Non-steroidal anti-inflammatory drugs (NSAIDs) are among the
mostfrequently- prescribed drugs in the Western world. During the past
decade a large number of new compounds were marketed, some of which had
to be withdrawn after a short while because of adverse drug reactions.
These experiences led to an under- standing that a complete picture of
the safety of these drugs can only be obtained after their introduction
into the marketplace. Differentmethods ofpost-marketing surveillance
(PMS) serve as important tools for monitoring the frequency of adverse
reactions and for generating and corroborating hypotheses. Experience
with PMS has thusfar been quite limited in Germany. In 1987 a non-profit
organization, "Verein zur Langzeituntersuchung von Arzneimittel-
wirkungen auf dem Gebiet der Rheumatologie e. V. " (VLAR) was founded by
interested physicians and pharmacologists to raise funds and perform
investiga- tions on the safety of NSAIDs. The first project by the VLAR,
SPALA ("Safety Profile of Antirheumatics in Long-Term Administration"),
was sponsored by F. Hoffmann-La Roche AG (Basel, Switzerland). In July
1990, when the project was successfully terminated, almost 30,000
patients had been completely docu- mented and their medical records
entered into a computer for subsequent review by a select panel of
experts with experience in monitoring adverse reactions to NSAIDs. The
comments, criticisms, and ideas of these experts were brought togetherat
a symposium organized by the VLAR at the Klinikum Steglitz (Berlin,
Germany) on 12 October 1990.