June 20, 2024

The millennial-skewed telehealth platform Hims & Hers this week joined several online pharmacies in offering customers a compounded version of semaglutide, the active ingredient in popular weight loss drugs like Ozempic and Wegovy.

The limited supply of these highly coveted and expensive brand name drugs has spurred several telehealth platforms to take advantage of a section of the Food, Drug, and Cosmetic Act that allows for the sale of compounded versions of medications that are in shortage.

Hims & Hers announced Monday that its customers will be able to get a prescription for the drug from a licensed health care provider directly on its platform. A month’s supply of the weight loss medication will start at $199 — hundreds of dollars cheaper than Ozempic’s nearly $1,000 list price and Wegovy’s $1,349 price tag.

Other online health platforms that hawk these unofficial medications include the male-focused Ro and Henry Meds — which also sells a compounded version of tirzepatide, the active ingredient in Zepbound.

Here is everything you need about compounded weight loss drugs.

What are compounded drugs?

Compounding is the process of customizing an approved drug by a state-licensed pharmacist or physician to meet the specific needs of an individual patient. The alterations of these medications can include making a higher dosage, reformulating a drug to not include ingredients a patient may be allergic to, and changing a pill into liquid form.

Outsourcing facilities can also compound drugs under the supervision of a licensed pharmacist.

There are about 7,500 pharmacies in the United States that focus on compounded drugs, according to the American Pharmacists Association.

Why are pharmacies allowed to make and sell compounded weight loss drugs?

Typically, the Food, Drug, and Cosmetic Act prohibits compounding drugs that are just copies of commercially available medications. However, drugs that are in shortage are not considered by the U.S. Food and Drug Administration (FDA) to be commercially available.

Wegovy and Eli Lilly’s weight loss drug Zepbound are both currently in shortage due to increased demand, according to an FDA database. Because of this, compounders are allowed to buy semaglutide and tirzepatide from drug ingredient makers to compound it into injectable formulations. These formulations could be mixed with B vitamins or L-carnitine.

Are there any risks?

The compounded formulations are not FDA-approved, so the agency does not review the safety and efficacy of these products.

In January, the FDA said it had received adverse event reports from patients taking a compounded semaglutide and recommended that patients not use a compounded drug if an approved drug is available. The agency specifically warned about reports of some compounders using salt forms of semaglutide — which is different from the semaglutide used in approved products like Wegovy — in their formulations.

On its website, Ro says its compounded semaglutide is made with semaglutide base and not semaglutide salts.

For its part, Hims & Hers said they conducted exhaustive research and vetting for over a year before partnering with a leading U.S. manufacturer of generic and compounded drugs. The company did not disclose the name of the manufacturer.

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *