FDA adds boxed warning to multiple sclerosis drugs

FDA warns of serious allergic reactions with some multiple sclerosis drugs
The U.S. Food and Drug Administration on Wednesday warned about the risk of a rare but serious allergic reaction with the use of some multiple sclerosis drugs including Teva's Copaxone. The health regulator is adding a new boxed warning,
Teva's multiple sclerosis stalwart Copaxone gets FDA boxed warning for anaphylaxis risk
After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in the form of a safety-related boxed warning. | More than 80 cases of treatment-associated anaphylaxis have been reported since 1996,
FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases
Teva Pharmaceutical’s Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that affects the central nervous system. Glatopa, a generic version of Teva’s product, was approved by the FDA this year and marketed by Sandoz. The drugs have demonstrated a 34% drop in the number of relapses compared to placebo.
FDA Warns of Severe Allergic Reactions With Certain Multiple Sclerosis Drugs
The FDA issued a boxed warning for anaphylaxis risk linked to Glatiramer acetate and Glatopa, used in MS treatment. Anaphylaxis symptoms can appear within an hour of injection and may lead to severe conditions,
FDA adds boxed warning to Teva’s Copaxone for allergic reaction
The Food and Drug Administration is adding a boxed warning about the risk of an allergic reaction for Teva‘s (TEVA) Copaxone and Sandoz’s
FDA issues warning on anaphylaxis risk with MS drugs
Symptoms of anaphylaxis typically develop within an hour of injection and can include wheezing, difficulty breathing, swelling of the face or throat and hives. In some cases, the reaction can lead to hospitalization or death.
HealthDay on MSN6h
Multiple Sclerosis May Worsen With Menopause Transition
The menopausal transition may represent an inflection point for worsening of multiple sclerosis (MS) in women, accordi ...
MedPage Today on MSN9h
Mothers With MS Have Higher Incidence of Mental Illness
The incidence of mental illness was higher among women with MS during both the prenatal period (incidence ratio [IR] 1.26, 95 ...
FOX 9 Minneapolis-St. Paul on MSN3h
Edina, Minnetonka high school basketball rivals team up to ‘beat’ MS
The Minnetonka and Edina Girls Basketball teams are rivals on the court, but now they are joining forces to defeat a common ...
New Study Links Multiple Sclerosis to Increased Mental Health Risks During and After Pregnancy
A new study reveals that people with multiple sclerosis (MS) experience significantly higher rates of mental illness during ...
COVID-19 Doesn't Worsen Multiple Sclerosis, Study Says
Earlier studies indicated that COVID infection might cause MS symptoms to worsen, particularly if the symptoms coincide with those associated with long COVID. For this new study, researchers tracked ...
Onlymyhealth9d
Menopause May Increase The Progression Of Multiple Sclerosis In Women, Study Warns
A recent study shows that menopause may worsen Multiple Sclerosis symptoms and accelerate its progression due to a decline in ...
Tiziana Life Sciences Announces Discovery of New Immune Biomarkers in Multiple Sclerosis Patients Treated with Nasal Foralumab
The study identified gene expression changes which were detected beginning three months after intranasal dosing of foralumab in our ongoing ISPPEA (or expanded access program). Key findings include ...
FDA warns of serious allergic reactions with multiple sclerosis drugs
The U.S. Food and Drug Administration on Wednesday warned about the risk of a rare but serious allergic reaction with the use ...
Medscape20h
Stop Disease-Modifying Therapy in Stable MS: Yes or No?
MS patients who achieve long-term stable disease on disease-modifying therapy may want to stop their medication for varying ...