Topline
The manufacturer of Ozempic and Wegovy has announced it will take legal action against facilities illegally compounding the drugs amid ongoing shortages, leaving some patients without medication.
Don’t mess with Mr. In-Between: good advice then, good advice now.
Main facts
Novo Nordisk, the creator of Ozempic, Wegovy, and Rybelsus (generic name: semaglutide), announced On Tuesday, it filed a lawsuit against some weight-loss or wellness clinics, medical spas and compounding pharmacies to block the sale of compounded versions of their drugs.
Compound involves combining or altering drugs or ingredients to make a drug designed for a specific patient – in the case of counterfeit Ozempic and Wegovy, the dangerous salt form of semaglutide is used in the injectables, which differs from the approved version of the medicine.
Both Ozempic and Wegovy have been on the Food and Drug Administration’s drug shortage list for months after a rise in popularity for their weight loss benefits.
The FDA issued one itself warning on compounded semaglutide in May, stating it has received reports of “side effects” after using compounded versions of the drug, and warned that patients should not use compounded drugs if an approved drug is available.
The FDA also advised patients to proceed with caution, as some of the compound semaglutide may not contain the same active ingredients as the approved version and may contain salt formulations, which are neither safe nor effective.
Compound drugs are not FDA approved or regulated, so the agency is not capable of to verify the safety of the medication and they also do not have manufacturing quality approval.
Key background
The FDA reported rather, it has witnessed “disturbing conditions” in some compounding facilities, including pet beds near sterile compounding areas, the use of toaster ovens for sterilization, and people handling sterile drugs without skin protection, which can lead to the potential spread of bacteria. Poor manufacturing practices can cause serious drug quality problems, such as contamination or a drug with too much of an active ingredient. A 2013 study published in Drug R&D compounded sterile preparations found may carry the risk of microbial contamination. Over the course of 11 years, the study reports that three separate cases of meningitis outbreaks were linked to “sterile” steroid injections contaminated with bacteria or fungi made by compounding pharmacies. The US suffered the most brutal outbreak with contaminated compound drugs in 2012, when a Massachusetts pharmacy shipped mold-contaminated drugs across the country. These drugs were injected into patients’ spines and joints, causing more than 750 people in 20 states to develop yeast infections, including 60 related deaths. More than 14,000 patients received injections of this batch of contaminated drugs.
contra
The drug preparation process has been used as a remedy for drug shortages for decades. When the asthma drug albuterol first ran into a shortage earlier this year, hospitals formulated the drug to tailor it to each patient. Compound medications are needed if an FDA-approved drug is not available, if a patient needs a modified dosage, or is allergic to a particular dye and needs the medication to make do without, according to to the Congressional Research Service. However, according to according to the FDA, this should only be done by physicians in hospitals, clinics, and other healthcare facilities.
Read further
What you need to know about Ozempic: The diabetes drug becomes a viral hit for weight loss (Elon Musk claims he uses it) Creating a deficit (Forbes)
Wegovy Shortage: Drugmaker Limits Distribution—Here’s When Stocks Should Improve (Forbes)
‘Ozempic Face’ explained: why it happens and how to fix it (Forbes)
Asthma Drug Albuterol Deficiency Threatens To Worse: Here’s Why — And How Hospitals Are Filling The Gaps (Forbes)
Ozempic as a pill: drugmakers race for cheaper weight loss drugs (without the injections) (Forbes)