<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_432"
                     title="Short Needle May Short HBV Protection for Obese (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18348?impressionId=1265790703632"
                     
      &lt;p&gt;Obese adolescents and young adults may not generate an adequate immune response to hepatitis B (HBV) vaccine because the needles used to vaccinate them are too short, a randomized study suggests.&lt;/p&gt;
&lt;p&gt;Immunization with a 1.5-inch needle was associated with 80% higher anti-HBV titers than a 1.0-inch needle, researchers reported online in &lt;em&gt;Pediatrics.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The difference persisted in analyses performed to correct for imbalances in the study population.&lt;/p&gt;
&lt;p&gt;&quot;This supports the hypothesis that inadequate muscle penetration is responsible, at least in part, for lower immune response to HBV vaccine among obese adolescent and adult vaccine recipients,&quot; Amy Middleman, MD, of Baylor College of Medicine in Houston, and colleagues concluded.&lt;/p&gt;
&lt;p&gt;Several studies have shown that adolescents and adults with a higher body mass index (BMI) have lower antibody titers after HBV vaccination. The observations have taken on new significance, given that an increasing number of vaccines target a population that has a rising BMI, the authors wrote.&lt;/p&gt;
&lt;p&gt;Researchers hypothesize that standard-length needles do not penetrate through the deltoid fat and into the muscle of obese adolescents and adults. Because of its less abundant blood supply, adipose tissue may delay antigen presentation to B and T cells responsible for immune response, the authors continued.&lt;/p&gt;
&lt;p&gt;To test the hypothesis, Middleman and colleagues conducted a randomized, clinical trial involving adolescents and adults ages 14 to 24 with no prior exposure to HBV vaccine. Eligibility criteria included weight &amp;gt;90 kg for female patients and &amp;gt;120 kg for male patients.&lt;/p&gt;
&lt;p&gt;Patients were randomized to receive the HBV vaccine series with a standard one-inch needle or a 1.5-inch needle. Patients younger than 19 received 0.5-mL injections, and older patients received 1.0-mL injections.&lt;/p&gt;
&lt;p&gt;Investigators used a standardized injection procedure: insertion of the needle at a 90&amp;#176; angle to the deltoid muscle, leaving 2 to 3 mm of needle visible between the skin and the hub.&lt;/p&gt;
&lt;p&gt;Patients received three doses of vaccine at baseline, one month, and four months. Blood samples were obtained at baseline and two months after the final injection.&lt;/p&gt;
&lt;p&gt;The two groups did not differ significantly with respect to median age (21), BMI (~40), deltoid skinfold (41 mm), triceps skinfold (~40 mm), days between vaccine doses one and three (~135), and days from third vaccine dose to titer assessment (65).&lt;/p&gt;
&lt;p&gt;At the end of the study, 24 patients had completed the immunization protocol, 10 in the one-inch group and 14 in the 1.5-inch group.&lt;/p&gt;
&lt;p&gt;Patients vaccinated with a one-inch needle had a median antibody titer of 189.8 mIU/mL compared with 345.4 mIU/mL for patients vaccinated with the 1.5-inch needle (&lt;em&gt;P&lt;/em&gt;=0.03).&lt;/p&gt;
&lt;p&gt;The between-group difference remained significant in analyses that excluded an outlier from the 1.5-inch group (&lt;em&gt;P&lt;/em&gt;=0.047) and that excluded the only two male patients in the study (&lt;em&gt;P&lt;/em&gt;=0.035).&lt;/p&gt;
&lt;p&gt;&quot;As we continue to experience high rates of obesity in the U.S. and throughout the world, additional evidence-based research on optimizing the effective delivery of immunizations to adolescents and young adults will be critical,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Following updated needle length recommendations will be a first step toward improving the health of our youth and young adults by preventing vaccine-preventable diseases.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by federal grants and awards. GlaxoSmithKline provided the vaccine.&lt;/p&gt;&lt;p&gt;The authors had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_386"
                     title="FDA Approves First Excess Finger Collagen Drug"
                     score="0.009"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18277?impressionId=1265790703632"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first drug for the progressive hand disease known as Dupuytren&apos;s contracture  --  the injectable collagenase clostridium histolyticum (Xiaflex).&lt;/p&gt;
&lt;p&gt;The biologic drug, manufactured by Auxilium Pharmaceuticals of Malvern, Pa., breaks down excess collagen that builds up in the hand, preventing preventing the fingers from relaxing and straightening normally.&lt;/p&gt;
&lt;p&gt;In announcing the approval, the FDA noted that until now the only effective treatment for the condition was surgery, which often entails a long recovery with physical therapy.&lt;/p&gt;
&lt;p&gt;Drug approval was based on data from two randomized, double-blind, placebo-controlled, multicenter trials of 374 adult patients who had not received surgical treatment on a selected primary joint within 90 days of the first injection, and who did not use anticoagulation medicine within seven days of the study.&lt;/p&gt;
&lt;p&gt;The primary endpoint in both studies was a reduction of joint contracture by five degrees after up to three injections. Patients in the collagenase group outperformed placebo, with 64% meeting endpoint in all joints versus 7% in placebo group in Study 1, and 44% versus 5% in Study 2.&lt;/p&gt;
&lt;p&gt;Serious side effects of the collagenase drug include tendon rupture and ligament damage that can prevent a finger from fully bending and may require surgery to correct.&lt;/p&gt;
&lt;p&gt;Other side effects include swelling, bruising, bleeding, and injection site pain.&lt;/p&gt;
&lt;p&gt;Patients using anticoagulants other than low-dose aspirin should avoid using collagenase clostridium histolyticum, according to the prescribing information.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.007"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265790703632"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has updated labels of the HIV drug didanosine (Videx and Videx EC) to include warnings for potentially serious liver damage.&lt;/p&gt;
&lt;p&gt;Although these cases are rare, the drug may cause noncirrhotic hypertension in patients, a potentially fatal complication which the FDA discovered through 42 postmarket, adverse event reports.&lt;/p&gt;
&lt;p&gt;Of those patients, three required liver transplant and four died. Two deaths were caused by esophageal hemorrhage, while two more were caused by progressive liver failure.&lt;/p&gt;
&lt;p&gt;One patient suffered multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis.&lt;/p&gt;
&lt;p&gt;The FDA said in a statement that it chose not to recall the drug because it believes its benefits outweigh potential risks, but advised that treatment decisions be made on an individual basis between healthcare professionals and patients.&lt;/p&gt;
&lt;p&gt;The agency added that causal association is difficult to determine in postmarket reports, but that alternative causes of the hypertension were ruled out in well-documented cases.&lt;/p&gt;
&lt;p&gt;Healthcare professionals who determine didanosine is effective in treating a patient should monitor that patient for the development of portal hypertension and esophageal varices, the agency said.&lt;/p&gt;
&lt;p&gt;Didanosine is used in combination with other HIV medications to help maintain CD4 cells in patients.&lt;/p&gt;
&lt;p&gt;The drug already has a black box warning for lactic acidosis and hepatomegaly with steatosis.&lt;/p&gt;
&lt;p&gt;Like the antiretroviral agents hydroxyurea and ribavirin, didanosine has been associated with the development of liver toxicity.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.007"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265790703632"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_298"
                     title="FDA Updates Myeloma Drug Label for New Risks"
                     score="0.002"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18158?impressionId=1265790703632"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has revised dosage and safety information for bortezomib (Velcade), the myeloma and mantle cell lymphoma drug, to reflect an increased toxicity risk.&lt;/p&gt;
&lt;p&gt;The new labeling includes a warning for patients with moderate-to-severe hepatic impairment and now recommends at-risk patients start at a lower dosage of 0.7 mg for the first cycle of treatment and escalate to 1.0 mg, or reduce further to 0.5 mg, in subsequent cycles.&lt;/p&gt;
&lt;p&gt;The label has also been updated to include clinical study data showing a higher median survival rate in patients using a combination of bortezomib, melphalan, and prednisone versus a regiment of just melphalan and prednisone (&lt;em&gt;P&lt;/em&gt;=0.00084).&lt;/p&gt;
&lt;p&gt;The drug is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. The FDA also warns that women should avoid becoming pregnant while undergoing treatment with bortezomib.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Millennium: The Takeda Oncology Company of Cambridge, Mass.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>