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), which is used to treat patients with multiple sclerosis (MS).

Copaxone was originated by Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) but the drug has now lost patent exclusivity. At peak, the drug was generating annual sales in excess of $1.3 billion, most of which came from the USA.

The FDA noted that this serious allergic reaction, called anaphylaxis, can occur at any time while on treatment, after the first dose or after doses administered months or years after starting the medicine. For most patients who experienced anaphylaxis with glatiramer acetate use, the symptoms appeared within one hour of injection.