Introduction - Uppsala Monitoring Centre

SED1964 1
SED1966 -
SED1968 -
1971 1
SED1972 -
1977 1
1982 1
Part 3. Regulatory responses to
adverse reactions
Regulatory responses to adverse drug reactions
Usually herbs and drugs disappear from the scene quietly as the cost/benefit ratio
is superseded by that of a new drug and the pharmaceutical company realises that
it is no longer commercially viable. Many of the herbs that dominated the
therapeutic market until the 19th century have persisted, aided by outworn
philosophies, whilst some have had active principles that have been extracted and
have joined the standard pharmaceutical armamentarium. It was not until a central
authority took an interest in pharmaceuticals that action was taken on a nationwide
basis to deal with unsafe drugs. Between the initiation of voluntary withdrawal by
the company and the official withdrawal by the regulatory authority there remains
the grey area where the interaction between the two parties results in the
company withdrawing the drug under pressure from the regulatory authority.
The ultimate sanction is the withdrawal of a drug from the market for all
indications, but before this occurs there are several alternative actions that can be
taken:
Warning of adverse effects
Restrictions on dose and dosage forms
Restrictions on indications
Restrictions on prescription
Restrictions on use of ‘inactive’ drug constituents (Bakke et al., 1984).