The FDA approved a higher-dose version of the weight loss drug Wegovy on March 19, clearing a 7.2 milligram weekly injection — three times the strength of the 2.4 mg dose that had been the standard since the drug's original approval. Novo Nordisk developed the stronger formulation for patients who don't reach their treatment goals at the lower dose.
The agency approved what is being called Wegovy HD just 54 days after filing. FDA Commissioner described the action as the agency "moving with unprecedented efficiency on products that advance national priorities." The drug had already received approval in the European Union and the United Kingdom before the U.S. decision.
Meghan Garcia-Webb, a physician triple board-certified in internal medicine, lifestyle medicine, and obesity medicine, called the approval cautiously promising. "Overall, the safety data showed that serious adverse events were actually a little bit lower for the 7.2 mg group, but as always, we will have to see how this plays out in real clinical practice," she told Healthline. Garcia-Webb was not involved in the clinical trial.
The FDA stated the higher dose carries a safety profile consistent with what is already known about semaglutide, the active ingredient in Wegovy. The most common side effects remain gastrointestinal — nausea, diarrhea, constipation, vomiting, and abdominal pain. At the higher dose, reports of altered skin sensations, including sensitivity, pain, and burning, occurred more frequently, though those effects generally resolve on their own or after a dose reduction. Garcia-Webb noted that side effect flare-ups during a dose increase often improve over the following weeks to months.
One emerging concern involves ischemic optic neuropathy, sometimes called an "eye stroke," which can cause sudden vision loss or blindness. Recent research found a potentially higher risk of the condition at elevated Wegovy doses, particularly in males. The mechanism may involve faster weight loss and greater systemic drug exposure affecting blood flow to the optic nerve. "There's still a lot of research to be done related to the risk of NAION and semaglutide," Garcia-Webb said. "It is wise to be especially cautious for patients who would be taking the highest dose." She advises patients with any pre-existing eye conditions to get clearance from an ophthalmologist before starting semaglutide.
