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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_386"
                     title="FDA Approves First Excess Finger Collagen Drug"
                     score="0.01"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18277?impressionId=1265772845284"
                     
      &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_359"
                     title="Fish Oil May Prevent Psychotic Episodes (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/18242?impressionId=1265772845284"
                     
      &lt;p&gt;High-risk psychiatric patients were less likely to have psychotic episodes when they took daily doses of omega-3 (&amp;#969;-3) polyunsaturated fatty acids (PUFAs), according to results of a small, randomized clinical trial.&lt;/p&gt;
&lt;p&gt;Fewer than 5% of patients had psychotic episodes with &amp;#969;-3 PUFAs, versus more than 25% of patients given placebo (&lt;em&gt;P&lt;/em&gt;=0.007), investigators reported in the February &lt;em&gt;Archives of General Psychiatry&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The &amp;#969;-3 PUFAs, derived from fish among other sources, also reduced positive, negative, and general symptoms and improved functioning compared with placebo, the researchers found.&lt;/p&gt;
&lt;p&gt;&quot;The present trial strongly suggests that &amp;#969;-3 PUFAs may offer a viable prevention and treatment strategy with minimal associated risk in young people at ultra-high risk of psychosis, which should be further explored,&quot; G. Paul Amminger, MD, of the Medical University of Vienna in Austria, and co-authors concluded.&lt;/p&gt;
&lt;p&gt;Early treatment of schizophrenia and other psychotic conditions may lead to better outcomes, the researchers noted. Subclinical psychotic symptoms may predict psychotic disorder, and the propensity for psychosis in a particular population may influence the prevalence and incidence of psychotic disorders.&lt;/p&gt;
&lt;p&gt;Intervention in at-risk populations, therefore, may lead to even better outcomes, they asserted.&lt;/p&gt;
&lt;p&gt;Dysfunctional fatty acid metabolism has been proposed as a contributing factor in psychotic conditions, and several clinical trials have demonstrated beneficial effects of &amp;#969;-3 PUFA supplementation in patients with schizophrenia. Some studies, however, yielded negative results.&lt;/p&gt;
&lt;p&gt;Data from the schizophrenia studies, evidence of neuroprotective properties, and an absence of clinically relevant adverse effects make &amp;#969;-3 PUFAs &quot;an ideal candidate for indicated prevention in young people at risk of psychosis, in whom the use of antipsychotic medication is controversial, the authors wrote.&lt;/p&gt;
&lt;p&gt;To evaluate potential benefits of &amp;#969;-3 PUFAs in subclinical psychosis, investigators enrolled patients ages 13 to 25 who met criteria for one of three operationally-defined, high-risk groups: attenuated positive psychotic symptoms, transient psychosis, and genetic risk plus a decrease in functioning.&lt;/p&gt;
&lt;p&gt;&quot;These criteria comprise a combination of trait and state factors that identify people whose risk of becoming psychotic may approach 40% within a 12-month period,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;The study included 81 patients, who were randomized to 1.2 g/d &amp;#969;-3 PUFA or matching placebo for 12 weeks, plus 12-months of follow-up.&lt;/p&gt;
&lt;p&gt;The authors reported that 76 patients (38 in each group) completed the 12-week intervention phase and 67 completed the 12-month follow-up. The primary outcome was conversion to a psychotic episode, defined by the Positive and Negative Syndrome Scale (PANSS) and sustained for one week.&lt;/p&gt;
&lt;p&gt;At 12 months, two of 41 patients assigned to &amp;#969;-3 PUFA therapy (4.9%) converted to psychotic episodes, compared with 11 of 40 (27.5%) in the placebo group.&lt;/p&gt;
&lt;p&gt;The &amp;#969;-3 group also had significantly lower PANSS positive, negative, general, and total scores at 12 weeks, six months, and 12 months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;=0.01). Patients in the &amp;#969;-3 group also had significantly better functioning (&lt;em&gt;P&lt;/em&gt;=0.002).&lt;/p&gt;
&lt;p&gt;Calculation of number needed to treat (NNT) showed that four at-risk patients would have to be treated to prevent one psychotic episode during one year, which the authors said is comparable to the NNT from trials of antipsychotic medications.&lt;/p&gt;
&lt;p&gt;The authors noted several limitations, including the relatively small size of the study and the fact that this was a highly selected population, so the results cannot be generalized.&lt;/p&gt;
&lt;p&gt;In addition, they pointed out that efficacy beyond the 12 month study period is unknown and it is possible that the transition to a first episode of psychosis may have been delayed rather than prevented.&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 the Stanley Medical Research Institute.&lt;/p&gt;&lt;p&gt;The authors reported no relevant disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_356"
                     title="Exercise Builds Brain Volume in Schizophrenia (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/18236?impressionId=1265772845284"
                     
      &lt;p&gt;Three months of aerobic exercise significantly increased the volume of the hippocampus in patients with chronic schizophrenia, researchers said.&lt;/p&gt;
&lt;p&gt;The increase was accompanied by &quot;modest&quot; increases in short-term memory and markers of neuron production, according to Frank-Gerald Pajonk, MD, of Dr K. Fontheim&apos;s Hospital for Mental Health in Liebenburg, Germany, and colleagues.&lt;/p&gt;
&lt;p&gt;But it&apos;s too early to say whether incorporating aerobic exercise into treatment programs might reduce the disability associated with schizophrenia, the researchers said in the February&lt;em&gt; Archives of General Psychiatry&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Among schizophrenics, the hippocampus, which plays important roles in memory and spatial navigation, is known to be reduced in volume, Pajonk and colleagues noted.&lt;/p&gt;
&lt;p&gt;Unlike other forms of psychosis, they added in the journal, schizophrenia is characterized by persistent disability, perhaps because the production of new neurons is impaired.&lt;/p&gt;
&lt;p&gt;As well, they noted, in healthy humans it has been shown that exercise stimulates the production of new neurons.&lt;/p&gt;
&lt;p&gt;For those reasons, they speculated that aerobic exercise might increase the volume of the hippocampus in people with chronic schizophrenia, perhaps leading to clinical benefits.&lt;/p&gt;
&lt;p&gt;To test the idea, they enrolled 24 schizophrenia patients and eight healthy controls.&lt;/p&gt;
&lt;p&gt;Thirteen of the patients, selected randomly, were assigned to a three-month program of aerobic exercise  --  cycling three times a week for 30 minutes. The controls also took part in the cycling program.&lt;/p&gt;
&lt;p&gt;The remaining patients were assigned to play table soccer, again for 30 minutes three times a week.&lt;/p&gt;
&lt;p&gt;The primary endpoint was the change in hippocampal volume, assessed by magnetic resonance imaging, but the researchers also looked at changes in schizophrenia symptom scores, memory, and the ratio of N-acetylaspartate to creatine in the hippocampus. The latter is a regarded as a marker of neuron production.&lt;/p&gt;
&lt;p&gt;They found: &lt;ul&gt; &lt;li&gt;Compared to baseline, hippocampal volume increased 12% in the exercise group and 16% in the controls, changes that were significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001.&lt;/li&gt; &lt;li&gt;On the other hand, there was a nonsignificant 1% drop in volume among patients who did not take exercise.&lt;/li&gt; &lt;li&gt;The changes in hippocampal volume in the exercise group were significantly correlated (at r=0.71 and &lt;em&gt;P&lt;/em&gt;=0.003) with better aerobic fitness, as measured by change in maximum oxygen consumption.&lt;/li&gt; &lt;li&gt;Among patients in the exercise group, change in hippocampal volume was associated with a 35% increase in the N-acetylaspartate to creatine ratio, which was significant (in a post-hoc analysis) at &lt;em&gt;P&lt;/em&gt;=0.04. There was no significant change in the healthy controls.&lt;/li&gt; &lt;li&gt;And short-term memory improvements among the patients were correlated (at r=0.51 and &lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) with changes in hippocampal volume.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The change in hippocampal volume was the &quot;most robust&quot; of the findings, Pajonk and colleagues said, and is roughly comparable with what is seen in other subcortical structures when schizophrenia patients switch from typical to atypical medications.&lt;/p&gt;
&lt;p&gt;The study was limited by its small size, they said, and the volunteers were selected for their willingness to take part in three months of an exercise program.&lt;/p&gt;
&lt;p&gt;As well, patients had to have chronic disease and be on stable medication programs, they said.&lt;/p&gt;
&lt;p&gt;They also noted that while the main finding was robust, the statistical significance of the secondary results would not have survived a correction for multiple testing.&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 researchers did not report any industrial support for the study. Pajonk reported financial links with AstraZeneca, Eli Lilly, Janssen, Novartis, Wyeth, Bristol-Myers Squibb, Pfizer, Sanofi-Synth&amp;#233;labo, and Merz.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.008"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265772845284"
                     
      &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="0.008"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265772845284"
                     
      &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>
</recommendedContent>
