Category: FDA Drug Safety Oversight
-
Critics Say FDA Drug-safety Oversight Needs To Be More Independent
Big Pharma Tells IOM Panel, However, No Major Changes Are Needed In the January 12, 2006 edition of the New England Journal of Medicine (NEJM), an article by Wayne A. Ray and C. Michael…
-
Elidel And Protopic Will Finally Get Black-box Warnings
FDA: Eczema Products Must Warn About Increased Cancer Risks On January 19, 2006 the FDA announced that two eczema products, Elidel and Protopic, must have a "black-box" warning placed on their package insert, or…
-
The Politics Of Tort Reform Bogs Down FDA’s Regulatory Action
New Drug-labeling Rule Bears The Load Of Bush Appointees’ Ideology According to a January 14, 2006 article in The Wall Street Journal (WSJ), the FDA "is preparing to declare that federally approved medication labels…
-
FDA Wants New Safety Studies For Adderall, Other ADHD Drugs
Reports Of Serious Adverse Events Involving Sudden Death, Heart Attack, and Stroke Reports of sudden deaths, heart attacks, and strokes in both children and adults taking drugs to treat attention deficit hyperactivity disorder (ADHD)…
-
FDA Consumer Magazine: Prescription Drug News and Information, And More
Offers Broad Coverage, Including Reports On Current FDA Regulatory Activites FDA Consumer magazine is available online at no cost, while the traditional paper version of this federal government publication has a $14 annual subscription…
-
Many “Canadian” Online Drugs Are, In Fact, Not From Canada
FDA Says These Are "Drugs Of Dubious Origin, Safety, And Efficacy" In mid-December 2005 the FDA reported that the majority of Web sites believed to be Canadian pharmacies selling prescription drugs manufactured in Canada…
-
FDA’s David Graham Says U.S. Drug Safety System No Better in 2005
Graham Criticizes Agency’s Performance During The Year Since Vioxx Recall In November 2004 David Graham, associate director for science and medicine at the FDA’s Office of Drug Safety, criticized the FDA’s drug oversight practices…
-
Consumer Reports Identifies 12 Unsafe Drugs To Be Used With Caution
January 2006 Edition of Magazine Addresses Drug-safety System Problems The January 2006 edition of Consumer Reports magazine includes an investigative report entitled, "Prescription for Trouble". This Consumer Reports article identifies 12 prescription drugs taken…
-
Did GlaxoSmithKline Mislead The FDA As Regards Asthma Drug Serevent?
Consumer Group Public Citizen Allegation In Medical Journal The Lancet In an early October 2005 edition of The Lancet, a British medical journal, a published letter by the American consumer group Public Citizen accused…
-
Serevent, Advair, and Foradil: Increased Risk of Severe Asthma Episodes and Death
FDA MedWatch Alert About LABA Asthma Drugs Follows Health Canada Warning In October 2005 On November 18, 2005 the FDA issued a MedWatch alert regarding Serevent, Advair, and Foradil to inform doctors and patients…