The FDA requires reductions in recommended doses of zolpidem; update on the flu; new BP goals for patients with diabetes; selective use of D-Dimer for suspected DVT; new food safety standards. . . here: 5 quick summaries of medical news headlines with links out to original sources.
FDA Requires Makers of Zolpidem to Decrease Recommended Dosage
The FDA has issued a Drug Safety Communication requiring manufacturers of brand name and generic forms of the insomnia drug zolpidem (Ambien) to decrease the recommended dosage. This communication comes in response to reports that levels of the drug left in the blood the morning after use may be enough to impair activities, such as driving. Physicians are urged to caution all patients currently taking these medications about next-morning impairment.
View the full Drug Safety Communication, here.
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Early Flu Season May Be Weakening in Some Areas, but Not Over
The CDC provided an update on the 2012-2013 flu season and vaccine effectiveness to members of the media on Friday, January 11. Members of the CDC said that this year’s flu season did indeed start early, and that they anticipate another 12 weeks or so of increased activity. As of January 11, 24 states and New York City were reporting high levels of flu activity, down from 29 states in the prior week; 16 states were reporting moderate levels, up from 9 states. Overall, 47 states are reporting widespread flu activity. Researchers with the CDC have estimated this year’s vaccine to have an effectiveness of 62%, saying that the vaccine “is far from perfect” but still the best tool available to prevent the flu.
To hear an audio transcript of the update, click here.
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American Diabetes Association Increases Upper Limit of BP Goals in Patients with Diabetes
The American Diabetes Association has issued new guidelines that will recommend changes in blood pressure goals for patients with diabetes. Based on data from several recent meta-analyses, the association is increasing the upper limit from <130 mm Hg to <140 mm Hg. In a statement, Richard Grant, MD, MPH, incoming chair of the Professional Practice Committee at the ADA said that this change in recommendation should in no way “downplay the importance of treating high blood pressure in people with diabetes.”
The new standards were published in the January 2013 issue of Diabetes Care.
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Selective Use of D-Dimer for Suspected DVT Most Efficient
Results of a recently released study indicate that the selective use of D-dimer testing for the diagnosis of deep vein thrombosis based on pretest probability for the condition is safe and more efficient than testing all patients. The study compared patients presenting with symptoms of DVT who were randomly assigned to either uniform testing or selective testing. Selective testing consisted of performing D-dimer testing in patients with low or moderate clinical pretest probability for DVT or venous ultrasonography without D-dimer testing patients at high risk. Selective testing reduced the number of patients who were sent for ultrasonography and decreased the number of patients who required D-dimer testing. Incidence of venous thromboembolism was similar in both groups.
Read the full study here.
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FDA Steps Up with New Food Safety Standards
The FDA is encouraging the public to comment on new proposed food safety rules that would be designed to help prevent foodborne illness. The Food Safety Modernization Act (FSMA) would consist of two measures. The first rule would require all makers of food, foreign or domestic, that will be sold in the United States to develop a plan to prevent their products from causing foodborne illness, and a plan for correcting any problems that may arise. The second rule focuses on farms. The FDA is proposing enforceable safety standards that focus on science-based and risk-based standards for the safe production of fruits and vegetables.
“The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners,” said FDA Commissioner Margaret A. Hamburg, MD, in a press release. “Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules.”
Information about FSMA can be found here.
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