Abstract
In 2002 there was upheaval in the Dutch media about the safety of SSRI's. In 1979 a similar media affair arose over the alleged dangerous side effects of the tranquillizer Halcion (triazolam). In both cases the therapeutic drug became associated with serious adverse effects through medical whistleblowers and in response the pharmaceutical profession took up a defensive position. The decision by the Dutch government to suspend Halcion from the market was initially met with fierce criticism from US and UK drug regulatory authorities. Ten years later the very same suspension was granted pioneer status. The Halcion case shows the importance of a pro-active policy by international pharmacy societies in response to social commotion about the safety and effectiveness of therapeutic drugs. This does not guarantee success in restraining the media-driven unrest but at least promotes the credibility of pharmaceutical care. Within this context sympathetic empiricism and experienced-based knowledge may serve as a basis for adverse drug events monitoring. Of course each case-by-case finding should be submitted to sound evidence-based inspection. For this purpose an independent international network of pharmacovigilance is a necessary requirement.
| Translated title of the contribution | History presents lessons for pharmaceutical care. Halcion: The fate of the 'Dutch hysteria' |
|---|---|
| Original language | Dutch |
| Pages (from-to) | 1600-1605 |
| Number of pages | 6 |
| Journal | Pharmaceutisch Weekblad |
| Volume | 138 |
| Issue number | 46 |
| Publication status | Published - 14 Nov 2003 |
Keywords
- serotonin uptake inhibitor
- tranquilizer
- triazolam
- aggressiveness
- amnesia
- article
- decision making
- drug efficacy
- drug industry
- drug marketing
- drug safety
- drug surveillance program
- drug utilization
- evidence based medicine
- government
- hallucination
- history of medicine
- human
- hysteria
- international cooperation
- malaise
- mass medium
- mental health care
- Netherlands
- organization
- patient care
- policy
- side effect
- social aspect
- suicidal behavior