Novo Warned on Lax Reporting of Ozempic Side Effects, Deaths (1)

Novo Nordisk A/S got a warning letter from the US Food and Drug Administration for not reporting all suspected side effects in patients who took its blockbuster diabetes drug Ozempic.

Among the cases were two deaths and a suicide, the agency said in a March 5 letter and accompanying report. The FDA didn’t stipulate whether the deaths or other side effects were linked to the drug.

Novo said it plans to address the FDA’s concerns “expeditiously and holistically.” It’s been working with the agency on an action plan since an inspection early last year, the company said in a ...