Multinationals
should stop treating Indians as guinea pigs, the FDA told the Bombay HC on
Friday, while opposing Johnson & Johnson's plea to restart its Mulund
facility as reported in TOI. A division bench of Justice S J Vazifdar and
Justice M S Sonak, the court heard J&J's plea challenging FDA's order
directing closure from June 24.
In
2007, J&J had used ethylene oxide (EtO) treatment for 15 batches of baby
powder and did not check for residue. But J&J argued that it had checked
three of the batches for residue in 2009, and had found none.
To
check for contamination, instead of the steam sterilization treatment, they
sent the bottles for EtO treatment to a lab.
After
the treatment, they were no checks for residue. As per FDA, the company was
required to test each batch they put into the market.
About EtO
·
Hypotension,
dyspnea, and chest pain may be produced by sensitivity to the ethylene oxide
used as a membrane sterilant [1].
·
Chemicals
that have been associated with sporadic spontaneous pregnancy loss include
anesthetic gases (nitrous oxide), arsenic, aniline dyes, benzene, ethylene
oxide, formaldehyde, pesticides, lead, mercury and cadmium [2].
·
A
variety of other medications and agents have been implicated in anaphylaxis or
reactions resembling anaphylaxis in susceptible individuals: The sterilization
agents EtO and ortho-phthalaldehyde [3]
·
Type
A allergic reactions during dialysis are caused by leachable substances from
the dialyzer or by contamination with bacterial peptides. A classic cause of
this type of reaction is ethylene oxide, which is used to sterilize hollow
fiber dialyzers. Reactions to ethylene oxide, which are now uncommon, occur
exclusively during the first use, usually when there has been inadequate
rinsing of the dialyzer prior to use. IgE antibodies directed against ethylene
oxide are present in some cases, particularly those with more severe reactions.
One study, found that 16 of 106 unselected patients developed mild allergic
symptoms after hemodialysis; 10 of these patients also developed eosinophilia
[4]. Two observations suggested an important role for ethylene oxide in this
response: allergy to ethylene oxide could be demonstrated in seven of the
cases; and the symptoms and eosinophilia were ameliorated in three patients by
ethylene oxide-free hemodialysis.
·
Spina
bifida patients have been reported to be at increased risk of anaphylactic
reactions during general anaesthesia. Following a reaction, latex is often
incriminated as spina bifida patients are known to have an increased incidence
of latex allergy. Ethylene oxide (EO) has recently been suggested to be an
alternative cause. EtO is a highly reactive gas widely used to sterilise
heat-sensitive medical devices, and traces of EtO can be found in many of the
same products as latex. [5]
·
There
is a link between low dose EtO exposure and breast cancer. [6]
·
For
breast cancer the substances classified as "carcinogenic to humans"
(Group 1) include EtO. [7]
·
Chronic
exposure to EtO causes elevation in the absolute mean number of monocytes and
eosinophils and a decrease in the absolute mean number of lymphocytes. There is
also an elevation in the percentage of hematocrit and the mean absolute number
of the red blood cells, and a decrease in the mean absolute number of
platelets, in the exposed group compared with the control group. [8]
References
1.
Nicholls
AJ, Platts MM. Anaphylactoid reactions due to haemodialysis, haemofiltration,
or membrane plasma separation. Br Med J (Clin Res Ed) 1982;285:1607.
2.
Savitz DA, Sonnenfeld NL,
Olshan AF. Review
of epidemiologic studies of paternal occupational exposure and spontaneous
abortion. Am J Ind Med 1994;25:361.
3.
Ebo
DG, Bosmans JL, Couttenye MM, Stevens WJ. Haemodialysis-associated anaphylactic
and anaphylactoid reactions. Allergy 2006;61:211.
4.
Röckel A, Klinke B, Hertel
J, et al. Allergy
to dialysis materials. Nephrol Dial Transplant 1989;4:646.
5.
Anaphylaxis
to ethylene oxide - a rare and overlooked phenomenon: Bache S, Petersen JT,
Garvey LH. Acta Anaesthesiol Scand 2011;55(10):1279-82.
6.
Mikoczy
Z, Tinnerberg H, Björk J, Albin M. Cancer incidence and mortality in Swedish
sterilant workers exposed to ethylene oxide: updated cohort study findings
1972-2006. Int J Environ Res Public Health 2011;8(6):2009-19.
7.
Weiderpass
E, Meo M, Vainio H. Risk factors for breast cancer, including occupational
exposures. Saf Health Work 2011;2(1):1-8.
8.
Shaham J, Levi Z, Gurvich
R, et al. Hematological
changes in hospital workers due to chronic exposure to low levels of ethylene
oxide. J Occup Environ Med 2000;42(8):843-50.