Category: FDA Drug Safety Oversight
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May 2010: New Safety Information For Xenical And Alli Regarding Cases Of Severe Liver Injury
FDA Had Been Investigating Reports Of Hepatotoxicity Involving Their Active Ingredient, Orlistat, For Past Year (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: EMA Decides Orlistat Benefits Worth the Risks The CHMP finalized its review…
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Serevent, Advair, and Foradil: Despite The Increased Risk of Severe Asthma Episodes and Death, Monotherapy Use Continues
Numerous Safety Warnings From FDA About These LABA Asthma Drugs Have Seemingly Been Ignored By Patients, According To New Medco Study (Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, back…
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April 2010: Senator Chuck Grassley Wants More Independence And Power For FDA Drug-Safety Reviewers
This Idea Has Been Circulating Since The 2005 Grassley-Dodd Bill, With No Real Movement Forward In Past Five Years (Posted by Tom Lamb at DrugInjuryWatch.com) Five years ago, on April 28, 2005, in the…
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Antibiotic Avelox Linked To Severe Liver Injury Side Effects, Again
Will The FDA Be The Last To Insist On Increased Warning; In Fall 2007 Bayer Updated Its Avalox Label In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) On March 22, 2010 Health Canada issued a press…
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March 2010: FDA Warns About Highest Dose Of Zocor Causing Myopathy And Rhabdomyolysis
Active Ingredient Simvastatin Is Found In Vytorin, With Zetia, And Simcor, With Niacin, Also (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________________________ UPDATE: FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor…
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FDA And Novartis Announce A Label Change For Iron Chelating Drug Exjade In Mid-February 2010
Includes A New "Black Box" Warning About Renal Impairment, Liver Failure, And Gastrointestinal Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-February 2010 the FDA and Novartis announced a change to the Prescribing Information…
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How Electronic Medical Records Review Might Help FDA Identify Unsafe Drugs Sooner
Study Says Using Such Data Would Have Resulted In Faster Safety Signal Detection For Increased Risk Of Heart Attacks With Avandia Use (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical journal article suggests…
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Fibromyalgia Drug Savella Should Be Pulled From Market, Says Public Citizen Group
January 2010 Petition Letter To FDA Is Sent One Year After The Medication Was Approved For Sale In U.S. (Posted by Tom Lamb at DrugInjuryWatch.com) On January 21, 2010 the Health Research Group arm…
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Should Meridia Remain On Market? FDA Says “Yes” (For Now At Least), European Drug Regulators Say “No”
Difference Of Opinion Suggests There Could Be A Possible Meridia Recall In U.S. Before The FDA Holds Its Public Advisory Meeting In September 2010(Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Abbott Pulls Meridia in U.S. Amid…
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Safety “Cloud” Gets Removed From Spiriva By FDA In January 2010
This COPD Medication Had Previously Been Possibly Linked To Stroke, Heart Attack, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) On January 14, 2010 the FDA issued a news release, "FDA Updates Earlier Guidance…