New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Acetaminophen Update January 13, 2011 FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit - The FDA is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. • In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen. PPI’s and Low Serum Magnesium March 2, 2011 FDA Safety Communication: Proton Pump Inhibitor drugs (PPIs) - Low Magnesium Levels Can Be Associated With Long-Term Use • Prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Immunization Update March 24, 2011 Approval Letter – Zostavax for patients age 50-59 years • Compared with placebo, ZOSTAVAX significantly reduced the risk of developing zoster by 69.8% (95% CI [54.1 - 80.6%]) in 22,439 subjects 50 to 59 years of age. Data from the Shingles Prevention Study demonstrated 64% (95% CI 56-71%) efficacy in patients age 60-69 years and 41% (95% CI 28 -52%) efficacy for patients age 70-79 years and. only 18% (95% CI -29 – 48%) efficacy in patients age 80 and above. New Influenza Vaccine • MAY 10, 2011 The FDA has approved the first Fluzone Intradermal vaccine for adults 18 through 64 years old. It will be available for the 2011-12 influenza season. – Sanofi Pasteur's new product has a needle less than a tenth of an inch long, attached to a pre-filled syringe that holds a smaller amount of influenza vaccine than the company' standard flu shots. – patients have said they prefer the shorter, slimmer needles of the Fluzone Intradermal vaccine, but there's no data yet on whether they are less painful – Reactions around the injection site, including redness, swelling and itching, were more common with the new vaccine than with an intramuscular vaccine, company research found. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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