Category: FDA Drug Safety Oversight
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Sanofi-Aventis Sending “Dear Doctor” Letter About Ketek Label Changes
Bolded Warning, But Not "Black Box", For Liver Problems And Reports Of Deaths In late June 2006 Sanofi-Aventis SA announced that it had added a new bolded warning about the risks of liver failure…
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Antibiotic Ketek: FDA Staff Recommends “Black-box” Warning
As Of May 1, 2006 There Are 23 Reports Of Serious Liver Injury, Including 12 Cases Of Liver Failure, In U.S. After finding the antibiotic Ketek (telithromycin) has been associated with 12 cases of…
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What Is The Better Way To Improve Safety Of New Prescription Drugs?
Five Points For Consideration In May 2006 Circulation Editorial By Jerry Avorn, M.D. In May 2006 the medical journal Circulation published "Evaluating Drug Effects in the Post-Vioxx World — There Must Be a Better…
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FDA’s Approval Of Antibiotic Drug Ketek Under Scrutiny
WSJ Investigative Article Revealed Faulty Data And Improper Record-keeping For Key Drug Study As reported in a May 2, 2006 article by Wall Street Journal reporter Anna Wilde Mathews, Senator Charles Grassley (R-Ill.) as…
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Celebrex Ads Return Despite Continuing Heart Risk Controversy
Celebrex DTC Advertising Was Suspended By Pfizer During 2005 At Request Of FDA Some people may have noticed recently that Pfizer Inc. is advertising its blockbuster drug Celebrex, again, in full-page color ads appearing…
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GAO Report Says FDA’s Postmarket Drug-Safety Monitoring Is Not Effective
FDA Fails To Timely Detect Emerging Unsafe Drugs Because Of Agency Flaws And Limitations A Government Accountability Office (GAO) report released on April 24, 2006 reached the conclusion that the FDA "lacks a clear…
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Marketing Group Petitions FDA To Change Drug Advertising Rules
Warnings About Specific Side Effects Would Be Eliminated, And Replaced By Boilerplate Language On March 31, 2006 the Coalition for Healthcare Communication — a group of drug advertising agencies and public relations companies —…
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Whistleblower David Graham Discusses Problems With The FDA
In-depth Interview Of This Top FDA Insider From 2005, In Seven Parts In August and September 2005 Dr. Joseph Mercola — an osteopathic physician, also known as a DO — published on his web…
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Concern Expressed About Heart Risks From Adderall, Ritalin, Other ADHD Drugs
Early Release of Dr. Nissen’s NEJM Article: "ADHD Drugs and Cardiovascular Risks" Cardiologist Steven E. Nissen believes that Shire Plc’s Adderall, Novartis AG’s Ritalin, and other drugs used to treat attention deficit-hyperactivity disorder (ADHD)…
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Drug Safety Oversight Board Needs Improvements, Says Leading FDA Adviser
Chairman Dr. Peter Gross Suggests Two Changes: Open Meetings And Public Representatives In mid-February 2006 Dr. Peter Gross, the outgoing chairman of the FDA’s drug-safety and risk-management advisory committee, said that the agency’s relatively…