FDA, MS and Copaxone

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 issues warning on anaphylaxis risk with MS drugs
The FDA has added a boxed warning, its most serious designation, to Copaxone and Glatopa due to the risk of anaphylaxis, a rare but serious allergic reaction. This severe reaction can occur at any time during treatment, including months or years after starting the drug, according to a Jan. 22 news release from the agency.
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 Warns of Severe Allergic Reactions With Certain Multiple Sclerosis Drugs
Today, the FDA issued a warning about the risk of anaphylaxis, a rare but life-threatening allergic reaction, linked to certain multiple sclerosis (MS) drugs, including glatiramer acetate (Copaxone; Teva) and its generic counterpart, Glatopa, sold by Sandoz. 1
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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