Important Safety Information

Effective Date: April 30, 2025
Last Updated: April 30, 2025

NavioMD connects patients with licensed providers for access to prescription treatments and wellness support. The information below outlines essential risks, usage guidance, and safety considerations for medications offered through NavioMD. This page is meant to empower you with knowledge—not just to inform, but to protect. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room.

Before You Begin Treatment

All treatments offered through NavioMD require a valid prescription and clinical approval by a licensed medical provider. Your treatment plan is never automatic. A licensed provider will assess your history, current medications, and risks before prescribing.

Medications—especially those that affect metabolism, hormones, or the cardiovascular system—carry potential side effects. It’s critical that you understand what those risks are, how to monitor them, and when to ask for help.

Prescription Medications Offered

FDA-Approved Medications

The following medications are FDA-approved and prescribed for weight loss, metabolic health, or hormone support when clinically appropriate:

  • Ozempic® (semaglutide)
    Prescribing Info PDF – Novo Nordisk
  • Mounjaro® (tirzepatide)
    Prescribing Info PDF – Eli Lilly
  • Zepbound® (tirzepatide)
    Prescribing Info PDF – Eli Lilly
  • Cyanocobalamin (Vitamin B-12)
    Prescribing Info PDF – FDA

These medications are only prescribed after a licensed provider confirms that the benefits outweigh the risks for your specific case. Your plan may include lab testing or additional monitoring as part of your safety protocol.

Compounded Medications

Some medications offered through NavioMD—such as compounded semaglutide, Biest, and DHEA—are custom-prepared by licensed 503A compounding pharmacies. These medications are not FDA-approved, and the FDA does not verify their safety, effectiveness, or quality.

However, compounded medications may be prescribed when:

  • FDA-approved versions are in shortage or unavailable
  • A patient needs a different formulation (e.g., oral vs injectable)
  • An individual medical need requires tailored dosing

All compounded medications at NavioMD are prescribed by a licensed provider and dispensed by a state-licensed compounding pharmacy following rigorous standards.

Learn more: FDA Q&A on Compounded Semaglutide

Serious Risks to Be Aware Of

⚠️ Boxed Warnings (GLP-1 Medications like Ozempic, Mounjaro, Zepbound):

  • Thyroid Tumors (including cancer): These medications have shown a risk of thyroid C-cell tumors in rodents. Human risk is unknown. Do not use if you or a family member has had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
  • Pancreatitis: Sudden, severe stomach pain (with or without vomiting) may be a sign. Seek immediate medical help.
  • Gallbladder Disease: Includes pain in the upper right abdomen, jaundice, or nausea.
  • Kidney Injury: Dehydration from nausea/vomiting can cause or worsen kidney issues.
  • Diabetic Retinopathy: May worsen vision in patients with type 2 diabetes.
  • Low Blood Sugar: Especially when taken with insulin or sulfonylureas.
  • Depression or Suicidal Ideation: Report any mood or behavioral changes to your provider.

Common Side Effects

These typically resolve with time as your body adjusts:

  • Nausea or vomiting
  • Diarrhea or constipation
  • Fatigue, dizziness, or headache
  • Decreased appetite
  • Stomach discomfort or bloating
  • Injection-site reactions (e.g., redness, swelling)

If symptoms persist or worsen, consult your provider promptly.

Who Should Not Take GLP-1 Medications?

Do not take if you have or have had:

  • Thyroid cancer or MEN2
  • Type 1 diabetes or diabetic ketoacidosis
  • A history of pancreatitis
  • Severe gastrointestinal disease (e.g., gastroparesis)
  • Current pregnancy or breastfeeding

Pregnancy & Family Planning

  • Do not take GLP-1 medications while pregnant or planning pregnancy.
  • These drugs must be discontinued at least 2 months before trying to conceive.
  • Talk to your provider about safe contraception options while on treatment.

Drug Interactions

Be transparent about everything you take—including supplements. GLP-1 medications can:

  • Slow down gastric emptying, affecting absorption of oral meds
  • Intensify effects of insulin or sulfonylureas
  • Require adjustments to thyroid medication
  • Interact with blood thinners, psychiatric medications, and other hormone therapies

Hormone Therapies (Biest, DHEA)

These treatments are commonly used to support symptoms of hormone deficiency or menopause, but they are not FDA-approved. They are formulated based on clinical evaluation and patient need.

Potential Risks:

  • Irregular bleeding
  • Breast tenderness
  • Mood changes
  • Blood clot risk (especially with estrogen-based products)

Contraindicated in:

  • Personal history of breast cancer or hormone-sensitive tumors
  • Liver disease
  • Uncontrolled hypertension
  • Pregnancy or nursing

Monitoring & Safety Expectations

As a NavioMD patient, you may be required to complete periodic check-ins, labs, or treatment reviews to continue your prescription. This is for your safety and the integrity of your care.

You are also encouraged to:

  • Keep a log of symptoms and side effects
  • Report any adverse reaction as soon as possible
  • Use a reliable contraceptive method during treatment (if applicable)
  • Stay hydrated, especially during initial dose escalation

Reporting Adverse Effects

You may report medication side effects directly to the FDA at www.fda.gov/medwatch or by calling 1‑800‑FDA‑1088. We strongly encourage contacting your NavioMD provider as well.

Trademark & Manufacturer Notes

Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S.
Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company.
NavioMD is not affiliated with or endorsed by any pharmaceutical manufacturer.

Still Have Questions?

Reach out—we are here to support your understanding.

📧 support@naviomd.com
📞 1‑877‑276‑2846
🏢 300 S Pine Island Rd, Suite 260, Plantation, FL 33324