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FDA Panel Says No to Over-the-Counter Allergy Drug Singulair

Posted 6 May 2014 by Drugs.com

FRIDAY, May 2, 2014 – A panel of expert advisors to the U.S. Food and Drug Administration on Friday voted overwhelmingly against moving the allergy drug Singulair from prescription to over-the-counter status. The panel voted 11-to-4 against the sale of the popular medication without a doctor's approval, the Associated Press reported. According to the AP, many on the FDA panel felt there were still questions over the safety of making Singulair available without a prescription, especially because some patients would be using it for "off-label" treatment of conditions such as asthma. The FDA does not have to follow the advice of its expert panels, but it usually does. Two experts in the care of respiratory illness were happy with the panel's vote. "My discomfort about Singulair being sold over the counter mirrors the FDA's concern that it may be used inappropriately for the treatment of ... Read more

Related support groups: Allergies, Singulair, Montelukast

First Generic Versions of Singulair Approved

Posted 7 Aug 2012 by Drugs.com

FRIDAY, Aug. 3 – The first generic versions of Singulair (montelukast sodium) have been approved by the U.S. Food and Drug Administration. The product is not meant to treat sudden onset of serious asthma symptoms, the FDA warned, but it does treat asthma and hay fever symptoms by blocking substances in the body called leukotrienes, the agency said Friday in a news release. The FDA said the product could cause serious side effects, including behavioral or mood changes, depression, hallucinations, upper respiratory infection, or feeling numbness in the extremities. Anyone who has these symptoms should immediately see a physician, the agency said. Less serious but more common adverse reactions could include: fever, headache, sore throat, cough, stomach pain, diarrhea, ear ache or runny nose. Approval to produce generic tablets, generic chewable tablets or both versions was granted to: ... Read more

Related support groups: Asthma, Singulair, Montelukast

High Out-of-Pocket Costs for Kids' Asthma Drugs Could Pose Dangers

Posted 27 Mar 2012 by Drugs.com

TUESDAY, March 27 – When health insurers require parents to pay a larger share of the cost of asthma medications for their children, more kids need emergency asthma treatment, suggests new research. For children older than 5, higher out-of-pocket costs results in a small reduction in medication use and greater rates of hospitalization for asthma complications, the study found. "Asthma is the most common chronic disease in children. We looked at adherence to asthma medications that are intended to be taken year-round to prevent exacerbations [flare-ups]," said one of the study's authors, Dr. Anupam Jena, a physician at Massachusetts General Hospital and Harvard Medical School and a senior fellow at the Schaeffer Center for Health Policy and Economics at the University of Southern California. Jena said that adherence rates for these medications – the rate at which patients stick to ... Read more

Related support groups: Asthma, Singulair, Albuterol, Asthma - Maintenance, Fluticasone, Ventolin, Asthma - Acute, Flovent, Montelukast, ProAir HFA, Mometasone, Proventil, Asmanex Twisthaler, Ventolin HFA, Proventil HFA, Flovent HFA, Flovent Diskus, Volmax, Airet, Respirol

More Children Using Preventive Asthma Drugs: Study

Posted 5 Dec 2011 by Drugs.com

MONDAY, Dec. 5 – About one in three children with asthma is currently using a preventive medication, according to new research. That number is up from about 18 percent of kids during the late 1980s. Preventive asthma medications help control the airway disease before symptoms flare up, and guidelines from the U.S. National Asthma Education and Prevention Program recommend their use. "The main finding from our study was that over 20 years, the use of medicines to prevent asthma has increased among children with asthma," said the study's lead author, Dr. Brian Kit, a medical epidemiologist at the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics. Commenting on the study, Dr. Shean Aujla, a pediatric pulmonologist at the Children's Hospital of Pittsburgh, said, "I think it's encouraging that there's been an increase in the use of preventive ... Read more

Related support groups: Asthma, Singulair, Asthma - Maintenance, Fluticasone, Flovent, Montelukast, Theophylline, Budesonide, Entocort, Entocort EC, Salmeterol, Pulmicort Flexhaler, Formoterol, Foradil Aerolizer, Pulmicort Turbuhaler, Pulmicort Respules, Cromolyn, Gastrocrom, Theochron, Uniphyl

Use of Asthma Controller Meds on the Rise Among U.S. Kids

Posted 13 Oct 2011 by Drugs.com

THURSDAY, Oct. 13 – The percentage of children with asthma in the United States who use a prescription "controller" medicine has nearly doubled since the late 1990s, a new federal government report finds. The analysis of data from the Medical Expenditure Panel Survey showed that the use of controller drugs by these children increased from 29 percent in 1997-1998 to 58 percent in 2007-2008, according to the latest News and Numbers from the U.S. Agency for Healthcare Research and Quality. Asthma controller drugs include: corticosteroids, which control inflammation and reduce the risk of airway spasms; beta-2-agonists, which make breathing easier; and leukotrienes, which help prevent asthma symptoms from occurring. Use of inhaled corticosteroids among American children with asthma increased from 15.5 percent to 40 percent, use of leukotrienes rose from 3 percent to 34 percent, and use of ... Read more

Related support groups: Asthma, Singulair, Albuterol, Asthma - Maintenance, Triamcinolone, Fluticasone, Ventolin, Epinephrine, Qvar, Flovent, Montelukast, Xopenex, Budesonide, Entocort, ProAir HFA, Mometasone, Proventil, Entocort EC, EpiPen, Salmeterol

FDA Approves Redesigned Labels for Some Merck Drugs

Posted 13 Jun 2011 by Drugs.com

    Changes developed under Merck's Label Standardization Project SILVER SPRING, Md., June 10, 2011 /PRNewswire-USNewswire/ – The U.S. Food and Drug Administration today is announcing the approval of Merck's redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Merck's Label Standardization Project includes the revision of 34 container labels for 16 solid oral drug products regulated by the FDA's Center for Drug Evaluation and Research (CDER). Drugs affected by the revisions include: Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinzide, Propecia, Proscar, Singulair, Zocor, and Zolinza. "We commend Merck for their efforts," said Janet Woodcock, M.D., director of CDER. "This was n ... Read more

Related support groups: Singulair, Januvia, Cozaar, Zocor, Janumet, Hyzaar, Proscar, Propecia, Prinivil, Prinzide, Isentress, Noroxin, Mevacor, Zolinza, Crixivan

Asthma Pills Work as Well as Inhaled Steroids: Study

Posted 4 May 2011 by Drugs.com

WEDNESDAY, May 4 – In a study that compared asthma pills against commonly prescribed inhaled steroids, British researchers found that the oral medications were as effective as the inhaled drugs. The oral medications, known as leukotriene-receptor antagonists, "have shown similar efficacy and cost and better compliance, and should be considered for any patient, not as a last option but as an option for any patient," said study co-author Dr. Stanley Musgrove, a senior research associate at the University of East Anglia in Norwich. "Every different patient will have their own issues that are important to their care: their compliance to different medications, how well they feel that different medications work for them, their concerns about different medications, any possible minor side effects, etcetera, and all of those should be considered when the clinician and the patient are making a ... Read more

Related support groups: Asthma, Singulair, Triamcinolone, Fluticasone, Qvar, Flovent, Montelukast, Budesonide, Entocort, Mometasone, Entocort EC, Beclomethasone, Asmanex Twisthaler, Pulmicort Flexhaler, Alvesco, Aristocort, Kenalog-10, Kenalog-40, Azmacort, Pulmicort Turbuhaler

FDA Medwatch Alert: Singulair (montelukast)

Posted 27 Mar 2008 by Drugs.com

[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months ... Read more

Related support groups: Singulair

FDA Finds No Link So Far Between Asthma Drugs and Suicide Risk

Posted 14 Jan 2009 by Drugs.com

WEDNESDAY, Jan. 14 – An ongoing U.S. Food and Drug Administration safety review of possible suicidal behavior among those taking asthma drugs has found no evidence of a link so far, agency officials said Tuesday. The FDA, which began the review in March 2008, said clinical trial data submitted by the manufacturers of Singulair, Accolate and Zyflo suggest the products are not associated with an increased risk of mood changes or suicidal behavior. But, the agency also noted that the trials were not designed to examine such behavior, and that the safety review will continue, probably for several more months. "We have finished our analyses of all the data the companies submitted," FDA spokeswoman Karen Riley told the Associated Press. "But that doesn't mean we have closed the book on suicidality." According to Bloomberg News, Merck & Co submitted results from 41 placebo-controlled trials ... Read more

Related support groups: Singulair, Zyflo, Accolate, Zyflo CR

New Treatments Improve Control for Severe Asthma

Posted 16 Mar 2009 by Drugs.com

MONDAY, March 16 – Over just one decade, new asthma medications and tools have significantly improved the management of this serious airway disease. When compared to children treated in the mid-'90s, children with severe asthma during 2004 to 2007 were less likely to need oral steroids and rescue inhalers, and their lung function scores were improved, according to a study from National Jewish Health in Denver. "The current cohort was less likely to require chronic oral glucocorticoids, have better asthma control and have fewer glucocorticoid-induced adverse effects compared to a cohort of severe asthmatic children studied a decade ago," wrote the authors. Results of the study were expected to be presented Saturday at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, in Washington, D.C. To assess whether or not newer medications such as newer inhaled steroids, ... Read more

Related support groups: Asthma, Singulair, Asthma - Maintenance, Advair Diskus, Asthma - Acute, Advair HFA, Allergic Asthma, AccuNeb

Study Calls for Greater Scrutiny of 'Off-Label' Drug Use

Posted 24 Nov 2008 by Drugs.com

MONDAY, Nov. 24 – It's called "off-label" prescribing, and it's the common practice of doctors prescribing a drug to treat a disease or condition that's different from the one studied by federal regulators that led to the drug's approval in the first place. Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found. The study by American researchers has identified 14 widely prescribed medications that they think need additional study to see how effective and safe they are for off-label use. Many of the drugs are antidepressants and antipsychotics. "Off-label prescribing is not based on the same level of evidence as on-label prescribing," said study lead researcher Surrey Walton, an assistant professor of pharmacy administration at the University of Illinois at Chicago. Most patients aren't ... Read more

Related support groups: Lexapro, Zoloft, Cymbalta, Wellbutrin, Seroquel, Coumadin, Celebrex, Zyprexa, Risperdal, Singulair, Zestril, Epogen, Procrit, Prinivil, Desyrel

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