FDA and Medical Disclaimer

Nexa Vitality, LLC operates this website and the membership platform, but does not provide medical services. Instead, Nexa Vitality, LLC connects you with healthcare providers licensed in your state who can offer medical weight loss services.

Compounded GLP-1 agonists have not been evaluated or approved by the US Food and Drug Administration (FDA) for safety, effectiveness, or quality. While compounding pharmacies are regulated at the state level, the FDA does not verify the safety, or effectiveness of compounded drugs.

This information is intended for educational and informational purposes only. It should not be used in place of an individual consultation, examination, or the medical advice of your healthcare provider. This information does not constitute the practice of medicine, and this information does not replace the advice of your healthcare provider, who should always be consulted before making any medical decisions.

Never disregard professional medical advice or delay seeking it because of something you have read here. Always consult with your healthcare provider before starting or stopping any medication. The use of any information provided on nexavitality.com is solely at your own risk.

The FDA has not evaluated or approved any statements made on this website, nor has it approved compounded medications to diagnose, treat, cure, or prevent any disease or medical condition.

GLP-1 receptor agonists, including semaglutide and tirzepatide, have been prescribed (on and off-label) for weight management, including obesity, along with a reduced-calorie diet and increased physical activity. Take precautions and read all warnings concerning GLP-1 medications, as they may cause serious side effects.

Important Safety Information for Semaglutide and Tirzepatide Medications

Warnings and Precautions

• Hypoglycemia Risk: Although GLP-1 agonists do not usually cause hypoglycemia when used alone, they can increase the risk when combined with other glucose-lowering medications. Monitor blood glucose levels regularly.
• Low Blood Sugar: GLP-1 agonists usually don’t cause low blood sugar, but if you are taking them with other medications to control your blood sugar, you might be at risk. Make sure to regularly check your blood sugar levels.
• Pancreatitis: Some people have reported getting pancreatitis (inflammation of the pancreas) when taking GLP-1 agonists. If you have severe stomach pain that won’t go away, with or without vomiting, stop taking the medicine and call your doctor right away.
• Allergic Reactions: Some people can have serious allergic reactions to GLP-1 agonists. If you get a rash, itching, or have trouble breathing after taking your medicine, stop taking it and get medical help immediately.
• Kidney Damage: There’s a small chance that GLP-1 agonists can harm your kidneys. Your doctor should regularly check how well your kidneys are working.
• Thyroid Tumors: Some GLP-1 agonists have been linked to a type of thyroid tumor. If you’ve had thyroid cancer or a condition called Multiple Endocrine Neoplasia syndrome type 2, you should not take GLP-1 agonists.
• Stomach Problems: If you have severe problems with your stomach or intestines, GLP-1 agonists might make them worse. Talk to your doctor about any stomach or bowel problems you’ve had in the past.
• Pregnancy and Breastfeeding: We’re not sure how GLP-1 agonists might affect an unborn or breastfeeding baby. If you’re pregnant, planning to get pregnant, or breastfeeding, make sure to discuss this with your doctor.
• Eye Problems: If you’ve had problems with your eyes due to diabetes, a sudden drop in your blood sugar can make them worse. If you have a history of diabetic eye disease, your doctor should keep a close watch on your eyes.
• Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical trials with other weight management products.
• Changes in Bowel Habits and Gastroparesis: Long-term changes in bowel habits, including chronic diarrhea or constipation and gastroparesis, have been reported after using GLP-1 receptor agonists.
• Changes in Facial Appearance: Some patients report an unusually thin, drawn, or saggy look to their facial features due to rapid weight loss.

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

Drug Interactions

• The addition of GLP-1 receptor agonists in patients treated with insulin has not been evaluated.
• Do not use multiple GLP-1 receptor agonist medications simultaneously.
• GLP-1 receptor agonists delay gastric emptying and can impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications you are also taking.
• The safety and effectiveness of GLP-1 receptor agonist medications in combination with other weight loss products, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Use in Specific Populations

• Pregnancy: GLP-1 receptor agonists may cause fetal harm. Discontinue all GLP-1 receptor agonist medications immediately upon recognizing pregnancy and at least 2 months before a planned pregnancy.