Feds warn Ozempic and Wegovy maker over failure to report side-effects from weight-loss drugs
Millions of Americans use injectable drugs like Novo Nordisk’s Ozempic and Wegovy to help them lose weight – knowing there are possible side effects such as nausea, vomiting and diarrhea.
Now, the U.S. Food and Drug Administration has written a letter alleging that the Danish drugmaker failed to report adverse effects in patients who took semaglutide drugs, including death.
The March 5 letter cited three deaths in unidentified patients, including one patient who died by suicide, and Director of the Office of Scientific Investigations Dr. David Burrow wrote that Novo Nordisk had failed to failed to report “serious and unexpected” adverse drug experiences within the FDA’s required time frame.
“Based on your written procedure, your staff or contractor cancelled or rejected serious and unexpected adverse drug experiences that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product,” Burrow said.
However, the FDA stopped short in deciding whether any of the adverse effects were directly linked to the drug.
The findings were based on an inspection of a New Jersey facility last year that Burrow said “revealed serious violations” of reporting requirements.
Since then, Novo Nordisk had taken corrective and preventive actions that officials claimed were “inadequate” because the pharmaceutical giant “did not provide sufficient details to determine whether [Novo Nordisk’s] actions will effectively prevent similar violations in the future.”
The company was given 15 business days to address the “deficiencies” or face “regulatory action.”
In response to the FDA, Novo Nordisk released a statement earlier this week acknowledging the letter and saying it would continue to take steps to address the agency’s observations.
“The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,” Novo Nordisk said.
The drugmaker said it had received another warning letter after an inspection at a site in Bloomington, Indiana, late last year.
That inspection was related to the FDA’s Current Good Manufacturing Practice regulations, which ensure that a product is safe and that it has the ingredients and strength it claims to have.
“We have full confidence that we will be able to holistically and promptly address the matters outlined in each of the Warning Letters,” said Novo Nordisk.
