Category: FDA Drug Safety Oversight
-
Procrit, Epogen, And Aranesp: New “Black Box” Warnings Only First Part Of FDA’s Safety Re-evaluation
Popular Anemia Drugs Have Increased Risk Of Death, Blood Clots, Strokes, And Heart Attacks, Especially In Context Of Off-label Prescribing And Use (Posted by Tom Lamb at DrugInjuryWatch.com) On March 9, 2007 the FDA…
-
Big Pharma Has Its Way With The FDA Once Again As Regards Drug Safety
Agency Flops And Drops Its Proposed Drug Watch Site, Which Was Intended To Provide Early Warning About Emerging Unsafe Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2005 the FDA announced that they…
-
Allegation By FDA Whistleblower David Ross Adds To Controversy Over Antibiotic Ketek
Former FDA Scientist Claims Agency Superiors Downplayed His Pre-approval Concerns About Safety of Ketek (Posted by Tom Lamb at DrugInjuryWatch.com) In a February 8, 2007 Bloomberg article, Justin Blum reported on his interview with…
-
Will FDA Restrict Use Of Ketek And Put Increased “Black Box” Warning On Sanofi-Aventis Antibiotic?
FDA Advisory Panel: Ketek Side Effects Risks Outweigh Benefits For Bronchitis And Sinusitis; Urges Patient Medication Guide When Used For Pneumonia In mid-December 2006, after two days of hearings, an FDA advisory panel recommended…
-
New Birth Control Patch Warnings In Canada About Being Overweight, Sauna Or Whirlpool Heat
No Similar Changes To Ortho Evra Label In U.S. As Of Early December 2006 On November 23, 2006 Health Canada released a drug safety alert — which consisted of a so-called "Dear Doctor" letter…
-
David Graham’s NEJM Letter Concerning Sanofi-Aventis Antibiotic Ketek
Suggests That Reports Of Acute Liver Failure Support A Ketek Recall A November 22, 2006 Reuters article by Susan Heavey reports on the latest development as regards the continuing controversy surrounding Ketek (telithromycin), an…
-
Is The End Near For Sanofi-Aventis Antibiotic Ketek?
December 2006 FDA Meeting Will Focus On Side Effect Risks, While Fraud Investigation Continues A November 14, 2006 Associated Press (AP) article was the first to report that in December 2006 the FDA will…
-
Preventing Serious Adverse Drug Reactions In The U.S. (Part of Series: ADRs in US)
Part Two: FDA-MIT Database Project Should Improve Drug-safety Monitoring In our first part to this series, we took a look at the extent of serious adverse drug reactions (ADRs) in the U.S. In this…
-
FDA Approves New, Stronger Warnings For ADHD Drugs
Sudden Deaths, Strokes, And Heart Attacks In Adults At Usual Doses Several drugs to treat attention deficit hyperactivity disorder (ADHD) — including GlaxoSmithKline (GSK) Plc’s Dexedrine, Novartis AG’s Ritalin, Johnson & Johnson’s Concerta, and…
-
Ketek Allegedly “More Toxic Than Most Other Drugs”
Dr. David Graham At FDA Wants An "Immediate Withdrawal" Of Ketek On the morning of July 19, 2006 a National Public Radio (NPR) news piece about Ketek brought our attention back to this increasingly…