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12:00 AM
Dec 20, 2004
 |  BioCentury  |  Regulation

Europe's Vioxx experience

While the pharmacovigilance system in Europe is different from that the U.S., it is not necessarily better, and the experience with Vioxx rofecoxib is a case in point. European pharmacovigilance experts had a close look at COX-2 inhibitors as they received a continuous flow of adverse drug reaction reports tied to both Vioxx and the COX-2 class as a whole. However, they were never able to conclude whether there was an increased cardiovascular risk associated with Vioxx.

The European pharmacovigilance system is designed to detect side effects that are very rare events, but it is less able to detect signals pointing to an increase in the incidence of common events, such as heart attacks or stroke. There is a historical reason for the imbalance, as the system was designed in the 1960s in response to the experience with thalidomide.

The system relies heavily on spontaneous, voluntary reports from the healthcare community, which report to the drug maker or the authorities. Drug makers are required by law to submit every report about suspected adverse drug reactions (ADRs) to the national regulators, who then evaluate the report and pass the information on to other member states and the EMEA.

But with 25 member states and different approval pathways, the system is quite complex (see "Europe's Pharmacovigilance Maze," A8). The system is further complicated by the fact that the national agencies all have their own pharmacovigilance commissions whose discussions are not open to experts from other countries. Instead, information exchange is highly formalized.

The Vioxx case is a paradigmatic example. Reports on suspected gastrointestinal and cardiologic side effects of Vioxx...

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