Glucagon-like peptide-1 (GLP-1) receptor agonist drugs have been linked to side effect case reports on the FDA’s Adverse Event Reporting System (FAERS). Now, the drugs are included in an FDA review list, updated last on January 2.

Currently, the FDA is simply “evaluating the need for regulatory action”—drug companies are not yet being asked to do anything, such as updating warnings on their package labels.

The investigation was initially supposed to wrap in November, but the EMA’s committee recently sent “further lists of questions to be addressed” to companies marketing GLP-1 drugs. The committee is set to discuss the issue again in April.

Also commenting on the potential link between semaglutide—or Ozempic and Wegovy—and suicidal ideation, a study was published on January 5 that found that the drugs did not carry a higher risk of suicidal thoughts as compared to other type 2 diabetes and weight loss drugs.

As researchers and health officials continue to dig into GLP-1 drugs and any side effects not currently listed on their labels, experts agree that the review is not a cause for concern.

What’s the Link Between GLP-1 Drugs and Alopecia, Aspiration, and Suicidal Ideation? 

However, this FAERS reviewing system allows the FDA to stay on top of any new safety issues that come up, especially after a drug has been widely used by the public.

This review is simply the FDA “doing their due diligence,” he told Health.

Though there’s no confirmed causation between GLP-1 drugs and the three side effects named by the FDA, previous research has made connections between them. 

With suicidal ideation and weight loss drugs, in particular, there’s a history of concerns. Some weight loss drugs have even been previously removed from the market due to heightened risk of suicidal ideation, though it’s not totally clear why they may have this effect, Lofton said.

In general, the mechanism likely has something to do with the way that weight loss medications affect the central nervous system, which can, in turn, affect mood and suicidal ideation risk, Rafi explained.

It’s worth noting that Wegovy has suicidal ideation and behavior already listed as a warning on its prescribing information, he added.

There’s also an established connection between weight loss and hair loss.

“Alopecia specifically, as I understand it, is one of the more newer side effects people are investigating,” Rafi said. “Rapid weight loss can cause certain hormonal imbalances, as well as changes in a certain type of collagen.”

These changes could end up causing hair loss in some people, though again, more research is needed. However, this phenomenon has been observed in people who undergo a large amount of weight loss via sleeve gastrectomy.

Pulmonary aspiration—where food material, saliva, or some other substance accidentally enters a person’s airway and may end up in the lungs—has a less-defined relationship with GLP-1 drugs.

How Worried Should People Be About the Safety of GLP-1 Drugs?

For now, the FDA is just “evaluating the need for regulatory action,” so it’s not clear if anything will change with these drugs going forward.

This action could include “updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.”

This latter option is highly unlikely in the case of GLP-1 drugs, experts agreed. Even if there is some causal link that’s shown to exist between these side effects and GLP-1 drugs, that wouldn’t necessarily warrant making it unavailable, Rafi explained.

As for why these reviews are cropping up now, Lofton said it’s largely because of the “sheer mass of people who are taking some form of these drugs.” In other words, the number of adverse events is growing as the number of people taking the drug also increases. 

Though the FDA review is important, there’s no need for people to be “stressing out over it,” especially when, for now, there’s no proven link between GLP-1 drugs and alopecia, aspiration, or suicidal ideation, said Rafi. 

This is especially true for people who have already taken the medication and are seeing good results. 

“I have many patients who come in and they’ve been on these drugs for years with me, and they say, ‘I’m so worried about ileus.’ And I say, ‘Well, did you get ileus?’ ‘No, I didn’t get it.’ ‘Okay, well, then don’t worry,’” Lofton said.

However, patients or anyone considering taking Ozempic, Mounjaro, or a related drug should be aware of any potential risks and should be on the lookout for these or other side effects. This is especially true since every person’s experience on the medication is different, she added.

“As providers, we need to make sure to make patients aware of potential side effects, especially the serious ones,” said Lofton, “and then follow up with patients and make sure nothing untoward is putting them in a state where they have more risk than benefit.”