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The FDA added it to injectable semaglutide in January 2025, and it climbs the dose axis like everything else. Burning or tingling skin tracks the dose, not the weight lost, and an active-comparator study put the risk about twice that of another weight-loss drug. The mechanism is unsettled: the tempting "it is the drugs signaling arm" story is ruled out, because the strongest GLP-1 signaler in the class carries no such signal

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However, the list includes an S0 category for pharmacological substances that are not addressed elsewhere and have no current approval by a governmental regulatory health authority for human therapeutic use

These cases were due to allergies to cobalt molecules or other ingredients in the supplements, like benzyl alcohol