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Antiseptic soaps often no better than...
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Sandeep Singh Dhillon
Antiseptic soaps often no better than plain water, says FDA – MIMS Malaysia
Pharma News
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The Food and Drug Administration in the United States has banned 19 chemicals that are commonly used in antibacterial soaps last week, as they failed to prove their safety and effectiveness at killing germs.

The ban focused on two ingredients – triclosan and triclocarban – that have been debated on regarding its safety for both humans and the environment. Limited research on animals indicates that hormone levels can be interfered with and the development of drug-resistant bacteria is also possible.

“We have no scientific evidence that they are any better than plain soap and water,” said Dr. Janet Woodcock, the Food and Drug Administration’s drug centre director.
Investigating triclosan since 40 years ago
As far back as 40 years ago, the U.S. Congress had already asked the FDA to investigate the benefits of triclosan as well as other antiseptic ingredients. However it only published its findings after the FDA was accused of delaying a decision on the safety of triclosan through a three-year legal battle with an environmental group, the Natural Resources Defense Council (NRDC).

“Consumers have waited a long time for this sensible safeguard,” said Mae Wu, an attorney of the NRDC. Many others have pushed for the publication of the findings, using research from the Centers for Disease Control and Prevention that found traces of triclosan in the urine of three-quarters of Americans tested for various chemicals.
However, the agency emphasises that many chemicals show up in urine without having any effect immediately but might do so in the long run.
Clinical data needed to support potential benefits
In 2013, a rule was proposed for manufacturers to provide the agency with proven additional data on the safety and effectiveness of certain chemicals present in over-the-counter consumer antibacterial washes.

Data should be from clinical studies proving that these products were indeed antibacterial and stood out from non-antibacterial washes in reducing transmission of bacteria. For the 19 chemicals, manufacturers did not manage to provide the necessary data and they have since been banned. In the case of triclosan, no human or animal studies have proven the drug as either safe or effective.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs,” Dr. Woodcock said, adding, “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

Triclosan’s safety has been regularly questioned as most studies that involved laboratory animals showed changes in testosterone, estrogen and thyroid hormones. Researchers worry that if similar effects were in humans, it could interfere with the regulation of hormones and give rise to problems such as the risk of infertility, early puberty and even cancer. Some studies have also shown that the chemical contributes to liver toxicity and thyroid problems.

Apart from that, although the chemicals have been proven to kill some bacteria, experts worry that frequent use would inevitably develop superbugs that cannot be killed by antibiotics or other drugs. Although these risks do not pose an immediate danger, no potential benefits have been shown, said Dr. Theresa Michele, FDA division chief.
The American Cleaning Institute, a cleaning chemical association disputes the FDA statement and claims that “the FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps.” The FDA has no comment to that statement.

Three additional chemicals – benzalkonium chloride, benzethonium chrloride and chloroxylenol – are still present in antibacterial products and have been give one more year to collect data.

This ruling does not apply to hand sanitisers as most use alcohol instead of antibacterial chemicals. However, the FDA is now undertaking a sweeping reevaluation of soaps and washes used by consumers and health professionals.

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