Fingolimod Brand Gilenya for Multiple Sclerosis increases heart risksFINGOLIMOD, a medicine for multiple sclerosis manufactured by Pharma company Novartis under the brand name Gilenya is labelled as dangerous because of the possible risks of development of diseases of the heart and thus, they have added the stronger warnings on the label of the medicine packaging.The warnings now mention having an Electrocardiogram (Graphical presentation of heart activity) before taking having the first dose of Gilenya and six hours after having the medicine. Patients having Fingolimod (Gilenya) for the first time must be admitted in a hospital for observation purpose and should have the ECG and blood pressure monitored by the doctor for safety purposes.These changes in the warnings information came up following a Food and Drugs Administration Department (FDA) report in December 2011 on the medicine about a patient of multiple sclerosis who died within the first 24 hours of taking Gilenya. While Gilenya is not yet completely held responsible for the death of the patient, investigations are still going on to find out the cause of death.New patients of multiple sclerosis using Fingolimod are known to experience dizziness and tiredness with fatigue in the first month of use of the medicine. They may also feel palpitations in the heart region and pain in the chest which gets better in the first 24 hours of taking the first doses of Gilenya. All these troubles are caused due to slowing of the rate of the heart.The United States Health Department will also recommend that certain people suffering with specific heart related disease conditions must be monitored by a physician / health professional after taking their first dose of Fingolimod for their troubles of Multiple Sclerosis.Multiple Sclerosis is a disease which affects the brain and the spinal cord where there is auto killing of the cells by the disease fighting system the immune system of the body. As a result, people suffering from multiple sclerosis experience weakness in one or more limbs, imbalance of the body and numbness. According to the National Multiple Sclerosis Society, about 400,000 Americans have Multiple Sclerosis.Risks versus Benefits of Gilenya FingolimodGilenya is prepared in a way that it is taken only a once a day by mouth. This is in favor of the patients tired of taking many medicines in a day for Multiple sclerosis. It also reduces the flares and troubles because of relapse of multiple sclerosis, which at most of the times is inevitable. Fingolimod was approved for use by the FDA in September 2010.Fingolimod Gilenya is the first medicine for Multiple Sclerosis which is taken by mouth. Medicines till now were needed to be taken by injections which are painful.The bad side of the medicine is that it can reduce the number of White blood cells in the blood which are responsible forThe drug is also known to lower the number of white blood cells in the blood, so another possible side effect of Gilenya is an increased risk of serious infection. It may also cause vision, breathing, or liver problems in some people.Another movement came from the non-profit watchdog group The Institute for Safe Medication Practices (I.S.M.P.), who have urged for more restrictions on the use and dosage of Fingolimod. They submitted their drug report of Fingolimod to the FDA MedWatch program in the second quarter of 2011 to substantially restrict the use of Gilenya and to enhance the monitoring of the overall brand by Novartis.Gilenya represents an important treatment option for relapsing forms of MS, says Barry Singer, MD, director of the Multiple Sclerosis Center for Innovations in Care at Missouri Baptist Medical Center, in a statement. Choosing appropriate patients for Gilenya therapy and patient safety is essential.
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ReplyDeletenice to read it thanks for posting