PVmap™ of the Week

ProSanos has initiated a program to publicly provide a limited set of PVmaps™ generated from the FDA's Adverse Event database. A different map will be posted each week focusing on a drug and adverse event combination that is a current topic of discussion within the industry. For more information about PVmaps or the PVmap of the Week program, .

Dopamine Agonists and Pathological Gambling (12/31/2006)
This week's map is a dramatic visual representation of the relationship between dopamine agonists and pathological gambling, the subject of a recent report by the MRHA in the UK. Dopamine agonists are typically used for treating Parkinson's disease, and may be used for Restless Leg Syndrome. This is an Event-focused PVmap, where we use the flexibility of PVmaps to reverse the usual paradigm, and ask, "What drugs are most highly associated with a particular adverse event?" rather than the other way around. In this case, the adverse event is the MedDRA term pathological gambling.

The publicly-available data in the map comes from the FDA via its Adverse Event Reporting System (AERS), using data covering the period from 2001 through the first quarter of 2006. In this case, the points on the map represent drugs rather than adverse events. The drugs at the top of the map are most strongly associated with the adverse event pathological gambling.

The predominance of dopamine agonists is obvious, strongly suggesting a class effect, since all but one of the drugs on the map fall in this class. Tolcapone is a COMT inhibitor, and may be an "innocent bystander", producing a signal because of its strong association with levodopa in therapy for Parkinson's disease.

Event-focused PVmaps
This is an Event-focused PVmap, allowing you to visualize which drugs are most highly associated with a particular adverse event (rather than the other way around). In this case, the adverse event is the MedDRA term pathological gambling, and the red dots represent drugs reported in the AERS database to be associated with pathological gambling. On the horizontal axis of this graph is the reporting ratio, which compares the number of times that a drug is reported with the specified adverse event to the number expected due to chance alone. The vertical axis expresses the statistical significance of the finding. Dots above the horizontal blue line and to the right of the vertical blue line represent "significant signals". The drugs with the strongest association to pathological gambling appear at the top and to the right on the PVmap.

Disclaimers

1. Potential risks highlighted by drug safety analysis must be balanced against the clinical benefit attained by the use of a pharmaceutical product in a given clinical situation. Nothing in these analyses is intended to influence the practice of medicine, nor to weigh the benefits of one product over another.
2. Whether the reporting ratio of an adverse event is high enough to influence the decision to use a given product or products can only be determined by a complete analysis of the benefits, risks, and therapeutic alternatives.
3. Use of the publicly available FDA AERS data does not imply endorsement or agreement of the findings by the FDA Center for Drug Evaluation and Research.
4. There are many factors that can influence how the adverse events are reported in the AERS database and may impact the resulting safety signal. These include but are not limited to: publicity and media attention, litigation, length of time drug is on the market, whether the event in question has been previously attributed to the drug, the source of the report, etc.
5. AERS data must often be "cleaned" prior to analysis. This process may include de-duplication, reconciliation of misspelled product names, mapping of adverse events terms, and other manipulations which could introduce bias into the analysis.
6. PVmaps has been evaluated as a safety signal investigation tool for over two years.