Michaelangelica Posted September 7, 2008 Author Report Share Posted September 7, 2008 An interestin service from the FDAhere is their Sept 5 warningsPotential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008Product Name: Active Ingredient (Trade)or Product Class Potential Signal of Serious Risk/New Safety InformationArginine Hydrochloride Injection (R-Gene 10) Pediatric overdose due to labeling / packaging confusionDesflurane (Suprane) Cardiac arrestDuloxetine (Cymbalta) Urinary retentionEtravirine (Intelence) HemarthrosisFluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusionHeparin Anaphylactic-type reactionsIcodextrin (Extraneal) HypoglycemiaInsulin U-500 (Humulin R) Dosing confusionIvermectin (Stromectol) and Warfarin Drug interactionLapatinib (Tykerb) HepatotoxicityLenalidomide (Revlimid) Stevens Johnson SyndromeNatalizumab (Tysabri) Skin melanomasNitroglycerin (Nitrostat) Overdose due to labeling confusionOctreotide Acetate Depot (Sandostatin LAR) IleusOxycodone Hydrochloride Controlled-Release (Oxycontin) Drug misuse, abuse and overdosePerflutren Lipid Microsphere (Definity) Cardiopulmonary reactionsPhenytoin Injection (Dilantin) Purple Glove SyndromeQuetiapine (Seroquel) Overdose due to sample pack labeling confusionTelbivudine (Tyzeka) Peripheral neuropathyTumor Necrosis Factor (TNF) Blockers Cancers in children and young adultsPotential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008Talk to your doctor before stopping any medication. Quote Link to comment Share on other sites More sharing options...
Michaelangelica Posted September 25, 2008 Author Report Share Posted September 25, 2008 Anti-Smoking Drug Chantix Causes Potentially Deadly Traffic Accidents Anti-Smoking Drug Chantix Causes Potentially Deadly Traffic Accidents Could anyone please help me keep up with this thread?I really can't keep up with all the latest information Quote Link to comment Share on other sites More sharing options...
Michaelangelica Posted June 5, 2009 Author Report Share Posted June 5, 2009 Great links DVKA full time job to keep up with it all!the FDA is now publishing alist of drugs they are rewiwng for safty infotheir resons and links to reports are herehttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/UCM082196This is the latest list although formatting will not paste overProduct Name: Active Ingredient (Trade)or Product Class Potential Signal of Serious Risk/New Safety Information Additional Information (as of May 7, 2009)Apomorphine (Apokyn) Psychiatric events FDA is continuing to evaluate this issue to determine the need for any regulatory action.Choriogonadotropin alfa (Ovidrel) Anaphylactic reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action.Clomiphene citrate (Clomid) Visual disorders FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.Clozapine orally disintegrating tablet (FazaClo) Deaths This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.Darifenacin (Enablex) and Solifenacin (Vesicare) Angioedema and other allergic reactions FDA is continuing to evaluate these issues to determine the need for any regulatory action.Drospirenone/ethinyl estradiol (Yasmin) Pancreatitis FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.Efavirenz (Sustiva) Birth defects involving the eye and face This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case.Efavirenz (Sustiva) labelingFibrin sealant, human (Evicel) Air embolism FDA is evaluating this issue to determine if labeling is adequate.Hydrochlorothiazide in combination products Skin reactions FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.Imiquimod cream (Aldara) Dysuria due to severe local reactions during use in the genital area This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB) (refer to Slide 24). The labeling will be updated to include this event.Modafinil (Provigil) and Armodafinil (Nuvigil) Serious skin reactions This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions. FDA is continuing to evaluate this issue to determine the need for any further regulatory action.Orlistat (Xenical, Alli) Hepatotoxicity FDA is continuing to evaluate this issue to determine the need for any regulatory action.Polyethylene glycol oral laxative (various trade names) Neuropsychiatric events FDA is continuing to evaluate this issue to determine the need for any regulatory action.Raltegravir (Isentress) Psychiatric events The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events.Raltegravir (Isentress) labelingSelegiline (Emsam) Hypertension FDA is continuing to evaluate this issue to determine the need for any regulatory action.Sumatriptan/naproxen (Treximet) Myocardial infarction FDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.Testosterone gel (Androgel, Testim) Adverse events from accidental exposure May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.Tolterodine tartrate (Detrol) Stevens-Johnson syndrome FDA is continuing to evaluate this issue to determine the need for any regulatory action.Varenicline (Chantix) Angioedema, serious skin reactions, visual impairment, accidental injury FDA is continuing to evaluate these issues to determine the need for any regulatory action. -- Page Last Updated: 06/04/2009 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm161063.htm Quote Link to comment Share on other sites More sharing options...
Michaelangelica Posted August 3, 2010 Author Report Share Posted August 3, 2010 « Has health reform got you tearing your hair out? Here’s some relief…How can we put all health interventions on an equal footing? A Croakey survey »Pfizer’s billion dollar payout in US prompts calls for action hereSeptember 3, 2009 – 9:10 pm, by Croakey News that Pfizer is paying $2.3 billion in the US to settle a marketing case has prompted a call for changes in the way Australia does business from Dr Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University. He writes: The New York Times report says: “Prosecutors said that they have become so alarmed by the growing criminality in the industry that they have begun increasing fines into the billions of dollars and will soon start charging doctors individually as well.” Not in Australia unfortunately! This topic was aired on ABC Radio “World Today” program today. The transcript hasn’t added my interview but I made the point that Pfizer Australia has had 17 complaints against Medicines Australia self-regulatory Code of Conduct upheld during 2005-09. Although one of these complaints received the maximum fine of $200,000, over this time the fines only averaged $50,000. There is no evidence that such fines have reduced Code violations by Pfizer or other member companies. Somewhat different to the $2.8 billion fine imposed on Pfizer by U.S. regulators!Pfizer’s billion dollar payout in US prompts calls for action here – Croakey Quote Link to comment Share on other sites More sharing options...
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