According to the MEB, it is known that patients can experience allergic reactions after injections under the skin with glatiramer acetate, including rash and fainting. An anaphylactic reaction may occur shortly after administration of this medicine.
Research in the European Union using all available data on glatiramer acetate worldwide has shown that these anaphylactic reactions can also occur in patients who have been receive the medicine for months or even years.
The medicinal authority emphasizes that allergic reactions must be distinguished from post-injection reactions, which may include redness of the chest or the face, shortness of breath, chest pain and rapid heartbeat. These reactions usually do not cause any problems and disappear after thirty minutes. If the problems last longer, the patient must go to the hospital.
Emergency care
Health care providers are advised to inform patients and their caregivers of the signs and symptoms of anaphylactic reactions and to seek emergency medical care immediately if they occur. Treatment with glatiramer acetate must be stopped immediately.
Symptoms of an anaphylactic reaction include: widespread rash (red spots or hives), swelling of the eyelids, face, lips, mouth, throat or tongue, sudden shortness of breath and vomiting.
Risk information
In consultation with the European Medicines Agency (EMA), the MEB and the Health and Youth Care Inspectorate, the joint marketing authorities of Direct Healthcare Professional Communication (DHPC) with risk information on this topic to, among others, the following health care providers. : neurologists and pediatric neurologists, public pharmacists, hospital pharmacists and emergency room doctors.
2024-08-15 11:12:26
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