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Weekly Drug News Round Up - October 16, 2013

FDA Approves Sanofi's Nasacort Allergy 24HR for Over-the-Counter Use

Nasacort Allergy 24HR is the first OTC nasal corticosteroid approved for use in allergies; available on shelves in the spring Read More…

Each year, up to 60 million Americans suffer from seasonal and year-round nasal allergies. The U.S. Food and Drug Administration has approved the Rx-to-OTC switch of Sanofi’s Nasacort (triamcinolone) for over-the-counter (OTC) treatment of nasal allergies in adults and children 2 years of age and older. Nasacort Allergy 24HR, a nasal corticosteroid, is in the class of drugs considered the most effective treatment for hay fever and other upper respiratory allergies. Nasacort AQ is also available generically as triamcinolone with a prescription. Similar treatments in this class that are still available only by prescription and brand name include Rhinocort Aqua (budesonide), Flonase and Veramyst (fluticasone), and Nasonex (mometasone).

Leukemia Drug Iclusig: Blood Clots Are a Concern

FDA is currently evaluating these adverse events and will notify the public when more information is available Read More...

The U.S. Food and Drug Administration (FDA) is investigating reports of serious and life-threatening blood clots and severe narrowing of blood vessels in patients taking the leukemia chemotherapy drug Iclusig (ponatinib). Blood clots have been previously reported with Iclusig and are reported in the product labeling. In clinical trials conducted before approval, serious arterial and venous blood clots occurred in 8 and 3 percent of Iclusig-treated patients, respectively. Current clinical trial data suggests that at least 20 percent of all participants treated with Iclusig have developed blood clots or vessel narrowing. Patients taking Iclusig should seek immediate medical attention if they experience symptoms suggesting a heart attack or stroke.

Vitamin D Alone May Not Prevent Weak Bones

Nearly half of all people aged 50 and older use vitamin D supplements Read More...

A new study from the University of Auckland in New Zealand strengthens evidence that taking vitamin D alone does not improved bone mineral density to prevent osteoporosis. In the study published in The Lancet, the only significant increase in bone density (0.8 percent) was seen at the neck of the thigh (femoral) bone. Researchers looked at data from 23 studies that included a total of more than 4,000 healthy adults with an average age of 59. Experts state there is very little harm from taking normal doses of vitamin D supplements, but the added economic costs might not make it worthwhile for some patients.

Antares Pharma Receives FDA-Approval for Injectable Otrexup

Patients may have inadequate effectiveness or be intolerant to oral methotrexate tablets Read More...

The U.S. Food and Drug Administration (FDA) has approved Otrexup, a new technology for the subcutaneous (SC) self-injection of methotrexate (MTX), the gold standard in rheumatoid arthritis (RA) therapy. Otrexup has been approved for treatment of more severe forms of RA, juvenile RA, and psoriasis. Data submitted to the FDA demonstrated an increased bioavailability of SC MTX compared to oral MTX at every dose. Otrexup is delivered once weekly via the proprietary Vibex Medi-Jet technology. Studies have shown that the self-injection device is easy to use, even for patients with RA in their hands. Commercial availability is expected in early 2014.

Anti-Smoking Drugs Do Not Increase Suicide Risk: Study

New study data contradicts an FDA boxed warning on anti-smoking drugs for an increased risk of depression and suicidality  Read More...

A new study in BMJ provides evidence that people who use anti-smoking medications such as Chantix (varenicline) and Zyban (bupropion) do not have an increased the risk of depression or suicide compared to those who use nicotine replacement therapies such as Nicorette or Nicoderm CQ. In the study researchers analyzed data from more than 119,000 British adults. Of those patients, about 26 percent used Chantix, around 6 percent tried Zyban and more than two-thirds used nicotine replacement therapies, such as patches and gum. There was no clear evidence that people who took Chantix or Zyban were more likely to experience depression or suicidal behavior.