FDA Tacks Boxed Warning on Teva’s Copaxone, Other MS Drugs
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since December 1996 and six patient deaths.
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 warns of rare but serious allergic reaction with glatiramer
The US Food and Drug Administration (FDA) is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (marketed under trade names including Copaxone, Glatopa),
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.
FDA Adds Boxed Warning to MS Drug Copaxone
Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated with the use of Coxapone and the generic Glatopa that have resulted in hospitalization or death.
FDA Warns About Anaphylaxis Risk With MS Drug
The FDA added a boxed warning about rare cases of anaphylaxis associated with the multiple sclerosis (MS) drug glatiramer acetate (Copaxone, Glatopa), the agency announced on Wednesday. The warning indicates that anaphylaxis can occur at any time, from as early as after the first dose or after doses administered years after starting treatment.
FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases
The US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer acetate, a medicine for multiple sclerosis (MS). The agency issued the warning about the rare but serious risk of allergic reaction to the medicine,
FDA issues anaphylaxis warning on multiple sclerosis treatment
The FDA has advised health care professionals and patients with multiple sclerosis that treatment with glatiramer acetate is associated with a risk for anaphylaxis and issued a new boxed warning, according to a drug safety communication.
FDA: Anaphylaxis Risk Prompts Boxed Warning for MS Drug
Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
FDA Warns Of Severe Allergic Reaction Risk With Teva's Multiple Sclerosis Drug
FDA issues new warnings about rare but severe allergic reactions, including anaphylaxis, linked to MS drug glatiramer acetate, urging immediate medical attention.
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
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Industry Payments and Branded Glatiramer Acetate Prescribing in Medicare
The following is a summary of “Industry Payments and Branded Glatiramer Acetate Prescribing in the US Medicare Program,” ...
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 ...