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PPI Initiation in Sufferers Handled With Direct Oral Anticoagulants Examined

Posted in News on 24th November 2018

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FDA: Threat of Extreme Enhance in Incapacity Following MS Remedy Discontinuation

Posted in News on 23rd November 2018

November 21, 2018

In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing

In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing

The Food and Drug Administration (FDA) has issued a safety communication regarding the potential for disease worsening following the discontinuation of the multiple sclerosis treatment fingolimod (Gilenya; Novartis), which in rare cases may result in permanent disability. Fingolimod, a sphingosine 1-phosphate receptor modulator, was initially approved in 2010 to treat relapsing forms of MS. 

From September 2010 to February 2018, the FDA has identified 35 cases of severe increased disability accompanied by the presence of new lesions on MRI that occurred 2 to 24 weeks after stopping treatment with fingolimod; most of the disease worsening was observed in the first 12 weeks. The increase in disability was reportedly more severe than typical MS relapses and appeared unrelated to the patients’ prior disease state.

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In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing. Corticosteroids were given as the initial treatment for all 35 patients. Some had partial recovery (N=17), some had permanent disability or no recovery (N=8), and others (N=6) returned to the level of disability before or during fingolimod treatment. 

Prior to starting fingolimod, healthcare professionals should inform patients about the potential risk of severe disability after discontinuing treatment. If stopped, patients should be monitored for signs of disease exacerbation via MRI and be treated appropriately. Patients should seek immediate medical attention if new or worsening MS symptoms develop upon discontinuing fingolimod. Symptoms may include weakness, increased difficulty using arms or legs, or changes in thinking, eyesight or balance. 

The FDA has added a new warning regarding this risk to the drug labeling and patient Medication Guide for Gilenya.

For more information visit FDA.gov.

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FDA Cracks Down on Firms Promoting Dietary Dietary supplements Containing Tianeptine

Posted in News on 22nd November 2018

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Prescription Digital Therapeutic reSET Now Accessible for Sufferers With SUD

Posted in News on 21st November 2018

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New drug exhibits promise for treating individuals with peanut allergy

Posted in News on 20th November 2018

Managed ingestion of peanut protein might assist construct tolerance in peanut allergy victims. Authors of a brand new research printed within the New England Journal of Drugs say an oral immunotherapy drug they examined might be the primary FDA-approved remedy of its form for individuals with peanut allergy. The remedy, known as AR101, is derived from peanut protein.

“The outcomes of this landmark trial are more likely to result in the primary FDA-approved remedy for meals allergy in 2019,” mentioned Christina Ciaccio, MD, MSc, affiliate professor of pediatrics and medication at UChicago Drugs and research co-author. “At UChicago Drugs Comer Youngsters’s Hospital, we had been thrilled to be a part of this pivotal trial and for the chance to vary the lives of those kids and their households.”

Researchers in 10 international locations throughout North America and Europe carried out the trial, often called the Peanut Allergy Oral Immunotherapy Research of AR101 for Desensitization trial, or PALISADE, for brief. Of 496 eligible individuals ages four to 17, 372 obtained the AR101 oral remedy, whereas the rest obtained a placebo drug. On the finish of the trial, greater than two-thirds of the group taking the energetic drug had been in a position to tolerate a dose of peanut protein equal to about two peanut kernels.

“Virtually 6 million American kids are presently dwelling with a life-threatening meals allergy,” mentioned Ciaccio. “Each three minutes, a meals allergy response sends somebody to the emergency room, contributing to the whole annual value of caring for kids with meals allergy of practically $ 25 billion. Regardless of this, not a single remedy for meals allergy has been accredited by the FDA.”

In line with the research, oral immunotherapy for peanut allergy has been beneficial towards in most scientific settings as a result of previous trials have been restricted by small pattern sizes and differing methodologies. The PALISADE trial has proven, nevertheless, that oral immunotherapy is an affordable remedy possibility. Contributors of the PALISADE trial had been instructed to proceed the usual of look after peanut allergy, which meant eliminating peanuts from their diets and carrying self-injectable epinephrine (an emergency medical remedy for unintentional publicity).

Qualifying individuals began with a one-day supervised improve in dosage from zero.5 mg of peanut protein as much as 6 mg, a rise each two weeks from three mg to 240 mg and a 24-week “upkeep part” at 300 mg. When adversarial reactions occurred, the research protocol allowed for changes to the dosing schedule. In comparison with the placebo group, individuals who took AR101 had much less extreme allergy signs.

“Earlier than this remedy, households having been dwelling with fixed anxiousness that one flawed chunk will ship their beloved one to the emergency room, or worse. Now, we have now a security internet that we are able to present to children that may stop an allergic response in the event that they by chance take a chunk of a peanut-containing meals.”

Supply:

https://www.uchicagomedicine.org/forefront/pediatrics-articles/2018/november/researchers-find-promise-in-new-treatment-for-peanut-allergy

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