Topline

Weight loss drug giant Novo Nordisk has received a warning letter from the U.S. Food and Drug Administration for failing to report side effects potentially linked to Ozempic usage, including two deaths and a suicide, according to a press release.

The logos of Danish drugmaker Novo Nordisk (Photo by Mads Claus Rasmussen / Ritzau Scanpix / AFP) / Denmark OUT (Photo by MADS CLAUS RASMUSSEN/Ritzau Scanpix/AFP via Getty Images)

Ritzau Scanpix/AFP via Getty ImagesKey Facts

The letter, which was sent on March 5th, pertained to semaglutide, which is the weight loss ingredient present in both Ozempic and Wegovy.

Novo Nordisk told Forbes that the cases “have been evaluated, and Novo Nordisk has ensured they are processed and reported appropriately,” but did not deny having failed to previously report them.

The company has sent the FDA “an initial response and seven updates,” according to the press release.

It does not expect this warning to impact production or investment guidance it recently outlined.

Big Number

27%. That’s how much Novo Nordisk’s stock has fallen year to date, based on its price of $38.32 on Tuesday afternoon. Regulatory scrutiny and increased competition from Mounjaro maker Eli Lilly have both contributed.

Tangent

Secretary of Health and Human Services Robert F. Kennedy Jr. has taken aim at Novo multiple times as part of his “Make America Healthy Again” campaign. In April of last year, he rejected a Biden-era proposal to expand Medicare coverage of GLP-1 obesity drugs to an estimated 7 million Americans. He also publicly criticized Ozempic as overpriced and unnecessary, claiming on Fox News that drugmakers are “counting on selling it to Americans because we’re so stupid and so addicted to drugs.”

Key Background

Novo Nordisk has faced multiple other regulatory communications in the past year. In December, the FDA sent a warning letter to Novo’s Bloomington, Indiana, manufacturing site for “significant violations” of Good Manufacturing Practice regulations after inspections found deficiencies in investigations of drug product failures and contamination risks. Last month, the FDA issued two letters criticizing Ozempic and Wegovy advertisements for containing “false or misleading claims” about efficacy and risk information. In a Feb. 26 letter, regulators accused Novo of using an ad to create “a misleading impression by framing Ozempic as superior” to similar drugs. Novo acknowledged these prior incidents in Tuesday’s press release, writing, “We work in a highly regulated space.”