by Brenda Baletti, Ph.D., Childrens Health Defense:
The FDA reprimanded Novo Nordisk for “serious violations” in failing to report serious side effects tied to its blockbuster GLP-1 drugs, including Ozempic and Wegovy. Investigators said the company didn’t report cases involving strokes, suicidality and patient deaths, raising concerns about systemic problems in its drug safety monitoring.
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The maker of several blockbuster weight-loss drugs failed to report serious side effects, including strokes, suicidal ideation and deaths, according to the U.S. Food and Drug Administration (FDA).
The FDA this month issued a formal warning letter to Novo Nordisk, reprimanding the pharmaceutical giant for “serious violations” in failing to report serious side effects linked to Ozempic, Wegovy and Saxenda.
The March 5 letter followed FDA inspections, conducted in January and February, of Novo Nordisk’s U.S. operations in Plainsboro, New Jersey.
Investigators concluded the company failed to comply with federal regulations governing the reporting of post-marketing adverse drug experiences (PADE) — a critical safety system used to detect safety signals after the drugs are already on the market.
Under federal law, pharmaceutical companies must promptly report all serious reports of adverse events to the FDA within 15 days of receiving the report, so regulators can monitor emerging risks to consumers.
However, Novo Nordisk — in violation of the law — chose not to report serious adverse events, including strokes and patient deaths, after their staff or contractors decided the side effects weren’t related to the drugs.
Investigators found the drugmaker also failed to follow some of its own internal procedures, including making follow-up attempts to obtain safety information for serious cases involving reported deaths.
In post-inspection correspondence with the agency, the company said it was taking “corrective and preventative actions” to address the violations.
Still, the FDA slapped the company with the warning letter because it said Novo’s response did not provide sufficient details to demonstrate whether those actions would effectively resolve the issues.
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