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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_392"
                     title="Parents Often Err in Dosing Kids (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Pediatrics/Parenting/tb/18290?impressionId=1265762070756"
                     
      &lt;p&gt;Adults tasked with giving their children liquid medications often gave them too much, especially when the dosing device was a cup instead of a spoon or oral syringe, researchers said.&lt;/p&gt;
&lt;p&gt;Asked to prepare a 5-mL dose for a child, adult caregivers in a study were almost always within 20% of the target when using a 5-mL syringe, according to a report in the February &lt;em&gt;Archives of Pediatric and Adolescent Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;But about 70% of the 302 parents in the trial put more than 6 mL in cups that were packaged with the medication, H. Shonna Yin, MD, of New York University, in New York City, and colleagues reported.&lt;/p&gt;
&lt;p&gt;Cups with etched markings gave the adults nearly as much trouble, the researchers found, but droppers and dosing spoons were more accurate.&lt;/p&gt;
&lt;p&gt;Yin and colleagues also found that dosing errors were nearly twice as common among caregivers who tested poorly for health literacy (adjusted OR 1.7, 95% CI 1.1 to 2.8).&lt;/p&gt;
&lt;p&gt;Given that many liquid medications come with cups, it may be necessary to reconsider how products intended for young children are packaged, the researchers suggested.&lt;/p&gt;
&lt;p&gt;&quot;Redesign of dosing devices as well as instructions for their use, with a focus on standardization and consistency, has the potential to decrease medication errors and improve safety and efficacy,&quot; Yin and colleagues wrote.&lt;/p&gt;
&lt;p&gt;The researchers recruited adults who brought children to a pediatric clinic in New York&apos;s Bellevue Hospital in late 2008. Participants were given each of six dosing instruments in random order and asked to fill it with one teaspoon (5 mL) of acetaminophen suspension.&lt;/p&gt;
&lt;p&gt;Some 95% of participants were the children&apos;s mothers, with the remaining 5% split between fathers and legal guardians. Most were Hispanic, foreign-born, and poor, and 56% spoke Spanish as their first language. Half were not high school graduates.&lt;/p&gt;
&lt;p&gt;The instruments included the cup packaged with Children&apos;s Tylenol Suspension Liquid, which has printed markings on the side; a cup with etched markings bought from a local drugstore; a 5-mL dropper; a 10-mL dosing spoon; a 5-mL syringe; and a 5-mL syringe with bottle adapter.&lt;/p&gt;
&lt;p&gt;Mean doses actually put into the cups were 6.7 mL (SD 1.7) for those with printed markings and 7.0 (SD 3.2) for those with etched markings.&lt;/p&gt;
&lt;p&gt;Although the mean doses were similar with these devices, fewer parents made errors when using the etched cup. Some 50% of doses measured with it were in the range of 4 to 6 mL, compared with only 30.5% of doses put into the cup with printed markings.&lt;/p&gt;
&lt;p&gt;Small errors (20% to 40% more or less than the target) were also less common with the etched cup: 26.6% of doses, versus 43.7% of doses measured with the printed cup. But the rate of large errors was nearly the same with the two cups, at about 25%.&lt;/p&gt;
&lt;p&gt;With the other instruments, mean doses were close to the target, ranging from 4.6 for the oral syringe with bottle adapter to 5.5 for the spoon.&lt;/p&gt;
&lt;p&gt;From 86% to 94% of doses prepared with these devices were within 20% of the 5-mL target. When errors were made, they were usually small and on the low side of the target, Yin and colleagues found.&lt;/p&gt;
&lt;p&gt;Adjusted odds ratios for making large errors, with the oral syringe as reference, were: &lt;ul&gt; &lt;li&gt;Cup with printed markings: 7.3 (95% CI 4.1 to 13.2)&lt;/li&gt; &lt;li&gt;Cup with etched markings: 6.3 (95% CI 3.5 to 11.2)&lt;/li&gt; &lt;li&gt;Dropper: 0.8 (95% CI 0.5 to 1.5)&lt;/li&gt; &lt;li&gt;Dosing spoon: 0.3 (95% CI 0.1 to 0.9)&lt;/li&gt; &lt;li&gt;Oral syringe with bottle adapter: 0.8 (95% CI 0.5 to 1.5)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;But the spoon was more often associated with dosing errors, both small and large, than the syringe, with an adjusted odds ratio of 1.7 (95% CI 1.1 to 2.7).&lt;/p&gt;
&lt;p&gt;Adjustments included caregivers&apos; age, relationship to child, marital status, language, ethnicity, U.S. birth, socioeconomic status, presence of young child, and presence of child with a chronic medical problem.&lt;/p&gt;
&lt;p&gt;Caregivers were given the Newest Vital Sign test to evaluate their health literacy, which turned out to be a factor in dosing errors, the researchers found.&lt;/p&gt;
&lt;p&gt;Scores of 0 or 1 reflected a high likelihood of limited literacy, 2 or 3 was considered &quot;possible limited literacy,&quot; and 4 to 6 was deemed adequate literacy.&lt;/p&gt;
&lt;p&gt;About 40% of participants had scores of 0 or 1 and 38% scored in the range of 2 to 3.&lt;/p&gt;
&lt;p&gt;Both levels of low health literacy predicted dosing errors, and poor literacy was also significantly associated with increased risk of large errors.&lt;/p&gt;
&lt;p&gt;Adjusted odds ratios for any dosing error and large errors associated with poor literacy were 1.7 (&lt;em&gt;P&lt;/em&gt;=0.02) and 2.3 (&lt;em&gt;P&lt;/em&gt;=0.01), respectively.&lt;/p&gt;
&lt;p&gt;Possible limited literacy predicted any dosing error and large errors with adjusted odds ratios of 1.6 (&lt;em&gt;P&lt;/em&gt;=0.04) and 1.9 (&lt;em&gt;P&lt;/em&gt;=0.07), respectively.&lt;/p&gt;
&lt;p&gt;These findings on health literacy and medication errors have important implications for the design of dosing instruments, Yin and colleagues indicated.&lt;/p&gt;
&lt;p&gt;&quot;Provision of instruments designed to place fewer literacy demands on families is one strategy to decrease dosing errors,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;Limitations to the study included its setting in a clinic, which may not reflect parents&apos; performance at home; the largely Hispanic immigrant sample with low socioeconomic status; and the use of a written test to assess health literacy, which does not measure verbal comprehension and other skills that may contribute to health literacy.&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 funded from internal sources. Yin received partial support from the Pfizer Fellowship in Health Literacy/Clear Health Communication.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_163"
                     title="Obama Pushs for Change on Biologics in Healthcare Bill"
                     score="-0.004"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/17996?impressionId=1265762070756"
                     
      &lt;p&gt;WASHINGTON  --  President Obama has signaled his support for renegotiating a provision in the healthcare reform bill to allow generic versions of biologics to hit the market more quickly.&lt;/p&gt;
&lt;p&gt;Both the House and the Senate bills include provisions to establish a pathway that would allow generic companies to have biologics approved. Currently, no such pathway exists. The provisions would offer brand-name biologic companies a 12-year period during which generic companies would be barred from introducing a competing product.&lt;/p&gt;
&lt;p&gt;In a Thursday closed-door question-and-answer session with members of the House, Obama suggested that a shorter exclusivity period might be in order, even though &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; target=&quot;_blank&quot; title=&quot;Biotech&amp;#8200;Industry&amp;#8200;Flexes&amp;#8200;Muscle&amp;#8200;in&amp;#8200;Biologics&amp;#8200;Debate&amp;#8200;on&amp;#8200;the&amp;#8200;Hill&quot;&gt;Senate&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; target=&quot;_blank&quot; title=&quot;Week&amp;#8200;7:&amp;#8200;House&amp;#8200;Panel&amp;#8200;Approves&amp;#8200;Health&amp;#8200;Reform&amp;#8200;Bill&quot;&gt;House&lt;/a&gt; committees voted strongly in support of 12-year exclusivity.&lt;/p&gt;
&lt;p&gt;Members of Congress who have biologic companies in their districts  --  such as Rep. Anna Eshoo (D-Calif.)  --  support the 12-year period, arguing that biologics are so complex that it would take at least that long for generic companies to produce so-called &quot;biosimilars.&quot;&lt;/p&gt;
&lt;p&gt;But some, including Rep. Henry Waxman (D-Calif.), have said the long exclusivity period will harm patients who will have to wait years to see cheaper versions of drugs for diseases like cancer and multiple sclerosis. In addition, some argue that if significantly less expensive biosimilars come to the market earlier, the nation&apos;s drug costs would be reduced.&lt;/p&gt;
&lt;p&gt;The Obama administration has signaled his support for a shorter exclusivity period all along, said &lt;span&gt;&lt;span&gt;Katie Huffar&lt;/span&gt;, a spokesperson for Coalition for a Competitive Pharmaceutical Market (&lt;span&gt;CCPM&lt;/span&gt;), a group comprised of generic drug companies, pharmacies, several insurance companies, and other corporations.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&quot;The administration has been saying they think it&apos;s too much,&quot; she said.&lt;/p&gt;
&lt;p&gt;There don&apos;t appear to be any supporters of the 12-year exclusivity period at the negotiating table as members of the House and the Senate work with the White House to hammer out a final bill. What&apos;s more, Waxman, who is the House&apos;s biggest opponent of the long exclusivity period, has a seat at that table.&lt;/p&gt;
&lt;p&gt;A spokesperson for Waxman declined to discuss details of negotiation process.&lt;/p&gt;
&lt;p&gt;However, the powerful pharmaceutical lobby, PhRMA, supports the longer exclusivity period, and it&apos;s unclear what effect shortening the period would have on the deal that PhRMA struck with the White House earlier in the healthcare reform process. Under that deal, the drug companies agreed to support reform if the White House promised to limit the industry&apos;s losses to $80 billion over 10 years.&lt;/p&gt;
&lt;p&gt;Huffar said her group has been assured that biogenerics were not part of the deal.&lt;/p&gt;
&lt;p&gt;&quot;No one on the government side of that deal shook on 12 years,&quot; she said.&lt;/p&gt;
&lt;p&gt;A spokesperson for PhRMA said the deal hadn&apos;t changed as of Friday, and the group issued a statement reiterating its support for the 12-year period.&lt;/p&gt;
&lt;p&gt;&quot;...At least 12 years of data protection is needed to help recoup the significant development costs for biologic innovators and to fund research on future treatments and cures,&quot; said PhRMA senior vice president Ken Johnson in the statement. &lt;/p&gt;
&lt;p&gt;During Thursday&apos;s Q&amp;amp;A with the president, Eshoo told Obama that Congress had already overwhelmingly backed the 12-year exclusivity period, a source familiar with the exchange told &lt;em&gt;MedPage Today. &lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Indeed, the House Energy and Commerce Committee voted 47 to 11 to add the biologics amendment to the heatlhcare reform bill and the Senate Health, Education, Labor and Pensions Committee approved the amendment 16 to 7.&lt;/p&gt;
&lt;p&gt;Eshoo criticized healthcare reform negotiators&apos; willingness to ditch the 12-year period when other pharmaceutical elements of the reform bill seem to be &quot;sacrosanct,&quot; the source said.&lt;/p&gt;
&lt;p&gt;Obama replied that &quot;nothing is sacrosanct,&quot; according to a House aide.&lt;/p&gt;
&lt;p&gt;In a letter to Speaker of the House Nancy Pelosi (D-Calif.) that is currently gaining signatures, Eshoo writes:&lt;/p&gt;
&lt;p&gt;&quot;While so many issues are still left unresolved in the debate over healthcare in both the House and Senate, this is an issue that has had overwhelming support from both sides. Additionally, it is an issue both Democrats and Republicans have found agreement on. Changing language that is virtually identical for purpose of a final agreement would be unheard of in a traditional conference approach.&quot;&lt;/p&gt;
&lt;p&gt;But healthcare reform is not moving along according to tradition. Congressional leaders decided to &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; target=&quot;_blank&quot; title=&quot;Congress&amp;#8200;Likely&amp;#8200;to&amp;#8200;Combine&amp;#8200;Healthcare&amp;#8200;Bills&amp;#8200;Informally&quot;&gt;informally combine&lt;/a&gt; the Senate and House bills instead of using the traditional conference approach, which would likely result in a Republican filibuster.&lt;/p&gt;
&lt;p&gt;As of now, it appears that no deal on the biosimilar language has been reached.&lt;/p&gt;
&lt;p&gt;Negotiators are still finalizing details of the healthcare reform bill and are expected send it to the Congressional Budget Office (CBO) in the next few days for a cost estimate.&lt;/p&gt;
&lt;p&gt;Congressional leaders have promised that the bill would be posted for 72 hours before any major vote is taken on it.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_153"
                     title="McNeil Expands OTC Drug Recall"
                     score="-0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/17980?impressionId=1265762070756"
                     
      &lt;p&gt;A recall of Tylenol Arthritis Pain Caplet 100-count bottles started in November has been expanded to include about 500 lots of other popular over-the-counter drugs, the FDA announced today.&lt;/p&gt;
&lt;p&gt;Affected are certain lots of various adult and children&apos;s Tylenol products, Motrin IB tablets and caplets, Benadryl Allergy tablets, Rolaids antacid tablets, Simply Sleep mini-caplets, and St. Joseph chewable and safety-coated aspirin, all made by McNeil Consumer Healthcare.&lt;/p&gt;
&lt;p&gt;Not all of the lots have been linked to consumer complaints of &quot;an unusual, moldy, musty, or mildew-like odor,&quot; but they all have the potential to be affected, according to the company.&lt;/p&gt;
&lt;p&gt;Specific lot numbers affected by the recall can be found at a Web page set up to provide information about the &lt;a href=&quot;http://www.mcneilproductrecall.com&quot; mce_href=&quot;http://www.mcneilproductrecall.com&quot; target=&quot;_blank&quot;&gt;McNeil Product Recall&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;The FDA urged McNeil to perform a thorough investigation into the complaints, which eventually resulted in the expanded voluntary recall. By law, the FDA cannot force a company to withdraw products.&lt;/p&gt;
&lt;p&gt;In a small number of cases, the smell resulted in temporary and nonserious reactions, such as nausea, vomiting, stomach pain, and diarrhea, Deborah Autor, director of the office of compliance in FDA&apos;s Center for Drug Evaluation and Research, said on a conference call with reporters.&lt;/p&gt;
&lt;p&gt;Autor scolded McNeil for taking too long to expand their investigation upon learning of the complaints. She said the company became aware of the problem in September 2008 but did not inform the FDA until about a year later. The FDA has sent the company a warning letter.&lt;/p&gt;
&lt;p&gt;&quot;McNeil should have acted faster,&quot; she said. &quot;When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.&quot;&lt;/p&gt;
&lt;p&gt;An investigation by McNeil determined that the smell is caused by a chemical called 2,4,6-tribromoanisole (TBA), which is formed when a chemical used to treat wood pallets breaks down.&lt;/p&gt;
&lt;p&gt;The wood pallets are used to transport and store materials used in packaging drugs.&lt;/p&gt;
&lt;p&gt;Autor said the FDA is looking into whether any other companies used the same pallets.&lt;/p&gt;
&lt;p&gt;McNeil initially recalled five lots of Tylenol Arthritis Pain Caplet 100-count bottles in November, and subsequently expanded the recall in December to all available lots of the product. (See &lt;a href=&quot;http://www.medpagetoday.com/PainManagement/PainManagement/17713&quot; mce_href=&quot;http://www.medpagetoday.com/PainManagement/PainManagement/17713&quot; target=&quot;_blank&quot;&gt;Company Recalls Tylenol for Arthritis&lt;/a&gt;)&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_1037"
                     title="Tumor Data May Block Approval for Diabetes Drug Liraglutide"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Cardiology/Diabetes/tb/13588?impressionId=1265762070756"
                     
       SILVER SPRING, Md., April 2 -- An FDA advisory panel declined to recommend approval for the investigational diabetes drug liraglutide (Victoza), in light of animal studies linking the injection to thyroid cancer. 
                &lt;p&gt; 
                &lt;p&gt;The Endocrinologic and Metabolic Drugs Advisory Committee voted 12-1 that the rodent data could apply to humans. It then split 6-6 (with one member abstaining) on the question of whether the cancer risk should preclude FDA approval.  
                &lt;p&gt; 
                &lt;p&gt;The manufacturer of liraglutide, Novo Nordisk, assured the panel that the C-cell adenomas and carcinomas seen in rats and mice would not occur in humans, but the committee disagreed. 
                &lt;p&gt; 
                &lt;p&gt;&quot;The animal data [were] worrisome,&quot; said panelist Peter Savage, M.D., an endocrinologist at the National Institutes of Health. &quot;We didn&apos;t see enough data in humans.&quot;
                &lt;p&gt; 
                &lt;p&gt;The panel was less concerned, however, about the five cases of papillary thyroid carcinomas -- the most common type of thyroid cancer -- seen in humans in the sponsor&apos;s trials. 
                &lt;p&gt; 
                &lt;p&gt;The panel chalked those cases up to an &quot;ascertainment bias&quot; and voted unanimously that the cases of human thyroid cancers seen in the trials shouldn&apos;t prevent the FDA from approving the drug.
                &lt;p&gt; 
                &lt;p&gt;The committee also narrowly recommended -- by an 8-5 vote -- that the drug&apos;s cardiovascular risks are acceptable.
                &lt;p&gt; 
                &lt;p&gt;An FDA staff review found that cardiovascular events were about the same for liraglutide compared with other diabetes drugs, but slightly more events were seen in the liraglutide group when compared with placebo. Overall event rates were low.
                &lt;p&gt; 
                &lt;p&gt;Liraglutide, an injectable glucagon-like peptide-1 (GLP-1) mimic, is the second diabetes drug to go before a committee since the FDA ramped up its requirements for cardiovascular safety data on such products last June.
                &lt;p&gt; 
                &lt;p&gt;The new standards were issued in the wake of controversy over rosiglitazone (Avandia), which was shown to increase cardiovascular event risks. 
                &lt;p&gt; 
                &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/5701&quot; target=&quot;blank&quot;&gt;Meta-Analysis Links Rosiglitazone (Avandia) to Risk of Myocardial Infarction&lt;/a&gt;)
                &lt;p&gt; 
                &lt;p&gt;The first such drug, saxagliptin (Onglyza), got the committee&apos;s nod yesterday in a 10-2 vote that its safety appeared acceptable.
                &lt;p&gt; 
                &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/13555&quot; target=&quot;blank&quot;&gt;Saxagliptin First Diabetes Drug to Pass FDA Cardiovascular Safety Review&lt;/a&gt;)
                &lt;p&gt; 
                &lt;p&gt;There is already an FDA-approved GLP-1 mimic, exenatide (Byetta). However, exenatide is administered twice daily, whereas liraglutide would be given once daily.
                &lt;p&gt; 
                &lt;p&gt;&quot;Once a day beats twice a day, hands down,&quot; said the panel&apos;s patient representative Rebecca Killian, from Bowie, Md.
                &lt;p&gt; 
                &lt;p&gt;A once-weekly formulation of exenatide is in development.
                &lt;p&gt; 
                &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/EASD/10830&quot; target=&quot;blank&quot;&gt;Once-Weekly Exenatide Equals Drug at Standard Dose&lt;/a&gt;)
                &lt;p&gt; 
                &lt;p&gt;Exenatide, which is very similar to liraglutide, has not been shown to increase cancer in human populations, said Mary Parks, M.D., an endocrinologist with the FDA. 
                &lt;p&gt; 
                &lt;p&gt;Liraglutide is also unique because it does not cause hypoglycemia or weight gain, said panel member Kathleen Wyne, M.D., Ph.D., an endocrinologist from Methodist Hospital Research Institute in Houston. Those are &quot;the two biggest concerns&quot; for type 2 diabetes patients, she said. 
                &lt;p&gt; 
                &lt;p&gt;An FDA analysis suggested the drug might actually contribute to weight loss.
                &lt;p&gt; 
                &lt;p&gt;The ultimate decision on approval is up to the FDA, which does not have to follow the advice of its advisory panels, but usually does. 
                &lt;p&gt; 
                &lt;p&gt;According to Dr. Parks, the agency seldom approves drugs that caused cancer in two different animals across both genders. 
                &lt;p&gt; 
                &lt;p&gt;&quot;A lot of drugs that have multicarcinogenicity are dropped during development,&quot; Dr. Parks said. &quot;It&apos;s very rare for them to be approved when they are multicarcinogenic and multigender.&quot;
    </recommendedItem>
    <recommendedItem id="20090101_19_1056"
                     title="FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/13619?impressionId=1265762070756"
                     
       WASHINGTON, April 6 -- Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review. 
              &lt;p&gt; 
              &lt;p&gt;The agency released its review in advance of Tuesday&apos;s meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug&apos;s cardiovascular risk is an obstacle to FDA approval. 
              &lt;p&gt; 
              &lt;p&gt;The advisory panel will also consider the sponsor&apos;s suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
              &lt;p&gt; 
              &lt;p&gt;Sertindole is already used in other countries to treat schizophrenia. 
              &lt;p&gt; 
              &lt;p&gt;According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug&apos;s potential to prolong the heart&apos;s QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole. 
              &lt;p&gt; 
              &lt;p&gt;Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta. 
              &lt;p&gt; 
              &lt;p&gt;A recent study found that atypical antipsychotics carry a risk of sudden cardiac death similar to that associated with older schizophrenia drugs.  (See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/12453&quot; target=&quot;blank&quot;&gt;Risk of Sudden Death No Less Likely with Atypical Antipsychotics&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;Sertindole has been approved in the U.K. since 1996. But use of the drug was temporarily suspended after an online database indicated that sertindole might cause more deaths than risperidone (Risperdal). The drug&apos;s manufacturer, Lundbeck, agreed to perform a large randomized parallel-group study comparing all-cause death, cardiac death, and suicide for sertindole versus risperidone.
              &lt;p&gt; 
              &lt;p&gt;Based on results from that nearly 10,000-patient study, which did not show an increase in all-cause mortality with sertindole, the restrictions on the drug were lifted. 
              &lt;p&gt; 
              &lt;p&gt;But in Lundbeck&apos;s analyses to prepare for U.S. approval, the FDA reviewers didn&apos;t think the comparable all-cause mortality data was exactly a home run for sertindole, &quot;given the relatively higher mortality in this population from multiple causes,&quot; Dr. Kronstein said. 
              &lt;p&gt; 
              &lt;p&gt;More relevant are the cardiac deaths, in light of sertindole&apos;s connection to heart problems, he said. The FDA review found that patients taking sertindole had a significantly higher risk of cardiac death compared with those taking risperidone (&lt;em&gt;P&lt;/em&gt;=0.002). 
              &lt;p&gt; 
              &lt;p&gt;Thirteen patients died suddenly from cardiac causes in the sertindole group, compared with three who were taking risperidone. 
              &lt;p&gt; 
              &lt;p&gt;&quot;This is a significant and concerning result, indicating that sertindole-treated patients had an approximately five times higher risk of sudden cardiac death,&quot; according to the review.
              &lt;p&gt; 
              &lt;p&gt;The other major question for the committee is whether Lundbeck can justifiably claim that sertindole prevents suicidality better than other antipsychotic drugs.
              &lt;p&gt; 
              &lt;p&gt;Lundbeck has proposed to include such a claim in the product&apos;s label. In the company&apos;s trials, there were 14 suicide deaths among sertindole patients and 21 in the risperidone group.
              &lt;p&gt; 
              &lt;p&gt;But the FDA&apos;s staff review disagreed with the way Lundbeck examined suicide risk, and requested that the company analyze all suicide attempts instead of only those that succeeded.
              &lt;p&gt; 
              &lt;p&gt;According to the briefing documents for the meeting, this second analysis found that 46 patients attempted suicide during treatment and up to 30 days after in the sertindole group, compared with 62 in the risperidone group, with the difference failing to reach statistical significance.
              &lt;p&gt; 
              &lt;p&gt;The panel is to vote on whether the data show that sertindole reduces suicidality in schizophrenic patients.
              &lt;p&gt; 
              &lt;p&gt;As for the drug&apos;s efficacy in schizophrenia symptoms, two clinical trials have adequately proved the short-term antipsychotic efficacy of between 12 mg and 20 mg daily doses of sertindole, according to the FDA&apos;s Dr. Kronstein. 
              &lt;p&gt; 
              &lt;p&gt;There are no adequate and well-controlled data to address long-term efficacy, he said. 
              &lt;p&gt; 
              &lt;p&gt;The FDA does not have to follow the advice of the panels, but it usually does.
    </recommendedItem>
</recommendedContent>