Ethylene oxide used in baby powder by MNCs can cause allergy, cancer and blood abnormalities in long run

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.