Introduction - Uppsala Monitoring Centre

1935 First use of prontosil red (sulfamidochrysoidine), the first
commercially available antibacterial with a relatively broad effect.
Discovered in 1932 by Bayer chemists, Josef Klarer and Fritz
Mietzsch (Turk 1994). Prontosil is metabolized to sulfanilimide (paraaminobenzenrlsulfonamide),
a much simpler, colourless molecule,
redefining Prontosil as a prodrug (Loudon, 2008).
April 1935. dinitrophenol caused an epidemic of sclerosing cataracts
leading to blindness. September. Forced off the market by the FDA
in 1935 (Hecht 1987). (see under regulatory responses).
Cortisone and ergometrine isolated.
1935 Carlo Levi qualified as a doctor in Italy in 1923 but gave up medicine in
1927 to write and paint. He also became involved in anti-fascist politics.
In 1935 he was sent into internal exile in ‘the God-forsaken country’ of
Lucania in the foot of Italy. Here he witnessed the extreme poverty of
the peasants who, unable to pay the few incompetent doctors or the
unqualified pharmacists for anti-malarial treatment ‘quinine’ to protect
themselves from the endemic disease, died or were crippled by illhealth.
They turned to the local witches for incantations and potions.
One of their favourite magic amulets carried the word
ABRACADABRA. Their poverty protected them from adverse drug
reactions. There must have been many similar situations in the
developed world at that time and, of course, it must have been normal
in the underdeveloped world (Levi, 1945).
1937 September – Elixir Sulfanilamide containing 72% diethylene glycol
(DEG) given to 353 patients during the period of a week. On 2nd
October 1937 a JAMA editorial warned against its use because of
the increasing number of ADRs including dermatitis, photosensitivity,
granulocytopenia and haemolytic anaemia (JAMA Editorial, 1937).
Days later six patients died from renal failure. There were 105 deaths
including 34 children due to renal failure caused by the diethylene
glycol (DEG) (Geiling and Cannon 1938; Wax, 1995). In 1969, in
South Africa, 7 children died of renal failure (vacuolar nephropathy)
due to DEG. In 1986 there were 14 deaths in Bombay. In 1990 47
children died similarly in Nigeria (Wax 1995). In 1995 there were 51
deaths due to DEG (Hamif et al., 1995). In Haiti 88 children died as a
result of paracetamol syrup being contaminated with 14.4% DEG
(O’Brien et al., 1998). In 1998 a cough syrup containing DEG
implicated in 33 deaths in India (WHO Bulletin 2001). In 2006 in
Panama an expectorant contained 8%v/v DEG; 213 died. And so it
goes on.