Tag: FDA
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Blood Pressure Medication Benicar (Olmesartan) Might Be Unsafe For Some Patients
Two Clinical Studies Find Patients With Type 2 Diabetes Taking Benicar Had Higher Rate Of Death From A Cardiovascular Cause (Posted by Tom Lamb at DrugInjuryWatch.com) On June 11, 2010 the FDA announced that…
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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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Is Bayer Warning Or Attacking With Its New YAZ / Yasmin Package Insert, Or Label, In The U.S.
Bayer Says YAZ / Yasmin Safety Profile Is Comparable To Older Birth Control Pills, But European Regulators See Possible Increased Risk Of Blood Clot Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________________________ UPDATE: "Bayer…
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New Extensively Documented Case Report About Patient With Probable Byetta-Induced Pancreatitis
Numerous Factors, Including Temporal Relation Of Symptoms To Drug Use Dates And A Naranjo Scale Score Of 7/9, Strongly Suggest Byetta Caused This Case Of Acute Pancreatitis (Posted by Tom Lamb at DrugInjuryWatch.com) On March 25,…
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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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Focus On Fosamax
________________________________________________________ Free Fosamax Case Evaluation The information you provide to us for this Free Case Evaluation will be treated as strictly confidential. You will get a reply from us no later than the next business…
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Generic Drug Manufacturer ETHEX Corp. Is Being Shut Down By KV Pharmaceuticals
Troubled Company Pleads Guilty To Criminal Charges, Pays $27.6 Million In Fines And Restitution For Its Conduct Related To Quality-Control Issues (Posted by Tom Lamb at DrugInjuryWatch.com) We last wrote about the troubled generic…
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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…