December 23, 2009

FDA Bill Seeks to Safeguard Against Food Borne Illness

As consumers, we assume that the products we use are safe. This is never more applicable than in our consumption of food. According to a nj.com article, a long-awaited bill proposed by the Senate to overhaul the food safety system set forth by the Food and Drug Administration has been unanimously approved. However, it still needs to go for a floor vote, which is speculated to not take place until sometime in 2010. The bill will allow the FDA to recall tainted food rather than simply make a request to the manufacturer of the food to do so, and will also require food manufacturing plants, especially high-risk facilities, to be regularly inspected.

Currently, the FDA is responsible for safeguarding nearly 80% of the food supply in the U.S. However, safeguarding against food-borne illness does not always prevent the public from falling ill due to tainted food. Currently, it is estimated that nearly 76 million Americans are affected each year by food-borne pathogens. According to the Centers for Disease Control, 5,000 people die annually due to such illness.

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December 21, 2009

Slim-Fast Consumers Beware: Possible Bacillus Contamination Poses Risk

Unilever, the maker of the popular weight loss drink Slim-Fast, has recalled 10 million cans of its canned diet drinks because they may be tainted by bacterial contamination. According to a yahoo.com report, Unilever believes that the dietary aid may be tainted by Bacillus cereus, a bacteria that can cause nausea, vomiting, and diarrhea. The recall only affects ready-to-drink Slim-Fast products, and not the brand’s powdered shakes or snack bars.

The Food and Drug Administration (FDA) became aware of the problem and notified Unilever of the possible contamination on December 2, 2009. The FDA is currently investigating the matter, paying particular attention to a production facility in Covington, Tennessee. Customers who have in their possession such canned drinks should immediately discard those drinks and may contact Unilever at 1-800-896-9479 for a full refund.

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December 8, 2009

FDA Initiates Study of Lasik Eye Surgery's Negative Effects

The Food and Drug Administration has declared its plans to begin a study of the negative side effects following Lasik eye surgery, which include dry eyes, blurred/double vision, and halos around objects at night. According to a recent report, the FDA will coordinate with the Department of Defense and the National Eye Institute to establish the percentage of patients who have been negatively affected by the eye-correcting procedure.

Although it is encouraging that such action is finally being initiated, a clinical trial tracking of patients who undergo the surgery will not conclude until 2012. To start things off, an online questionnaire will help patients gauge their quality of life after Lasik surgery. The head of the FDA’s medical device division stated, “This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects.”

Considering that approximately 6 million Americans have had Lasik surgery, an extremely sensitive procedure that everlastingly reshapes the cornea (a clear layer covering the eye), it is of the utmost importance that the FDA administers this study. Although 95% of Lasik patients are apparently satisfied with the results of their surgery, last summer the FDA received 140 reports of Lasik-related problems of eye damage between 1998 and 2006.

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November 27, 2009

FDA Launches "Safe Use Initiative" to Lower Drug Dosage Errors

In what many people are referring to as “long overdue”, the FDA has recently announced its new program called “The Safe Use Initiative” to help lower wide-ranging problems associated with drug dose errors. According to a latimes.com report, the problem of drug dosage error takes a staggering toll on consumer and patient health in addition to costing about $4 billion a year. In fact, based on a study by the Institute of Medicine in 2007, approximately 1.5 million preventable “adverse drug events” take place in the United States every year. With this information in mind, it is no wonder that the Food and Drug Administration is calling on doctors, consumers, and various other healthcare professionals to help in identifying drugs and circumstances that may be particular problems.

In its efforts to lower the deaths and severe health problems brought about by misuses of medication, the FDA adverse event reporting system and the organization as a whole are trying to determine the most serious threats, dangers, and risks, and find ways to prevent them from happening. The agency is supposed to hold public hearings to gather information pertaining to the following drug concerns:

  • Overuse of acetaminophen (a pain reliever that can cause liver damage if too much is taken)

  • Information given to patients (i.e. package inserts, labels and instructions that pharmacists distribute when giving prescriptions)

  • Ways to lower dosage errors in liquid medications by including a spoon or cup to accurately regulate a dosage

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