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Combination pharmacotherapy, while sometimes used in clinical practice, is generally off-label with limited evidence in post-bariatric populations and requires careful monitoring

There is still a negative deflection for 9/12mg arms suggesting we have not reached max reduction in A1c and keep in mind this is retatrutide alone, with no other medications allowed

Lead plaintiffs' attorney Jonathan Orent told USA TODAY that the warning letter "gives me tremendous comfort both that we're right, but also that the government is actually now doing something about these problems." He compared the reporting failures to "the opioid days," noting that expert witnesses reviewing the case had "not seen anything quite that bad." Novo Nordisk responded that the letter "does not make any conclusions about the quality or safety of our medicines" and that the company plans to "address the requests in the warning letter expeditiously and holistically." What This Means for GLP-1 Litigation Strengthening Failure-to-Warn Claims The warning letter provides plaintiffs' attorneys with a critical piece of evidence: documentation that Novo Nordisk had institutional procedures that systematically prevented adverse events from reaching the FDA