US EditionFDA Sends Warning Letter to Maker of Ozempic, Wegovy over Unreported Potential GLP-1 Side Effects
The FDA cited Novo Nordisk for serious reporting violations including three deaths and delayed reviews of side effects for semaglutide, a drug used for diabetes and weight loss.
- On March 5, the U.S. Food and Drug Administration sent a warning letter to Novo Nordisk alleging failures to timely report adverse events for semaglutide products Ozempic and Wegovy.
- An inspection from Jan. 13 to Feb. 7, 2025 found serious violations at Novo Nordisk's New Jersey site, and Novo Nordisk said on March 10 it has been addressing the FDA's observations since February 2025.
- The warning letter details specific lapses such as missing a valid patient identifier within 15 days for a male patient death, a Dec. 16, 2024 report medically reviewed only on Feb. 3, 2025, and missing the 10-day medical-review requirement for suicidal ideation.
- Novo Nordisk must respond within 15 business days to detail how it will prevent future violations after the FDA called corrective measures inadequate and warned regulatory action is possible.
- The FDA did not say whether the deaths among semaglutide patients, including one suicide, were drug-related, as reports to the BBB's scam tracker spiked in recent weeks.
28 Articles
28 Articles
FDA sends warning letter to maker of Ozempic, Wegovy over unreported potential GLP-1 side effects
The FDA sent a warning letter this month to Novo Nordisk, alleging the drugmaker failed to report, in a timely manner, potential side effects in patients who took its popular medications containing semiglutide.
FDA issues warning letter to Novo Nordisk for improper reporting of GLP-1 adverse events
The FDA has issued a warning letter to Novo Nordisk for violating postmarketing adverse drug experience regulations that include failure to report adverse events among patients taking GLP-1s. In the warning letter, the FDA said it uncovered “serious violations” of postmarketing adverse drug experience regulations following an inspection conducted at company headquarters from Jan. 13, 2025, to
What did the FDA warn Novo Nordisk about?
FDA raises concerns about safety reporting at a leading GLP‑1 maker Federal regulators issued a formal warning to the maker of two blockbuster GLP‑1 medicines used for diabetes and weight loss, saying the company failed to submit reports about suspected adverse events in a timely and complete way.…
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