4 AMINOPYRIDINE;
ALVIMOPAN;
ARFORMOTEROL;
BOTULINUM TOXIN A;
BRILLINTA;
BUPRENORPHINE;
CARBAMAZEPINE;
DEXTROPROPOXYPHENE;
DEXTROPROPOXYPHENE NAPSILATE;
EXTRANEAL;
FENTANYL;
FENTANYL CITRATE;
FINGOLIMOD;
FLUTICASONE PROPIONATE PLUS SALMETEROL;
FORMOTEROL FUMARATE;
FORMOTEROL FUMARATE PLUS MOMETASONE FUROATE;
GLIMEPIRIDE PLUS PIOGLITAZONE;
GLIMEPIRIDE PLUS ROSIGLITAZONE;
HYDROMORPHONE;
INDACATEROL;
LEVOFLOXACIN;
METFORMIN PLUS PIOGLITAZONE;
METFORMIN PLUS ROSIGLITAZONE;
MORPHINE SULFATE PLUS NALTREXONE;
NOVEL ERYTHROPOIESIS STIMULATING PROTEIN;
PARATHYROID HORMONE[1-34];
PIOGLITAZONE;
PRASUGREL;
RECOMBINANT ERYTHROPOIETIN;
ROSIGLITAZONE;
TESTOSTERONE;
TIAGABINE;
TOCILIZUMAB;
UNCLASSIFIED DRUG;
UNINDEXED DRUG;
VANDETANIB;
VARENICLINE;
ARTICLE;
DRUG SAFETY;
DRUG THERAPY;
FOOD AND DRUG ADMINISTRATION;
HEALTH CARE PERSONNEL;
HOSPITAL;
HUMAN;
MEDICAL EDUCATION;
MEDICAL PRACTICE;
MYELODYSPLASTIC SYNDROME;
PHARMACY;
PHYSICIAN;
POLICY;
PRIORITY JOURNAL;
REGISTER;
RISK ASSESSMENT;
STRATEGIC PLANNING;
THROMBOCYTOPENIA;
EDUCATION, MEDICAL, CONTINUING;
HUMANS;
LEGISLATION, DRUG;
PHARMACEUTICAL PREPARATIONS;
PHYSICIAN'S PRACTICE PATTERNS;
PRODUCT SURVEILLANCE, POSTMARKETING;
RISK ASSESSMENT;
RISK MANAGEMENT;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
US Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research US Department of Health and Human Services September [online] [Accessed 2011 May 10]
US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, US Department of Health and Human Services. Guidance for industry: format and content of proposed Risk Evaluation and Mitigation Strategies (REMS), REMS assessments, and proposed REMS modifications: draft guidance. September 2009 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/ Guidances/UCM184128.pdf [Accessed 2011 May 10]
US Department of Health and Human Services, US Food and Drug Administration Last updated Aug 2009 [online] [Accessed 2011 May 10]
US Department of Health and Human Services, US Food and Drug Administration. Adverse Event Reporting System (AERS). Last updated Aug 2009 [online]. Available from URL: http://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm [Accessed 2011 May 10]
US Department ofHealth andHuman Services,US Food and Drug Administration Last updated April 2011 [online] [Accessed 2011 May 10]
US Department ofHealth andHuman Services,US Food and Drug Administration. Potential signals of serious risks/new safety information identified fromthe Adverse EventReporting System (AERS). Last updated April 2011 [online]. Available from URL: http://www.fda.gov/Drugs/GuidanceCom plianceRegulatoryInformation/Surveillance/AdverseDrug Effects/UCM082196 [Accessed 2011 May 10]
Public perceptions of the pharmaceutical industry and drug safety: Implications for the pharmacovigilance professional and the culture of safety
Olsen AK, Whalen MD. Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety. Drug Saf 2009; 32: 805-10
European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use November [online] [Accessed 2011 Nov 15]
European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use. Guideline on risk management systems for medicinal products for human use. November 2005 [online]. Available from URL: http://www.pharmacoepi.org/riskmgmt/emea100505.pdf [Accessed 2011 Nov 15]
US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Last updated May 2011 [online] [Accessed 2011 Nov 15]
US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Approved Risk Evaluation and Mitigation Strategies (REMS). Last updated May 2011 [online]. Available from URL: http://www.fda.gov/ Drugs/DrugSafety/PostmarketDrug SafetyInformationforPatientsandProviders/ ucm111350.htm [Accessed 2011 Nov 15]
US Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research US Department of Health and Human Services February 2011 [online] [Accessed 2011 May 10]
US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, US Department of Health and Human Services. Guidance for industry: medication guides-distribution requirements and inclusion in Risk Evaluation and Mitigation Strategies (REMS): draft guidance. February 2011 [online]. Available from URL: http://www.fda.gov/down loads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf [Accessed 2011 May 10]
Fluoroquinolone-associated tendinopathy: A critical review of the literature
DOI 10.1086/375078
Khaliq Y, Zhanel GG. Fluoroquinolone-associated tendinopathy: a critical review of the literature. Clin Infect Dis 2003; 36: 1404-10 (Pubitemid 36702874)
US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Last updated 2010 Mar 29 [online] [Accessed 2011 May 10]
US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Information for healthcare professionals: fluoroquinolone antimicrobial drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin)]. Last updated 2010 Mar 29 [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPa tientsandProviders/ucm126085.htm [Accessed 2011 May 10]
Kenilworth (NJ): Schering-Plough [online] [Accessed 2011 May 10]
Cipro (ciprofloxacin) [medication guide]. Kenilworth (NJ): Schering-Plough, 2009 [online]. Available from URL: http://www.accessdata.fda. gov/drugsatfda-docs/label/2009/01953 7s69,19847s43,19857s50,20780s27CiproMedG. pdf [Accessed 2011 May 10]
Questions and answers on guidance for industry: Medication guides
US Food and Drug Administration [online] [Accessed 2011 Aug 30]
US Food and Drug Administration. Questions and answers on guidance for industry: medication guides. Distribution requirements and inclusion in Risk Evaluation and Mitigation Strategies (REMS) 2011 [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ucm248459. htm [Accessed 2011 Aug 30]
US Food and Drug Administration [online] [Accessed 2011 Aug 30]
US Food and Drug Administration. Opioid drugs and Risk Evaluation and Mitigation Strategies (REMS) 2011 [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm [Accessed 2011 Aug 30]