NOVARTIS' Gilenya (fingolimod) Could Induce Severe Worsening of Multiple Sclerosis After Stopping the Medicine

FDA Drug Safety Announcement 

Severe Worsening of Multiple Sclerosis After Stopping the Medicine, NOVARTIS' Gilenya (fingolimod)

If you are a patient and has been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

• weakness
• trouble using arms or legs
• changes in thinking, eyesight or balance.

Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

Drug Label : One of many

AUDIENCE: Patient, Health Professional, Neurology, Pharmacy

ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

RECOMMENDATION:

Healthcare professionals should:

• Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.
• Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.
• Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.
• Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.
• Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.

Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

• weakness
• trouble using arms or legs
• changes in thinking, eyesight or balance.

Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

Meridian Bioscience, Inc's Alethia CMV Assay Test System Approved By FDA For Herpes Virus, cytomegalovirus (CMV) Detection In Newborns.

CMV-infected pneumocytes with large, intranuclear, basophilic inclusions with haloes at their periphery as well as small, granular cytoplasmic inclusions. Yale Rosen - Flickr

Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age.

“Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies, This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. 

The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.

The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA. The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience, Inc.

Cleaning Your Baby's Pacifire by Sucking on It, may Prevent Allergies.

If you thought that sucking a baby's pacifier to clean it and then popping it in the baby's mouth, whether you are doing it to your baby or someone else to their baby, is gross, better think again.
New research suggests a link between parental sucking on a pacifier and a lower allergic response among young children. This was revealed by the new research being presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting.

"We interviewed 128 mothers of infants multiple times over a period of 18 months and asked how they cleaned their child's pacifier. We found the children of mothers who sucked on the pacifier had lower IgE levels." #IgE is a type of antibody related to allergic responses in the body. Although there are exceptions, higher IgE levels indicate a higher risk of having allergies and allergic asthma."  says allergist Eliane Abou-Jaoude, MD, ACAAI member and lead author on the study conducted by Henry Ford Health System in Detroit. 

Further information about this study could be found at #ACAAI site.