Drug safety risks

Edwards, M. P., Price, D. A. Role of Physiochemical Properties and Ligand Lipophilicity Efficiency in Addressing Drug Safety Risks. Annu. Rep. Med. Chem. 2010, 45, 381-391. 

Horisberger B, Dinkel R. 1989. The Perception and Management of Drug Safety Risks. Berlin, Germany Springer-Verlag. 

Conaghan PG, Day RO. Risks and benefits of drugs used in the management and prevention of gout. Drug Safety 1994 11 252-258. 

Cavero, I. and Crumb, W. (2005) ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs a critical analysis. Expert Opinion on Drug Safety, 4, 509-530. 

Auhert, M., Osterwalder, R., Wagner, B., Parrilla, I., Cavero, I., Doessegger, L. and Ertel, E.A. (2006) Evaluation of the rahhit Purkinje fibre assay as an in vitro tool for assessing the risk of drug-induced torsades de pointes in humans. Drug Safety, 29, 237-254. 

The FDA s postmarketing surveillance of drug safety in FY 2003 includes a new database on prescribed drug use (with patient idenhhes removed). The agency uses this database of marketed drugs to "make risk assessments and decisions about the most appropriate way to manage any new risk or new perspective on a previously known... 

Impurities in drug substances and drug products continue to be a source of great concern, discussion, debate, and research. " These concerns and debates typically center on the potential safety risks associated with impurities due to contamination and the setting of acceptance criteria. However, the bulk of the work being performed in the pharmaceutical industry, with respect to impurities, is focused on the isolation, identification, qualification and quantification of impurities that are found as a result of the manufacturing process or through chemical decomposition. On the... 

Miller MM, Hayduk R. Benefits and risks of pharmacotherapy for narcolepsy. Drug Safety 2002 25(11) 791-809. 

FDA has also formed a Drug Safety and Risk Management Advisory Committee during this time, provided specific training for the members and has subsequently placed selected members on Advisory Committee Panels to consider various risks or to review existing risk management programs. 

Fundamental distrust of the industry s ethics. The public realisation that research studies have been withheld from public view, or released in partial (and misleading) form, has created enormous pressures for industry to make information on all trials available via the internet. The delays in relabelling products, the precipitous withdrawal of widely marketed drugs and the failure to identify safety risks before approval (even when it was not scientifically possible to do so) gives support to the canard that companies put profits before people. And prosecutions of major companies for... 

DTCA mitigates undertreatment of the condition, but it also appears to encourage marginal and possibly inappropriate treatment. Which of these effects dominates is at this point unclear, but it is reasonable to assume that the direction and size of the net impact varies across therapeutic classes and drugs. There is also some preliminary nonexperimental evidence suggesting that consumers adherence to treatment is affected considerably by perceived safety risks, particularly when emphasized in television advertisements. 

It is clear that pharmacovigilance (the study of clinical drug safety and benefit-to-risk analysis) should have four major goals ... 

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