Assessment of Adverse Drug Reaction of Injectable Disease-Modifying Drugs in the Treatment Of Multiple Sclerosis (MS) Patients

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Introduction

Multiple Sclerosis (MS) is an inflammatory, demyelinating and debilitating autoimmune disease of the central nervous system (CNS),with Overcoming Woman gender which without effective cure and requires Lifetime treatment(1).

The purpose of Treatment in MS is to prevent recurrence and reduce the rate of neurologic Destruction.(2). Doctors generally prescribe disease-modifying drugs (DMDs) to reduce the frequency and severity of relapses in Multiple Sclerosis(3). DMDs (injectable drugs)contains IFN β-1a, IFN β-1b, Glatiramer acetate, Rituximab, Mitoxantrone, Natalizumab .The reported side effects of interferons include , alopecia and flu like syndrome ,mild anemia, variation of transaminases ,Local reaction and cutaneous necrosis, at the injection site, erythematous reactions , Necrotizing vasculopathic skin lesions, neuropathy, increase in spasticity ,livedo- reticularis and digital necrosis, Arthritis ,depression, and suicidal ideation ,headaches, Pneumonia(4-6)

The reported side effects of Glatiramer acetate include, nausea or vomiting skin rashes rapid heart rate, depression ,skin color changes, ,weight gain, anxiety, , body pain and weakness ,flushing ,breathing difficulties ,chest pain and (7).

The reported side effects of Mitoxantrone include, headache, heartburn, , diarrhea, nausea, vomiting constipation, unusual tiredness heavy menstrual bleeding, alopetia, , missed menstrual periods, runny nose, depressed mood(8).

The reported side effects of Rituximab include, fever, headache, nausea , diarrhea, heartburn flushing, weakness, chills stomach pain muscle or joint pain back pain ,dizziness(9).

The reported side effects of Natalizumab include joint or muscle pain, headache swelling hands/feet/ankles, redness or irritation at the injection site, skin rash changes in menstrual cycle, painful menstrual cramps diarrhea, depression, or cold symptoms, chest pain(10).

Due to the importance of adverse effects In clinical practice in the choice of medication Therefore, DMDs complications are compared in this article.

Materials and methods

Three hundred and sixteen MS patients (38male and 278 female) who were treated with DMDs (injectable drugs)contains IFN β-1a, IFN β-1b, Glatiramer acetate, Rituximab, Mitoxantrone, Natalizumab for at least 2 years were studied with cross sectional design (Patient checkup at a specified time interval (6-12 months).129. patients were treated with IFN β-1a and 49 patients were treated with IFN β-1b ,67 patients were treated with Mitoxantrone and 25 patients were treated with Rituximab and 16 patients were treated with Natalizumab and 30 patients were treated with Glatiramer acetate

Study populations were clinically definite MS patients who were consulted in Imam Khomeini clinic or in Sina hospital in Hamadan city.

At first clinically definite MS patients who were treated with Injectable DMDs for at 2 years patients in whom administration of drug were resulted in side effects, were evaluated. Clinical course and test results and MRI findings were reviewed (in 3-6-12-24 months intervals) by a competent neurologist and pharmacist.

Entry criteria included patient of 15–50 years with a clinical- or laboratory-supported diagnosis of relapsing MS and Secondary Progressive Multiple Sclerosis (11) should also have an Expanded Disability Status Scale(EDSS) 0-5 (12).Patients with EDSS above 5, were excluded from the study. Exclusion criteria included history of severe allergic or anaphylactic reaction to any DMD, or to other components of drug formulation, no evidence of , , cardiac, hepatic, renal, psychiatric, cancer , neurologic, hematologic ,auto-immune diseases, chronic diseases, endocrinologic, history of epilepsy و suicidal ideation , severe depression, enrollment, lactation and pregnancy as determined by history, physical examination, and screening blood tests.. Tenets of current version of the Declaration of Helsinki were followed, institutional ethical committee approval was granted, and the nature of the trial and possible side effects of the drugs were explained to the patient. After a detailed discussion with the neurologist, patients made a ﬁnal decision and each patient signed an informed consent. All 316 patients performed their treatment without interruption. To assess side effects, a questionnaire was prepared (in 3, 6, 12, 24 months intervals) completed for each patient. Eventually.The frequency of side effects was determined for each group and the collected data were compared in each treatment group.

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Assessment of Adverse Drug Reaction of Injectable Disease-Modifying Drugs in the Treatment Of Multiple Sclerosis (MS) Patients

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