Introduction - Uppsala Monitoring Centre

four times higher risk of being involved in a traffic accident (Bramness et al.,
2007). Carisoprodol was recognised as drug of abuse in 2002 (Bailey &
Briggs, 2002). It is metabolised to meprobamate, which is also addictive. It
causes a withdrawal syndrome (Reeves & Parker, 2003). It could also cause:
extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of
vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion and
disorientation (www.fda.gov/medwatch/safety/2006/jun06.htm).
SED 1972, SED 1976, SED 1984, SED 1988, SED 1992 and SED 1996: no
mention
SED 1988 its toxicity is low.
Withdrawn: the FDA made it a Schedule IV drug in July 2002 and warned of
idiosyncratic and allergic reactions on 6 th June 2006. Norway withdrew the
combination product containing paracetamol, caffeine in 1996 and the
company withdrew the monotherapy in May 2007. Sweden withdrew
carisoprodol in June 2008. Withdrawn by the European Union in November
2007 (Bramness et al., 2008).
Availability: prior to EU edict–Spain, Sweden, Denmark, Norway, Finland,
Czech Republic, Greece, Hungary, Iceland, Italy, Slovak Republic, and UK.
Drug Lifespan: 45 years
Delay in recognition: 12 years
Delay in regulatory action: 5 years
Time span of withdrawals: < one year
Comment: there seems to be a reluctance to withdraw drugs of abuse until they
become a social problem.
1958 Bunamiodyl (Orabilex, Boniodyl)
Introduced in Holland.
Use: cholecystographic contrast medium
ADR: two cases of renal failure (Rene & Mellenkoff, 1959). March 1961 six cases
developed renal dysfunction out of 593 patients (Blythe & Woods, 1961).
Renal tubular necrosis (Malt et al., 1963) One hundred died of renal failure in
the USA (Schreiner, 1966).
SED 1966: number of cases of acute renal failure
Withdrawn: in January 1964 it became a schedule IV drug in many US states.
Withdrawn in Canada 1963 and not approved in Sweden in 1964 ‘ Despite the
occurrence or 28 cases of renal damage following Bunamiodyl and the
withdrawal of the drug by the FDA the evidence is not conclusive that the agent
is more toxic than those previously used.’ (Harrow & Sloane, 1965). Buniamiodyl
was withdrawn worldwide by the manufacturer in 1984.
Availability: Belgium, Netherlands, UK, Germany and Switzerland.
Drug Lifespan: 5 years