Highlights
- Ozempic and Wegovy are experiencing shortages, leading to compounded versions of the drug which have not been tested or approved by the FDA.
- Semaglutide is still considered safe to use.
- Users should understand the risks associated with semaglutide and only purchase these medications with a prescription from a reputable pharmacy.
Ozempic and Wegovy — two products made from semaglutide — were believed to be the long-sought-after solution for people with type 2 diabetes. These medications have shown great promise for blood sugar control, lowering heart disease and stroke risk, and helping with weight loss.
However, these benefits have been overshadowed by a recent FDA warning about Ozempic. Now, current and potential patients are wondering whether the side effects are worth the benefits.
To help you make an informed decision, here’s what the FDA has shared about semaglutide, the active ingredient in Ozempic and Wegovny.
FDA Warns About Ozempic and Wegovy: What You Need to Know
The popularity of semaglutide medications like Ozempic and Wegovy have created a shortage of the drug in all forms (including pens and pills), leading patients and retailers to seek alternatives to satisfy the demand. One alternative has been the use of compounded medications.
On April 27, 2023, the FDA wrote to the National Association of Boards of Pharmacy expressing concerns about adverse effects of semaglutide that can occur when the medication is compounded with another drug.
Drug compounding is the process of mixing or combining two or more drugs to “customize” a drug for a patient. The FDA does not verify the effectiveness or safety of compounded drugs, and these compounds are not FDA-approved. There are also no FDA-approved generic versions of these drugs.
While the FDA is not specific about the adverse effects it’s concerned about, they revealed that they have received adverse event reports. They also explain that compounded versions of Ozempic and Wegovy may contain a salt form of semaglutide, such as semaglutide sodium or semaglutide acetate.
These salt forms contain different active ingredients compared to the drug’s pure form, and “they have not been found to be safe and effective.” Patients who are purchasing compounded semaglutide or “off-brand” versions due to the drug shortage could be at risk of unexpected side effects.
Are Ozempic and Wegovy Safe for You?
Despite the reports regarding compounded semaglutide, the FDA continues to consider the pure form of semaglutide safe and effective for certain groups of people.
Consult with your doctor to see if a prescription for Ozempic or Wegovny is right for you. Be sure to fill your prescriptions only with reputable, state-licensed pharmacies. Purchasing semaglutide from an unregulated source could result in your receiving a compounded form of the drug, which could put you at risk of adverse effects.
What Should I Do If I’m Taking a Compounded Version of Semaglutide?
If you are unsure if you’re taking a compounded version of semaglutide, ask the pharmacist where you filled the prescription. If you obtained semaglutide from a source without a prescription, there’s a good chance that the drug is a compounded version.
Be aware of the differences between the pure form of Ozempic and Wegovy vs a compounded version. Report any side effects to your healthcare provider. Avoid any future purchases of products purporting to be semaglutide that can be purchased without a prescription.
Patients experiencing unexpected side effects after taking Ozempic or Wegovy are encouraged to report their symptoms to the FDA’s MedWatch Adverse Event Reporting.
If you don’t have a prescription for Ozempic or Wegovy, talk to your doctor to see if it’s a good option for you. Your healthcare provider can write a prescription for you to fill at a reputable pharmacy and avoid the potential risks associated with compounded drugs.
Side Effects and Risks of Semaglutide
As with any prescription medication, even the FDA-approved versions of semaglutide carry some risks of side effects.
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Stomach pain
- Vivid dreams
- Hair loss
- Hypoglycemia
- Allergic reactions
- Gallbladder disease
- Kidney damage
- Pancreatitis (rare)
Less-serious side effects typically disappear within a few weeks. If you experience allergic reactions or signs of pancreatitis, seek immediate medical attention.
In addition to these potential side effects, a study has found that rodents taking semaglutide developed thyroid C-cell tumors. It’s unclear whether Ozempic causes thyroid cancer in humans.
A two-year trial of patients with type 2 diabetes and a high risk of cardiovascular disease showed that Ozempic was associated with higher rates of diabetic retinopathy, macular edema, and blurred vision than other medications of its class and other diabetes medications tested (such as metformin). The risk was greater among patients with a history of diabetic retinopathy compared to patients without a known history.
Alternatives to Semaglutide for Weight Loss
Ozempic and Wegovy are being sought after by individuals who desire to lose weight, but they were never meant to be a solution for everyone who wants to slim down.
Ozempic is not a weight-loss medication, and it has not been approved for this use. Rather, its intended use is to manage type 2 diabetes.
Wegovny is FDA-approved for weight management, but only for people who are overweight or obese AND have at least one weight-related medical condition.
With the shortage of the medication coupled with the risks of compounded versions, those seeking alternative weight-loss medications should consider other options.
The best alternative for most people is to make lifestyle changes that promote healthy weight loss, including:
- Eating whole, nutritious foods
- Drinking water
- Exercising at least 3 times per week
- Limiting your sugar intake
- Increasing protein intake
- Getting adequate sleep
- Living a more active lifestyle
Making lifestyle changes (instead of short-term dieting) can lead to long-lasting results.
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