Off-Label Semaglutide Linked to Deaths, Hospitalizations Calling for Compounding Regulation
Pharmacy Times
NOVEMBER 8, 2024
Off-label semaglutide has been linked to serious adverse effects, calling for increased regulation around compounding.
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Pharmacy Times
NOVEMBER 8, 2024
Off-label semaglutide has been linked to serious adverse effects, calling for increased regulation around compounding.
The Checkup by Singlecare
DECEMBER 19, 2024
As a result, the use of medications like Ozempic , Wegovy , Zepbound , Rybelsus , and Mounjaro has skyrocketed, as people turned to these medications to help them lose weightcausing drug shortages and creating a market for compounded versions of these brand-name drugs. RELATED: Is compounded semaglutide safe? But the U.S.
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Hospital Pharmacy Europe
JANUARY 16, 2025
A new global study from the International Pharmaceutical Federation (FIP)s Pediatric Formulations Focus Group is the first to report current and global paediatric oral extemporaneous compounding practices. Other reasons for widespread off-label prescribing include the high development cost and complexity in paediatric drug development.
STAT
MAY 22, 2024
A drug often used off-label to treat alcohol use disorder might provide better benefits than therapies approved for this indication, STAT tells us. Australia to ban compounded versions of blockbuster drugs Ozempic and Mounjaro, Reuters reports. If you don’t believe me, just read these items.
Fierce Healthcare
SEPTEMBER 17, 2024
Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers. Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers.
The Checkup by Singlecare
DECEMBER 12, 2024
Ozempic is also sometimes prescribed off-label (for a non-FDA-approved use) as a weight loss drug. With the popularity of glucagon-like peptide 1 receptor agonists ( GLP-1 agonists ) like Ozempic, you may have seen advertisements for compounded semaglutide. That includes compounded semaglutide. This is the case with semaglutide.
STAT
AUGUST 2, 2024
In the face of ongoing shortages of the obesity and diabetes medications known as GLP-1s, patients have resorted to a wide array of sources for the drugs, including medical spas and telehealth sites that prescribe compounded versions of the drugs. One sample also contained signs of potential bacterial contamination during manufacturing.
The Checkup by Singlecare
FEBRUARY 17, 2025
Many people are turning to compounded versions of semaglutide for various reasons, such as costs and shortages of approved medications like Ozempic and Wegovy. While compounding alternatives might seem appealing, they lack the testing and quality control of their approved counterparts. Is compounded semaglutide safe?
The Checkup by Singlecare
FEBRUARY 14, 2025
It is also commonly prescribed off-label (for non-FDA-approved use) to help with weight loss and weight management in people with obesity or who are overweight with weight-related medical conditions. Enter compounding pharmacies , which create compounded versions of drugs like tirzepatide. What is compounded tirzepatide?
European Pharmaceutical Review
OCTOBER 24, 2023
Europe’s pharmaceutical packaging and labelling market is projected to reach $35.78 billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 This is projected to grow at the highest compound annual growth rate of 5.27
The Checkup by Singlecare
FEBRUARY 13, 2025
When this happens, compounding pharmacies (such as those that work with telehealth companies ) are able to make formulations of a drug that is not readily available. Although compounded versions of tirzepatide, the active ingredient in Zepbound, are becoming popular online, the two drugs are not exactly the same.
The Checkup by Singlecare
FEBRUARY 14, 2025
As a result, many people look for cheaper options or ways to skip the shortage wait, which is where compounded GLP-1s come in. Compounded drugs are custom-made versions of brand-name medications that are often easier to get and may cost less. Read on to learn more about the safety of compounded GLP-1s and the risks behind using them.
The Checkup by Singlecare
FEBRUARY 13, 2025
It was approved by the Food and Drug Administration (FDA) in 2022 to help control blood sugar levels in adults with Type 2 diabetes , but healthcare providers often prescribe this medicine off-label (for a non-FDA-approved use) for weight loss in people with obesity (or overweight with certain medical conditions). But are these products safe?
The Checkup by Singlecare
FEBRUARY 13, 2025
With the growing popularity of glucagon-like peptide 1 receptor agonists ( GLP-1 receptor agonists ) like Wegovy, you may have seen advertisements for compounded semaglutide productsbut are these products exactly the same as Wegovy? What is compounded semaglutide?
The Checkup by Singlecare
DECEMBER 12, 2024
Semaglutide has become a very popular drug thats in high demand in pharmacies everywhere and is currently also available from compounding pharmacies and online. But not all compounded semaglutide products are safe. Heres what to know about buying semaglutide from a compounded pharmacy or online. What is compounded semaglutide?
BuzzRx
OCTOBER 14, 2022
If your doctor’s office has given you a prescription with instructions to fill it at a compounding pharmacy, you might be wondering what exactly this means. Only around 7,500 are compounding pharmacies, of which only 3,000 perform sterile compounding. What does it mean when a pharmacy is compounding?
European Pharmaceutical Review
MAY 15, 2024
Research has demonstrated a cost-effective storage solution for compounded faricimab kept for a maximum of 28 days. Authors of the paper stated that it provides off-label use of the anti- vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) biologic , “while maintaining safety in the treatment of patients”.
The Checkup by Singlecare
JANUARY 6, 2025
It is also prescribed off-label for weight loss. Compounded semaglutide is a medication thats custom-made for you by a compounding pharmacy. Though sometimes marketed as a generic version of Ozempic , compounded versions of semaglutide are not FDA approved. RELATED: Is compounded semaglutide safe?
Omnicell
SEPTEMBER 5, 2022
Dennis Wright Senior Director, Central Pharmacy Dispensing Services, Omnicell As disruption and uncertainty in the supply of IV medications from outsourced compounding facilities continues, health system pharmacies should reevaluate how they are managing sterile compounding needs. 23 at 1 pm ET.
IDStewardship
OCTOBER 14, 2024
Read all about this in the product label here. More information on ganciclovir in the label here. Compounding sulbactam-durlobactam Admittedly I have never compounded this one myself, but it just sounds like an error waiting to happen as well as a considerable time commitment. Well, maybe not.
Omnicell
FEBRUARY 17, 2023
Dennis Wright Senior Director, Product Marketing, Omnicell For more than 15 years, IV robotics has proven efficacy in safe and efficient sterile compounding, but market adoption has been limited. Our engineering team scoured through design ideas and broke down all the compounded activities into individual tasks.
Pharmaceutical Technology
MARCH 23, 2023
It is also being assessed in other tumour types and along with other Incyte pipeline compounds. We continue to study the potential of Zynyz in additional tumour types and in combination with other Incyte pipeline compounds.” Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).
STAT
JANUARY 25, 2024
One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. Ozempic and similar diabetes medicines have been increasingly used off label for weight loss.
The Honest Apothecary
APRIL 24, 2023
CALIFORNIA CONSIDERS CLASSIFYING FLAVORING AS “COMPOUNDING “ In a nearly unprecedented move, the state of California is considering treating “flavoring” of a prescription (such as a child’s antibiotic) as “compounding”, thus making the process more difficult and burdensome to pharmacies.
The Checkup by Singlecare
MARCH 25, 2024
Others have just waited or turned to a compounded version of the drug,” Dr. Jordan says. Because those drugs are not FDA approved for weight loss, like Wegovy, healthcare providers may prescribe them off-label. When medications are prescribed off-label, there is a small chance that the patient’s insurance covers the medication.
European Pharmaceutical Review
APRIL 19, 2023
This represents a compound annual growth rate (CAGR) of 15.4 This is driving the adoption of item-level smart labelling , the report noted. A market report has identified that global demand for electronic smart packaging will reach $2.6 billion in 2033. percent from 2023, according to the data.
European Pharmaceutical Review
FEBRUARY 8, 2023
Breyanzi will exhibit the largest compound annual growth rate (CAGR) at 30 percent, compared to Yescarta’s CAGR of 9 percent. Breyanzi is approved for DLBCL, and a label expansion is anticipated for expansions into marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) in 2026 and 2028, respectively. billion in 2031.
The Checkup by Singlecare
NOVEMBER 13, 2024
It’s also commonly prescribed off-label for weight loss. Some people have tried cheaper alternatives like compounded semaglutide, but these options may not always be safe or trustworthy. These are often sold as compounded drugs containing the same active ingredients as brand-name drugs. Is compounded semaglutide safe?
European Pharmaceutical Review
DECEMBER 5, 2022
PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. Pluvicto is an intravenous radioligand therapy that combines a ligand, a targeting compound with lutetium-177, a therapeutic radionuclide.
BioPharm
OCTOBER 27, 2024
The response of tumor cells, such as glioblastomas, to cytotoxic chemotherapeutic compounds is a complex and dynamic process that is crucial to understand in neurooncology research.
Pharmaceutical Technology
OCTOBER 31, 2022
On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.
pharmaphorum
SEPTEMBER 14, 2021
At the moment, SUNHA is generally treated off-label using epilepsy medicines like lamotrigine, topiramate and gabapentin, but there is limited data backing their efficacy. The post First subject dosed in psilocybin trial for rare headache disorder appeared first on.
Hospital Pharmacy Europe
MARCH 21, 2024
Supporting the successful compounding of drugs with 3D printing processes has the potential to not only fulfil unmet patient needs but also drive efficiencies in hospital pharmacies. 1 This manufacturing technology is becoming increasingly important in all production sectors after having been first commercialised in the mid-1980s.
The Checkup by Singlecare
MARCH 10, 2025
The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? affected by a shortage).
The Checkup by Singlecare
APRIL 17, 2024
Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. Mounjaro’s only on-label use is for diabetes, so Medicaid likely won’t cover it for obesity. Look into compounded options (but be careful).
European Pharmaceutical Review
JANUARY 23, 2023
In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding. MSSG and the SPOC working party will continue to closely monitor the situation together with the EC and EU States.
The Checkup by Singlecare
AUGUST 31, 2023
However, some healthcare professionals prescribe Mounjaro off-label for weight loss. You may see compounded versions of generic tirzepatide marketed online or with certain prescribers. Compounded drugs do not have the same FDA regulations and oversight as commercially available products. Everyone will pay the full cash price.
European Pharmaceutical Review
JANUARY 25, 2024
Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. The guidance document also emphasised semipermeable CCSs as another factor to consider in relation to E&Ls.
The FDA Law Blog
DECEMBER 3, 2023
The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. of the total expenditures for all Part D drugs in 2021.
European Pharmaceutical Review
MARCH 13, 2024
The study used medications labelled as “sterile, oral and topical preparations, components of formulations for micro-pellicle media, re-agents, and chemical compounds for achieving selectivity, factors promoting multiplication, and inhibition factors.” aeruginosa bacteria in pure culture, mixed culture, or other research materials.
The Checkup by Singlecare
MARCH 11, 2025
Some healthcare providers might prescribe it off-label for weight management as well. Some compounding pharmacies might make semaglutide tablets themselves, but these drugs arent FDA-approved or inspected. Even though it’s technically an off-label treatment, oral semaglutide is just as effective for weight loss.
Omnicell
JANUARY 10, 2023
Sterile compounding is also one of the costliest functions in pharmacy operations. Still, many hospital pharmacies continue to struggle to improve safety and efficiency in their sterile compounding operations. Insourcing IV compounding services at Moses H. Studies have shown that one out of every ten can put patients at risk.
The Checkup by Singlecare
NOVEMBER 22, 2024
Ozempic (semaglutide) has made its way into headlines and water-cooler conversations largely due to its off-label use for weight loss more than its approved use for Type 2 diabetes mellitus. The high demand status and off-label use may lead to questioning of whether Ozempic is a controlled substance or drug that can be abused.
European Pharmaceutical Review
AUGUST 17, 2022
Radioligand therapy (RLT), which combines a targeting compound (ligand) with a therapeutic radioactive atom (radioisotope), is an emerging treatment approach that may offer an alternative treatment option for some cancer patients. Its licensing makes it the first diagnostic PSMA imaging tracer to receive this status in Great Britain.
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