Safe Medication Use | Overview
We are committed to our patients’ health and safety, and we want to make you aware of a few important things about weight management medications that are not FDA-approved.
Watch for medications that are not FDA-approved
You may have heard that medications for weight management are often in short supply, especially newer medications like semaglutide or tirzepatide. As a result, many companies are selling obesity medications directly to consumers. Please know that these websites are often selling versions of medications which are not FDA-approved — even if they are endorsed by medical doctors.
Potential side effects of non-approved drugs
Many of these drugs contain a chemical that is marketed as something similar to what’s found in drugs like Wegovy or Zepbound. But these are not the same as the brand-name medications that are FDA-approved. These medications may not have the same chemical, and therefore may have different side effects and risks. These medications also may be mixed in a way that alters their safety and efficacy and could contain toxic ingredients.
Online medication purchases are risky
Buying medications online is risky, and the only way to ensure you are getting genuine FDA-approved medication is to have your physician send a prescription to a licensed pharmacy. If you have any questions or are worried about cost, please talk to your medical team. We are here to help.
Don’t accept weight management medication in a vial
Genuine semaglutide, liraglutide, or tirzepatide will only ever be dispensed in a pen. If you receive a vial of any of these medications, be aware that this is not an FDA-approved formulation. When in doubt, bring your medications with you to your appointment or send us a photo in the portal.
An exception is a newer, out-of-pocket (i.e., not covered by insurance) formulation of certain doses of tirzepatide sold by Eli Lilly. This is a newer option, and we generally prefer to prescribe medications covered by insurance.
Generic and non-FDA approved medications are different
Non-FDA approved medications are very different from generic medications, which are approved by the FDA. We hope that generic forms of semaglutide, tirzepatide, and liraglutide will be available in the near future and may help to reduce the burden of co-pays and insurance paperwork.
What does it mean to be FDA-approved?
Medications that are approved by the U.S. Food and Drug Administration (FDA) have undergone extensive testing in human patients and are backed by extensive safety data. Some medications are FDA-approved for a particular disease, meaning that they have been rigorously tested in a particular age group and have received approval for this indication.
Using an FDA-approved ‘off-label’ medication
Our team may discuss with you the option of using an FDA-approved medication in an “off-label” manner. This means that although the medication has been studied and tested, it may not be approved for use in a particular age group or for a certain disease. Whether or not you use medication in this way should be a discussion between you and your medical team. However, this practice is very different from using compounded medications because all of these drugs have been approved by the FDA for use in humans and have safety data from clinical studies.
Learn more
- https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
- https://obesitymedicine.org/blog/obesity-medicine-association-issues-a-position-statement-on-compounded-peptides/
- https://www.wegovy.com/coverage-and-savings/get-wegotogether-support.html