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A 48-year-old man developed fatigue and lymphocytopenia with disseminated histoplasmosis while being treated for multiple sclerosis (MS) with glatiramer acetate, dimethyl fumarate, and fingolimod, as well as receiving the elasomeran COVID-19 vaccine. His symptoms were attributed to the medications and vaccine he was receiving, leading to hospitalization and a diagnosis of hypercalcemia. Treatment with IV fluids, amphotericin-B, and itraconazole resulted in rapid improvement, and he was eventually switched to glatiramer acetate for MS management. His condition improved over time, with stable MS and normalized lymphocyte counts. [Extracted from the article]

A 47-year-old woman experienced an exacerbation of pre-existing multiple sclerosis while undergoing treatment with dabrafenib and trametinib for stage IV malignant melanoma. Despite a stable disease course following previous MS treatments, the patient developed new lesions and elevated neurofilament light chain levels after starting the new medication regimen. Switching to ocrelizumab for MS treatment alongside continued dabrafenib and trametinib ultimately led to a reduction in MS disease activity and stabilization of oncologic follow-up. The exacerbation of MS was attributed to the use of dabrafenib and trametinib. [Extracted from the article]

In a retrospective study of 111 patients with head and neck cancer, three patients experienced adverse effects while being treated with pentoxifylline and tocopherol-acetate for osteoradionecrosis prophylaxis. The patients, who had all undergone radiotherapy and dental surgery, developed dizziness, malaise, and bleeding as a result of the treatment. The ages and genders of the patients were not disclosed in the report. [Extracted from the article]

A 25-year-old woman with multiple sclerosis (MS) experienced lack of efficacy and treatment noncompliance with fingolimod, unspecified steroids, and glatiramer acetate. She exhibited symptoms such as headaches, coordination difficulties, and falls, leading to a diagnosis of MS in 2011. Despite various treatments and relapses, her MS symptoms improved after switching HIV therapy and making medication adjustments. In 2023, she developed chronic back pain and urinary issues due to lumbar spinal stenosis. [Extracted from the article]

A recent communication from Teva Pharmaceuticals Ireland and Viatris Limited, in agreement with regulatory authorities, warns that anaphylactic reactions can occur shortly after or even years after starting treatment with glatiramer acetate for multiple sclerosis. Patients and caregivers are advised to be aware of the signs of anaphylaxis and seek immediate medical attention if necessary. Healthcare professionals in Ireland are urged to report any suspected adverse reactions to the appropriate authorities. [Extracted from the article]

A 50-year-old woman developed Nicolau syndrome, a rare skin condition, after receiving an injection of glatiramer-acetate for multiple sclerosis. She experienced skin discoloration, pain, and swelling in her left axilla and arm. The woman had a medical history of multiple sclerosis, epilepsy, and underactive thyroid, and had been receiving glatiramer acetate injections for over three years without any previous reactions. She was treated with antibiotics, dressings, and surgical debridement, and her skin eventually healed completely with scarring. [Extracted from the article]

A 36-year-old woman with multiple sclerosis (MS) developed progressive multifocal leukoencephalopathy (PML) while being treated with natalizumab. She also experienced lack of efficacy with dimethyl-fumarate and glatiramer-acetate for MS. The woman had been diagnosed with MS in 2002 and had previously been treated with interferon beta-1a. After being diagnosed with PML, she received plasma exchange and corticosteroids, and her MS treatment was switched to glatiramer acetate. However, her MS activity persisted, and she was then treated with dimethyl fumarate, which also showed lack of efficacy. Her treatment was subsequently switched to ocrelizumab and ofatumumab, and she did not experience a recurrence of PML. [Extracted from the article]

The Pharmacovigilance Risk Assessment Committee (PRAC) held a meeting in July 2024 and discussed several important topics. One of the highlights was the recommendation of new risk minimization measures for glucagon-like peptide-1 receptor-agonists (GLP-1 RAs) to reduce the risk of aspiration and pneumonia aspiration in patients undergoing surgery under general anesthesia or deep sedation. While the committee could not establish a causal association between GLP-1 analogues and aspiration, they recommended considering the risk of delayed gastric emptying before performing procedures under anesthesia or deep sedation. Additionally, the PRAC concluded that glatiramer acetate is associated with anaphylactic reactions, which can occur shortly after administration or even months or years after starting treatment. Healthcare professionals will be informed about this risk, and patients and caregivers will be advised to seek emergency care if an anaphylactic reaction occurs, with treatment with glatiramer acetate being discontinued in such cases. [Extracted from the article]

This article discusses two case studies of women with relapsing multiple sclerosis who experienced drug intolerance, injection site reactions, and lymphopenia during treatment with glatiramer-acetate and dimethyl-fumarate. The first patient, a 27-year-old woman, developed drug intolerance to glatiramer-acetate and lymphopenia with dimethyl-fumarate. The second patient, a 50-year-old woman, experienced an injection site reaction with glatiramer-acetate and lymphopenia with dimethyl-fumarate. Both patients discontinued dimethyl-fumarate and their lymphocyte counts returned to normal. They were subsequently treated with asphingosine 1-phosphate receptor modulator. [Extracted from the article]

The US FDA has issued a warning about the risk of medication errors when using incompatible autoinjectors for glatiramer acetate injection products. Using an autoinjector that is not compatible with a specific glatiramer acetate injection product can lead to missed doses or partial doses. Some glatiramer acetate injection products can be administered using an optional compatible autoinjector, while others must only be injected using a prefilled syringe. Patients are advised to confirm the compatibility of their autoinjector by consulting their healthcare professional, visiting the drug manufacturer's patient information website, contacting the drug manufacturer, or referring to the autoinjector labeling. It is important for patients to confirm compatibility each time they receive a new prescription for a glatiramer acetate injection product. [Extracted from the article]

The US FDA has issued a warning about the risk of medication errors when using incompatible autoinjectors for glatiramer acetate injection products. Using an autoinjector that is not compatible with a specific glatiramer acetate injection product can lead to missed doses or partial doses. Some glatiramer acetate injection products can be administered using an optional compatible autoinjector, while others must be injected using a prefilled syringe. Patients are advised to confirm the compatibility of their autoinjector by consulting their healthcare professional, visiting the drug manufacturer's patient information website, contacting the drug manufacturer, or referring to the autoinjector labeling. It is important for patients to confirm compatibility each time they receive a new prescription for a glatiramer acetate injection product. [Extracted from the article]

A 50-year-old woman developed Pneumocystis jirovecii pneumonia while undergoing immunosuppressive treatment for anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. She did not respond to treatment with cotrimoxazole for the pneumonia. The woman had a history of hemodialysis and had previously been treated for bacterial pneumonia and ANCA associated vasculitis. Despite receiving multiple treatments, including antibiotics and antifungals, she ultimately died from respiratory failure caused by Pneumocystis jirovecii pneumonia. The lack of efficacy of cotrimoxazole was noted in this case. The development of the pneumonia was attributed to the immunosuppressive medications she was taking. [Extracted from the article]

A 57-year-old woman with relapsing-remitting multiple sclerosis (RR-MS) experienced allergic reactions and drug-induced liver injury while undergoing various treatments. She initially received interferon-beta-1a, which caused liver injury and was discontinued. She then underwent treatment for breast cancer with tamoxifen, which also caused liver injury. Glatiramer-acetate, methylprednisolone, dimethyl-fumarate, and ocrelizumab were also associated with liver injury. However, her RR-MS was effectively controlled with ofatumumab therapy. [Extracted from the article]

A 33-year-old woman experienced a lack of effectiveness while being treated with prednisone acetate, estradiol, and dydrogesterone for secondary amenorrhea. She had been experiencing menstrual disorders for 15 years and had not menstruated since October 2014. Initially, congenital adrenal hyperplasia was suspected, but further investigations revealed that she had adrenocortical adenoma. After the tumor was removed, her menstruation resumed and she became pregnant three months later. [Extracted from the article]

A 49-year-old woman with multiple sclerosis developed normocomplementemic urticarial vasculitis while receiving treatment with glatiramer-acetate. She experienced recurrent urticarial rash around the injection sites, which worsened with subsequent injections and spread to other areas of her body. A biopsy confirmed the diagnosis of urticarial vasculitis. The woman's treatment with glatiramer-acetate was discontinued, and she was treated with triamcinolone and later transitioned to bilastine. [Extracted from the article]

A Canadian study published in Neurology found that disease-modifying drugs (DMDs) for multiple sclerosis (MS) can decrease the risk of hospitalization for infections but may increase the risk of infection-related physician visits. The study analyzed data from 35,894 MS patients in Canada from 1996 to 2017 and found that most DMDs were associated with a 42% to 61% reduction in the risk of infection-related hospitalizations. However, alemtuzumab increased the risk of infection-related physician visits by 33%, and dimethyl fumarate and fingolimod increased the risk by 10% to 13%. The study also identified other adverse effects associated with specific DMDs. The authors believe that these findings provide valuable insights into the risk-benefit profile of DMDs used in clinical practice for treating MS. [Extracted from the article]

Additionally, she exhibited lack of efficacy during treatment with methylprednisolone for MS during pregnancy [ I dosages and routes not stated i ]. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event An approximately 31-year-old woman developed rebound multiple sclerosis (MS) following withdrawal of natalizumab during pregnancy. Two weeks later, she was admitted to the department with severe dysarthria, right hemiparesis and sever truncal and limb ataxia, indicating rebound MS secondary to natalizumab withdrawal. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 16-year-old girl exhibited lack of efficacy during treatment with fingolimod, interferon- -1a and glatiramer acetate for relapsing-remitting multiple sclerosis (RRMS). The most recent blood count performed in April 2021 revealed an absolute neutrophil count of 1.1 × 10 SP 3 sp L. Based on these findings, the development of recurrent late-onset febrile neutropenia was attributed to ocrelizumab. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A woman in her 20s developed rebound relapsing-remitting multiple sclerosis (RR-MS) following cessation of natalizumab for MS. The woman was diagnosed with RR-MS and started a disease-modifying therapy with interferon -1a IM. [Extracted from the article]

Transtentorial herniation from tumefactive multiple sclerosis mimicking primary brain tumor. Because of increasing nature of lesion and oedema, her treatment with imunosuppressive therapies was continued and repeated neuroimaging was performed post few weeks duration of oedema resolution. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 50-year-old woman exhibited lack of efficacy with methylprednisolone, immune-globulin, unspecified steroids and glatiramer-acetate, while being treated for multiple sclerosis [ I not all routes and dosages stated i ]. [Extracted from the article]

Her treatment plan was 18 months of carbimazole with no intention for further treatment. Additionally, she developed grave's disease during treatment with alemtuzumab for MS [ I dosages and routes not stated i ]. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event SK, a 37-year-old woman exhibited lack of efficacy during treatment with interferon beta 1a and glatiramer acetate for multiple sclerosis (MS). [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 20-year-old woman experienced exacerbation of susac syndrome (SS) during treatment with interferon beta-1a and glatiramer-acetate for misdiagnosed multiple sclerosis [ I routes, dosages and duration of treatment to reaction onset not stated i ]. It was reported that she had been receiving interferon beta-1a for multiple sclerosis (MS). Manifestation of Susac syndrome during interferon beta-1a and glatiramer acetate treatment for misdiagnosed multiple sclerosis: a case report. [Extracted from the article]

FDA-approved glatiramer acetate injection products include Teva's Copaxone which is compatible the Autoject 2 device, the Sandoz product Glatopa which is compatible with Glatopaject, and the Viatris/Mylan glatiramer acetate injection which is compatible with WhisperJECT. The US FDA is warning that reusable autoinjector devices that are optional for use with glatiramer acetate injection products may not be compatible for use across all FDA-approved glatiramer acetate injection products. Users should contact their healthcare professional to confirm autoinjector compatibility each time they receive a new prescription for a glatiramer acetate injection product, or visit the drug manufacturer's patient information website to check autoinjector compatibility. [Extracted from the article]

Additionally, she developed acute respiratory distress syndrome (ARDS) during treatment with methylprednisolone for MS flare. Therefore, she was started on IV injection of methylprednisolone sodium succinate [methylprednisolone succinate] 1g for 3 days to control the exacerbated MS symptoms. [Extracted from the article]

A subset of women completed 1- and 12-month follow-up questionnaires that included pregnancy characteristics and outcomes, infant outcomes during first year of life, and breastfeeding practices. A review of the short- and long-term pregnancy, maternal, foetal, and infant outcomes following exposure to 20 and 40 mg/mL of glatiramer acetate during pregnancy and breastfeeding has found no evidence of adverse effects. [Extracted from the article]