Introduction - Uppsala Monitoring Centre

1930–1940 median = 26 years (4 drugs) range 5–57 years
1940–1950 median = 28 years (5 drugs) range 19–32 years
1950–1955 median = 17 years (7 drugs) range 3–37 years
1955–1960 median = 20 years (14 drugs) range 3–45 years
A study of withdrawals in the UK and the US, between 1964 and 1983, had a median time of 6 years (24 drugs)
range 1–80 years (Bakke et al., 1984).
A survey of withdrawals in the UK and the US, between 1971 and 1992, had a median time of 4.6 . years (23 drugs)
range 4 months–13 years (Abraham & Davis, 2005).
In the 1970s the average drug lifespan was 12.3 years, which dropped to 6.6 years in the 1980s and dropped
further in the 1990s to 2.6 years (Armer & Morris, 2004).
A study of withdrawals in the UK, US and Spain, between 1974 and 1993, had a median time of 5 years (29 drugs)
range 0–17 years (Bakke et al., 1995).
There is a steady decline in withdrawal times until between 1960 and 1983 when
there is a sudden plateauing at 5/6 years. One of the factors may have been that as
the number of drugs increased the number of alternatives increased allowing the
more easy banning of a doubtful drug.
There are problems with any definition used for lifespan:
1. The early drugs were never ‘approved by a ‘licensing authority’.
2. The ‘approval date’ may not be the date of the clinical introduction.
3. The first ‘mention’ may well predate the clinical introduction by many years.
4. The original use of the drug may not be the use that was a factor for the ADR.
5. ‘The Consolidated List of Products 2008’ does not include all the drugs found in
this survey.
6. Different salts of the same drug having different lifespans, e.g. arsenic c1000
years; arsenate sodium tonic 37 years: salicylates willow c5,400 years; salicin
146 years; Aspirin 73 years.
7. Some drugs have been banned more than once, e.g. mercury and antimony.
8. Taking a lifespan as the time until the first restriction or withdrawal is very
arbitrary as the drug will be continued to be used. Taking the time to final ban
means that if one poor country keeps a drug on the market its lifespan continues.
As one cannot know how many poor countries ban a drug, but are unable to
prevent its continued marketing then we will have a false figure.
Reasons for differing dates for drug withdrawals in different countries
1. Marketing. Pharmaceutical companies rarely market a drug simultaneously
throughout the world, but choose to start either in their own country or in the most
profitable market. Another factor may be the different approaches of the main
licensing authorities. The differences between the US and UK regulatory
authorities in the development of their drug regulations is explored in ‘Science,
Politics and the Pharmaceutical Industry’ by John Abraham, UCL Press and
between the US and Germany in ‘Regulation of the Pharmaceutical Industry’ by