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Federal agency locates bacteria in certain stool softeners


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As we have previously discussed, the federal Food and Drug Administration (FDA) is the entity responsible for maintaining the safety and efficacy of pharmaceutical products and medications in the United States. As part of this mandate, the FDA investigates reports of defective drugs as well as potential contaminates that could be found in medicines sold to consumers.

Last month, there was an outbreak in several states of people testing positive for a type of bacteria called burkholderia cepacia, or B. Cepacia, for short. This bacteria can cause different problems in different people, including respiratory infection and pneumonia. The FDA launched an investigation and managed to trace the source of the infection back to several lots of a medication produced by one manufacturer.

The medication that appears to have been contaminated with the bacteria is a liquid called docusate sodium, which is generally used as a stool softener, and taken orally. According to the FDA, the water supply in the manufacturing plant in question tested positive for the bacteria, which may have been responsible for the contamination.

The FDA, in its informational release, cautions that companies manufacturing drugs need to take care to ensure that their facilities are free of contaminants and that their products are not adulterated with bacteria or other harmful substances. While the federal agency does its job by determining the sources of these problems and levying consequences under its regulations, people who are injured by defective drugs may also need compensation. Those who have been hurt by a problem with their prescription medication or over-the-counter medication may wish to consider consulting an attorney to determine what rights they may have to hold a manufacturer or seller responsible.

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