The Novo Nordisk pharmaceutical emblem is being displayed on a display alongside drugs and a medical … [+]
Weight-loss therapies like semaglutide (Ozempic) and tirzepatide (Mounjaro) have been game-changers for a lot of people searching for to handle their weight. Nonetheless, shortages and excessive prices have created vital limitations, prompting some sufferers to show to compounded variations of those drugs. However is utilizing compounded Ozempic protected?
Right here’s what you must know
Compounded drugs are custom-made to satisfy particular wants when commonplace prescriptions aren’t appropriate. They’re typically prescribed when a selected remedy, dose, or kind is not commercially obtainable. Compounding includes mixing exact quantities of lively and inactive elements based mostly on a health care provider’s prescription, permitting for tailor-made options.
There are over 7,000 compounding pharmacies and over 35,000 lively on-line pharmacies within the US. Typically, compounding a commercially obtainable drug shouldn’t be authorized until there is a medical necessity, reminiscent of a scarcity, discontinuation, or uncommon dosage, or an alternate formulation is required, reminiscent of a liquid formulation for many who have issue swallowing or to alter the flavour for kids. Moreover, if a affected person is allergic to an inactive ingredient in a drugs, a compounding pharmacist can produce the drug with out that ingredient. It’s necessary to notice that compounded medicine aren’t FDA-approved, elevating security and effectiveness issues.
Stricter rules had been enacted in 2013 after a fungal meningitis outbreak linked to improper sterile compounding. To mitigate dangers, compounding pharmacy accreditations have been established by the Pharmacy Compounding Accreditation Board (PCAB), the Nationwide Affiliation of Boards of Pharmacy (NABP), and the Joint Fee. State Boards of Pharmacy may additionally regulate compounding pharmacies to make sure security requirements are met. Nonetheless, the FDA doesn’t approve or monitor manufacturing of those drugs.
An Ozempic (semaglutide) injection pen is seen on a kitchen desk on August 6, 2023. (Photograph by Jaap … [+]
Why are individuals turning to compounded Ozempic?
Some individuals could also be turning to compounded Ozempic as a result of provide points. Injectable GLP-1 drugs, reminiscent of Ozempic and Mounjaro, have been in brief provide since 2022. Affordability is one other consideration, because the name-brand drugs can value $1,200 a month and will not be coated by insurance coverage. Sufferers might count on to over $14,000 a yr out-of-pocket, whereas compounded drugs could be cheaper.
At my very own weight reduction follow seeing sufferers at Bariendo, I do sometimes prescribe GLP1 drugs inside sure parameters. For instance, if a affected person has had ESG Abdomen Tightening carried out, I’ll prescribe a medication temporarily to assist optimize weight reduction. A recent study signifies that weight reduction drugs are simplest when initiated inside six months following ESG Abdomen Tightening. This strategy can result in a mean whole weight lack of 24%. Subsequently, it’s typically advisable to endure ESG Abdomen Tightening first. At current, we solely prescribe brand-name drugs reminiscent of Wegovy, Saxenda, Ozempic, Mounjaro, and Zepbound and don’t use compounded pharmacies with our sufferers.
The FDA permits the compounding of patented medicine like Ozempic and Mounjaro solely when there’s an official scarcity, as is at present the case with semaglutide and tirzepatide. Regardless of this, compounded medicine usually are not the identical as FDA-approved drugs. Whereas the FDA can authorize a drug for compounding, it doesn’t oversee the manufacturing course of or check the ultimate product for security and efficacy.
WHITE OAK, MD – JULY 20: An indication for the Meals And Drug Administration is seen outdoors of the … [+]
FDA warning about compounded Ozempic
In January 2024, the FDA posted a statement cautioning against the use of compounded semaglutide when the permitted model is out there. The company once more highlighted that it doesn’t evaluation compounded medicine for security, effectiveness, or high quality, and has obtained adversarial reviews from sufferers utilizing compounded semaglutide.
Novo Nordisk, the one FDA-approved producer of semaglutide, doesn’t promote the lively ingredient to compounding pharmacies. Some compounders could also be utilizing salt types of semaglutide, that are completely different from the lively ingredient utilized in permitted medicine like Ozempic and Wegovy.
The FDA warned: “The salt types are completely different lively elements than is used within the permitted medicine, which include the bottom type of semaglutide. The company shouldn’t be conscious of any foundation for compounding utilizing the salt types that will meet the FD&C necessities for kinds of lively elements that may be compounded.”
This lack of oversight and potential use of unapproved elements can result in severe penalties, together with contamination or incorrect dosages. The FDA has warned that some compounding pharmacies use unapproved beginning elements, resulting in potential adversarial occasions.
The Nationwide Affiliation of Boards of Pharmacy states that solely about 5% of the 35,000 lively on-line pharmacies adjust to U.S. pharmacy legal guidelines and follow requirements. Because of this many compounded drugs won’t meet important security and efficacy standards.
HUNTINGTON, UT – AUGUST 16: An ambulance leaves for the hospital.
Unsafe medicine sicken sufferers
Final yr, three individuals in the United States were hospitalized due to dangerously low blood sugar levels, linked to counterfeit variations of Novo Nordisk’s Ozempic, in accordance with the American Affiliation of Poison Management Facilities (AAPCC) as reported by Reuters.
All year long, the AAPCC recorded 3,316 calls associated to semaglutide, the lively part in Ozempic. This figure is more than double the previous year’s calls and represents a 15-fold increase since 2019, CNN reported.
Most of those calls had been as a result of extreme unwanted effects generally related to semaglutide, reminiscent of nausea, vomiting, and abdomen ache, which had been sometimes managed with intravenous fluids and anti-nausea drugs.
Within the three extreme circumstances of hypoglycemia, or low blood sugar, the AAPCC suspected the presence of counterfeit semaglutide. These incidents had been all reported by the identical regional poison management heart, one of many 55 within the U.S., in accordance with Reuters.
Moreover, final yr noticed a case of hypoglycemia in a person of a compounded model of Ozempic within the U.S. The FDA has famous that in drug shortages, such because the one affecting Ozempic, certified pharmacies are allowed to create compounded variations. Nonetheless, these variations usually are not topic to the rigorous testing and controls that branded drugs endure, making them probably unreliable.
Making certain remedy security
Customers must train warning when contemplating compounded drugs. Moreover, terribly low costs are sometimes too good to be true and will point out substandard or counterfeit merchandise.
To confirm the legitimacy of a compounding pharmacy, sufferers can use the FDA’s BeSafeRX program, which helps determine licensed and licensed pharmacies.