Horizon adds ‘severe hearing impairment’ warning to blockbuster’s label

The FDA re­cent­ly added a new warn­ing and pre­cau­tion to the la­bel of Hori­zon’s block­buster mon­o­clon­al an­ti­body Te­pez­za (tepro­tu­mum­ab-trbw), which is used as a treat­ment for thy­roid eye dis­ease, to cau­tion pa­tients about the po­ten­tial for se­vere hear­ing-re­lat­ed side ef­fects.

The la­bel for Te­pez­za, an in­sulin-like growth fac­tor-1 re­cep­tor in­hibitor that can re­duce eye bulging and dou­ble vi­sion, now says the drug “may cause se­vere hear­ing im­pair­ment in­clud­ing hear­ing loss, which in some cas­es may be per­ma­nent.”

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