Category: FDA Drug Safety Oversight
-
Cholesterol Drug Zetia May Cause Serious Liver Injury Including Hepatitis And Liver Failure
Health Canada First Raised This Zetia Safety Issue In February 2005; News Reporter Discovers In December 2007 That Information Known By Merck and Schering-Plough About These Zetia Side Effects May Have Been Withheld (Posted…
-
FDA Expected To Comment On Its Safety Evaluation Of Nexium And Prilosec In December 2007
Agency’s Follow-Up On Its August 2007 "Early Communication" About These Heartburn Drugs Is Late, But Just In Time For Christmas Dinner (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, in early August 2007…
-
Mixed Reactions To Avandia’s Revised Warning In November 2007 About Risk Of Heart Attacks
Drug Safety Experts And FDA Officials Discuss Avandia And The New Black-Box Warning (Posted by Tom Lamb at DrugInjuryWatch.com) On November 14, 2007 the FDA issued a news release entitled "FDA Adds Boxed Warning…
-
November 2007 FDA Advisory Panel Recommends That Serevent And Advair Get Stronger Warnings About Use By Children
Some Panel Members Want Serevent Withdrawn From Market; FDA And GSK Say Asthma Drug Recall Is Not Appropriate (Posted by Tom Lamb at DrugInjuryWatch.com) On November 28, 2007 an FDA pediatric advisory panel recommended…
-
FDA Report Says Popular Asthma Drugs Serevent And Advair May Have Deadly Side Effects For Some Children
November 2007 Advisory Panel Meeting To Consider Safety of These Glaxo Drugs As Well As Novartis’ Foradil (Posted by Tom Lamb at DrugInjuryWatch.com) An October 24, 2007 FDA staff report about Serevent (SUBJECT: 1-year…
-
FDA Announces In November 2007 That It Will Investigate Possible Link Between Maxipime And Increased Risk Of Death
A Medical Journal Article Published In May 2007 Suggested This Emerging Drug Safety Issue; Why Was There A Six-Month Delay In Starting This FDA Investigation? (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-November 2007…
-
Will New Black Box Warning About Heart Attacks Lead GlaxoSmithKline To Withdraw Avandia From Market?
One Wonders Whether GSK Might Do A "Soft" Recall Of Its Embattled Diabetes Drug, As Was Done By BMS With Serzone And Tequin In Recent Years (Posted by Tom Lamb at DrugInjuryWatch.com) Avandia (rosiglitazone)…
-
Trasylol Sales In U.S. And Canada Suspended Temporarily By Bayer In Early November 2007
Market Withdrawal Or Recall Of Trasylol Seems Possible As Bayer Waits For Final Data From Halted BART Study (Posted by Tom Lamb at DrugInjuryWatch.com) On November 5, 2007 the FDA announced and Health Canada…
-
New Information From FDA On Alleged Problems With Ketek Safety Study 3014
October 2007 FDA Letter Says Aventis Did Not Follow Regulations And Statutory Requirements; Company Contends Study Conducted In Good Faith (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA posted on…
-
Congressman Waxman Sends A Letter To FDA Requesting Medtronic Sprint Fidelis Information
Committee on Oversight and Government Reform Wants To Know What The FDA Knew About Defibrillator Lead Wire Fractures And When They Knew It (Posted by Tom Lamb at DrugInjuryWatch.com) On October 22, 2007, as…