FDA raises concerns over against popular anti-obesity drugs: The wider industry impact

FDA raises concerns over against popular anti-obesity drugs: The wider industry impact

FDA warns against popular anti-obesity drugs; including the one Elon Musk publicly admitted taking for weight loss and said that they can improve quality of life for Americans

It’s unknown how GLP-1 drugs may cause NAION. The condition is rare overall, occurring in somewhere between two and 10 people in 100,000 in the general population, according to the American Academy of Ophthalmology. In December 2024, Elon Musk showed off a trimmer figure in a holiday social media post while revealing that he has been taking an anti-obesity drug to shed weight.

He added, “Technically, Mounjaro, but that doesn’t have the same ring to it.” These small numbers have reportedly made it more difficult to determine with certainty if there is a connection. Tesla CEO posted a photo of himself on Twitter on Christmas Day dressed up in a Santa costume, captioning the picture, “Ozempic Santa.

FDA review of the available animal data did not identify a mechanism for how GLP-1 RA use could increase the potential risk of NAION.

The primary objective of the meta-analysis was to assess the incidence of NAION events in patients treated with GLP-1 RAs compared to the incidence in patients treated with a comparator (a placebo or a non-GLP-1 RA glucose-lowering medication). There were 126 such trials for GLP-1 RAs included in the meta-analysis, including a total of 134,253 patients (78,217 GLP-1 RA users and 56,036 patients receiving a comparator) with 288,879 PY of exposure (156,947 PY for the GLP-1 RA users and 131,932 PY for the patients receiving a comparator). We identified 15 probable NAION events, 10 in patients treated with GLP-1 RAs, 5 in patients receiving placebo, and none in patients who received other non-GLP-1 RA glucose-lowering medication. Overall, the results showed a NAION incidence rate of 6.4 events per 100,000 PY in patients treated with GLP-1 RAs compared to 3.8 events per 100,000 PY in comparator-treated patients.

Because of the small number or absence of cases of NAION observed in individual trials, fDA performed a meta-analysis of clinical trials across GLP-1 RA development programs.

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