The FDA has now approved multiple medicines for weight loss.

The drug company Novo Nordisk, headquartered in Denmark has created two injection-type drugs. The first is known as Wegovy. It is given as a once-weekly injection. The other is known as Ozempic and contains the same key ingredient as Wegovy, called semaglutide.

Eli Lilly’s injectable drug named Mounjaro has also been approved for Type 2 diabetes but is being used off-label for general weight loss.

Another Lilly drug, Orforglipron, is part of a new group of experimental medicines that goes after the same target, GLP-1, but in a daily pill form.

Novo Nordisk reported results last month showing that a pill version of semaglutide yielded 15% weight loss over 68 weeks, similar to the injectable Wegovy’s results.

But that drug, which is approved as Rybelsus for Type 2 diabetes, can be complicated to take, doctors say, with strict requirements about not eating or drinking within 30 minutes of taking it.

Pfizer has joined the race for the “magic weight loss pill” as well with two oral GLP-1 drugs in development, publishing data last month on one of them in people with type 2 diabetes; it also led to weight loss over 16 weeks that researchers said was comparable to other drugs in the class. The experimental medicines from Pfizer and Lilly are designed to be able to be taken with or without food.

The medicines still need to complete larger-scale testing in phase 3 trials, which means they are months to years from reaching the market.

So is this it? Have the drug companies finally created the “easy button” for weight loss? No more having to eat healthy? No more counting calories or macros? No more exercising needed to try and stay lean?

You know better than that, right?

Right out of the gate, there are several reason why you should be cautious about taking these weight loss medications.

• If you lose weight with new drugs, you likely will need to keep taking the medications forever to keep the weight off. People who stop taking Wegovy and Ozempic often gain weight back relatively quickly. Some have experienced addition gain from where they started.

• The drugs are expensive, and in general, insurance plans don’t cover them for weight loss (although they often do for people with diabetes). You could be looking at $15,000 to $17,000 a year for these drugs.

• The popularity of the new drugs has led to some shortages. So you could start taking it and then not be able to get it, leading to weight gain.

• The drugs can cause unpleasant gastrointestinal side effects (see below for details).

• A small percentage of people who take the drugs can suffer from a diabetes eye complication called retinopathy. Along with consulting with your primary care provider or endocrinologist, you should also see your eye doctor.

• The drugs tend to suppress a person’s appetite but to lose weight, you’ll still need to reduce your intake of desserts, sugar-sweetened beverages, and fatty foods. And, of course, exercise is important to keep your body healthy.

• Some people have complained about looking older due to “Wegovy or Ozempic face.” While many people taking weight loss drugs are pleased to shed some pounds, some say they’re dropping weight in the wrong place: their face. Some have complained of looking old and gaunt due to fat loss in the face.

While a sedentary lifestyle and increased consumption of empty-calorie, processed foods most certainly have boosted obesity rates in the U.S. and around the world, researchers have learned much more in recent years about genetic causes for weight gain. Some people’s bodies may, in fact, want them to pack on fat.

That being understood, there may be a small portion of the population that could benefit from a drug that reduces appetite and helps people lose significant pounds, leading to better overall health.

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How do they work?

Wegovy and Ozempic mimic a hormone called glucagon-like peptide-1, which targets areas of the brain that regulate appetite, according to the FDA authorization.

The drugs decrease appetite and slow down emptying of the stomach, so people feel less hungry and eat less. They can cause some unpleasant gastrointestinal side effects.

What the pharmaceutical companies have done is taken this hormone that is naturally occurring and restructured it into a drug. So, it's not a surprise that when people stop taking the medicine, they start to feel hungrier.

Normal hormone balance can be hard to get back. Some patients that stopped taking the drug reported that their appetite had increased. They no longer feels satisfied with small meals, struggle maintaining energy and gain weight.

Who is eligible? 

Under the FDA authorization, Wegovy is supposed to be used for people who are obese or overweight. Those who have a body mass index (or BMI) of 30 or greater are eligible along with those who have a BMI of 27 or greater who also have other health problems such as high blood pressure, diabetes or high cholesterol that make weight loss important. For reference, for a woman that is 5’4”, a weight of 175 pounds puts you at a BMI of 30. A 5’9” male has a BMI of 30 if he is 203 pounds.

They are also approved for people with Type 2 Diabetes.

If you don’t meet those criteria, you would be using the medications “off-label,” or not as the FDA has approved them. Your healthcare provider may or may not be ok prescribing a drug to you off-label.

What are the most common side effects?

Gastrointestinal problems are the most common side effects since Wegovy can slow down people’s digestive systems. During clinical trials, some participants experienced nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, bloating and gas.

People who have uncontrolled diabetes can get retinopathy, a complication that involves damage to blood vessels in the eyes, and can result in vision loss or blindness.

During the clinical trials for Ozempic, there was an almost three-fold increase in the rate of people getting retinopathy when they were placed on Ozempic as compared to those who were not receiving Ozempic.  

People may be at increased risk for pancreatitis, which is inflammation of the pancreas often caused by gall stones, alcohol use or high triglycerides.

The drug does carry a black box warning because in rodent studies it caused thyroid tumors. Because of this, Doctors may screen patients to find out if they have a family history of a specific kind of thyroid carcinoma, or another rare condition called multiple endocrine neoplasia syndrome type 2 (MEN 2).

If you take Wegovy or Ozempic to lose weight, will you need to keep taking the drugs indefinitely?

Yes. As with many chronic conditions, most people who use the drugs for diabetes or weight loss will need to keep taking them to keep benefiting from them.

You have to inject yourself with these drugs. As in stick yourself with a needle once a week.

These medications currently come as injectables, although as mention in the opening, there are pill forms being tested.

So what is the bottom line? Are they safe?

Just like any prescription or over the counter drugs, you always have to weigh the benefits and risks. In general, I’m not in favor of anything that seems to be the easy way out and involves messing with your body’s hormones for the rest of your life. However, if you are currently obese and are struggling with losing weight through a controlled diet, you are already at increased risk for many diseases. Heart disease is the leading cause of death in the U.S., and obesity and weight-related conditions are top risk factors.

As you would expect me to say, a clean diet (reduce sugar, grains and vegetable oils) and exercise should always be the first strategies to try and lose weight. But given that about 70% of Americans are overweight or obese, nearly half of adults in the U.S. have hypertension and more than 1 in 3 have pre-diabetes, these drugs may have their place.

You should learn the facts, talk to a trusted medical professional and make an informed decision.