http://www.ama-assn.org/sci-pubs/sci-news/1998/snr0415.htm#jma71005
http://www.ama-assn.org/sci-pubs/sci-news/1998/snr0415.htm#jma71005
Science News Update
News from JAMA and ARCHIVES Journals
Week of April 15, 1998
JAMA
REPORTS
CHILDREN
POISONED BY LAX DRUG MANUFACTURING PRACTICES
Contaminated acetaminophen syrup associated with the deaths of 88 Haitian children
CHICAGO-Poor
quality control measures in the manufacture
of a children's medicine were responsible for its contamination and the
subsequent death of 88 Haitian children, according to an article in the
April 15 issue of The Journal of the American Medical Association (JAMA).
Katherine
L. O'Brien, M.D., M.P.H., from the Centers for
Disease Control and Prevention in Atlanta, Ga., and colleagues investigated
the deaths of 88 children caused by sudden kidney failure that occurred in
Haiti between October 1995 and July 1996.
The
researchers identified were 109 children with acute
renal failure, of whom 88 died. Further investigation found that glycerin
imported to Haiti from China through Europe was used in locally
manufactured acetaminophen syrup and was found to be contaminated with
diethylene glycol (DEG), a toxic chemical with industrial uses including
antifreeze, plasticizer and solvent.
The
researchers believe that between 45 and 75 additional
cases of DEG toxicity were averted by an intervention. Immediately
following the discovery of the source of the toxin, notification went out
through radio, television, newspapers and other sources.
The
researchers write: "This outbreak highlights the
challenges in developing countries where there may not be adequate
regulation, enforcement, or strict implementation of current good
manufacturing practice regulations in the pharmaceutical sector. Not only
should strict quality control procedures be required in all countries where
pharmaceutical products are manufactured, but these procedures must be
consistently and fully applied, otherwise an outbreak such as this could
occur even in countries where quality control procedures are usually
strictly applied."
They
conclude: "It is likely that disasters such as these
will continue to occur until strict quality control procedures are used
consistently by all pharmaceutical manufacturers and until countries around
the world adopt and enforce regulations that ensure the safety of
pharmaceutical products." (JAMA. 1998: 279:1175-1180)
Editorial:
The Haitian Diethylene Glycol Poisoning Tragedy
In
an accompanying editorial, Alan D. Woolf, M.D.,
M.P.H., of Children's Hospital in Boston, Mass., writes: "It is significant
that the outbreak of DEG poisoning reported by O'Brien et al occurred in an
impoverished developing country. In the global accounting of richer
developed vs. poorer developing countries, inadequate regulation and
surveillance of the safety of medications seems an extraordinarily
regressive tax."
Similar
epidemics, in which medication was contaminated
with DEG, have been reported in Argentina, Bangladesh, Spain, Nigeria, and
South Africa. The first reported DEG contamination occurred in the United
States more than 60 years ago when 72 percent solution of DEG was
mistakenly used to dissolve sulfanilamide, resulting in more than 105
deaths. This prompted the U.S. Congress to enact the 1938 Federal Food,
Drug and Cosmetic Act, legislation that thereafter closely regulated the
formulation and safety of medicinal products, according to Dr. Woolf.
Dr.
Woolf concludes: "Improved surveillance and early
detection of DEG in adulterated medications using inexpensive methods
applicable in the field, as suggested by O'Brien et al, may be additional
strategies implemented in a successful global approach. The Haitian
epidemic replays all the past folly involved with DEG contamination. There
are no new public health lessons from the Haitian tragedy." (JAMA. 1998;
279:1215-1216)