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Defective drugs: FDA wants info on hand sanitizers


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Residents of Texas are often advised to wash their hands, such as before eating, or after using the restroom or touching publicly used objects. Medical professionals have said that cleaning bacteria off of hands is a major step in preventing transmission of illness. In fact, this advice has become so ubiquitous in American society that a whole industry has sprung up catering to those who wish to protect themselves from bacteria even when soap and water aren’t readily available.

These hand sanitizers, also known more formally as ‘antiseptic rubs,’ are generally sold without a prescription and are used by many people, often several times a day. Unlike soap, which is usually washed off immediately after use, these products are meant to remain on a person’s skin for lengthy periods of time. Now, the federal Food and Drug Administration has announced that they are seeking more comprehensive scientific data from manufacturers of these products regarding their safety and efficacy.

The FDA is especially interested in scientific data on three main active ingredients in hand sanitizers — isopropyl alcohol, ethanol and benzalkonium chloride. While the rule proposed by the agency does not mean manufacturers need to take products off the market, it would require those who wish to continue producing them to provide the government with data on safety and efficacy of these ingredients, as well as information regarding absorption through the skin. Because some scientific data have indicated that people’s systems are exposed to these chemicals more than previously expected, the FDA is interested in information on the effects of repeated, daily exposure on human beings, especially children and women who are pregnant.

This proposed rule highlights the fact that commercial production and use of certain drugs often outpaces the scientific evidence available about their safety, as well as the fact that not all potentially harmful substances come from prescription medications. It is certainly possible, and possibly more likely, due to less regulation, that over-the-counter drugs are sold that are defective or potentially harmful. Anyone in Texas who believes the person is the victim of defective drugs or a negligent manufacturer, may wish to consider contacting an experienced personal injury attorney.

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