Glatiramer acetate, a drug approved in 1996, for the treatment of Multiple sclerosis, is currently facing increased scrutiny from the FDA due to serious concerns.
What is Multiple sclerosis?
Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system, specifically the brain and spinal cord. In MS, the immune system mistakenly attacks myelin, the protective sheath surrounding nerve fibers. This demyelination disrupts nerve impulse transmission, leading to various neurological symptoms like weakness, numbness, vision problems, and cognitive difficulties.
Relapses, also known as flare-ups or exacerbations, are common in many forms of MS. These are periods of new or worsening neurological symptoms. The frequency and severity of relapses vary greatly among individuals.
How does Glatiramer work against MS?
Glatiramer acetate is a medication used to treat people with relapsing forms of MS. It helps by calming down the body’s overactive immune system, which can mistakenly attack nerves in the brain and spinal cord. This helps to reduce the frequencies of MS relapses. Glatiramer acetate is given as a daily or three-times-weekly injection under the skin.
The case studies
From its approval in 1996 till 2023, almost 3 million patients were administered Glatiramer. Recently, the FDA reviewed reports of 82 serious allergic reactions (anaphylaxis) linked to glatiramer acetate. This included 51 hospitalizations, 13 intensive care unit admissions, and sadly, six deaths.
Though most reactions happened quickly after injection, recorded reactions varied from months to years after starting the first medication. Symptoms can include severe allergic reactions like difficulty breathing, low blood pressure, and even death.
Figure: Glatiramer acetate receives FDA warning (courtsey: glatirameracetatehcp.com)
The call for caution
On January 2025, FDA released an updated medication guide for the usage of this medicine, which warned both the patients and medical caregivers about the rare form of anaphylaxis post-injection. It is to be noted that the reactions, including wheezing or difficulty breathing, swelling of the face, lips, or throat, hives and severe rash are common post-injections, but are supposed to subside after a few minutes. In case these additional reactions such as flushing or warmth, chest pain, fast heartbeat, anxiety, breathing problems or tightness in the throat persist for a longer period of time, the patient and the caregivers need to be cautious.
While glatiramer acetate remains an important treatment option for many people with MS, this information empowers patients to make informed decisions about their treatment plan in collaboration with their healthcare providers. Open communication and careful monitoring are crucial for ensuring patient safety.
Avraneel Paul, Ph.D.
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