 3, 2009 – 2:42 pm | No Comment

Most Americans assume over-the-counter (OTC) painkillers are relatively safe and that dosage limits listed on their labels are mere recommendations, OK to ignore if the pain doesn’t immediately go away.  This, unfortunately, is not the …

FDA Says 14 Unapproved Narcotic Painkillers Must Go
April 11, 2009 – 3:52 pm | One Comment

Almost 2% of all prescriptions filled in the United States are for drugs that never got approval from the US Food and Drug Administration (FDA).  Fourteen of these unapproved drugs are for narcotic painkillers that …

Doctor Accused of Fabricating Drug Safety Data
March 17, 2009 – 1:31 pm | One Comment

The American public relies on the US Food and Drug Administration (FDA) to ensure nothing but the safest drugs are prescribed but the FDA relies on medical research scientists to provide the background data in …

FDA Approves First New Gout Drug in 40 Years
February 16, 2009 – 11:51 pm | 10 Comments

It’s been 40 years since the US Food and Drug Administration (FDA) approved a new drug for treating gout but the new drug, Uloric (febuxostat), has just passed the test, according to Takeda Pharmaceuticals, maker …

Eli Lilly Gets $1.4B Fine for Zyprexa Off-Label Marketing
February 6, 2009 – 11:18 am | 3 Comments

The US Justice Department has ordered Eli Lilly and Company to pay penalties totaling $1.415 billion for off-label marketing of its drug, Zyprexa.  The company pleaded guilty on January 30 to a misdemeanor charge of …

List of Drugs Getting FDA Safety Review
February 6, 2009 – 7:27 am | One Comment

The US Food and Drug Administration (FDA) has released a list of dozens of drugs for which it is conducting safety reviews after concerns over their side effects and potential complications have been raised.  Some …

FDA Says No To Labels On Food From Genetically Engineered Animals
January 23, 2009 – 6:26 am | 2 Comments

In a recent announcement, the US Food and Drug Administration (FDA) says there is no reason to require labels for foods made from animals that were genetically engineered and sold to American consumers.  The animals …

Scientists Urge Restructure of ‘Fundamentally Broken’ FDA
January 9, 2009 – 6:27 am | One Comment

A group of the nation’s top scientists sent a letter on Wednesday, January 7, to the transition team for President-elect Barack Obama in which they urge a restructure of the US Food and Drug Administration …

FDA Criticized for Slow Approvals but Allows 21 New Drugs This Year
December 21, 2008 – 11:39 am | One Comment

No doubt, 2008 has been a rough year just about everywhere, with slings and arrows targeting everybody from an ambitious plumber to the president.  Somewhere in the middle is the US Food and Drug Administration …

Colonoscopy Prep Drugs Get New Black-Box Warnings
December 12, 2008 – 6:18 am | One Comment

For many people, confronting a colonoscopy is a test of both will and modesty but there is no doubt it is a life-saving procedure.  Preparation for this procedure starts early and involves both the body …