OOPS: Ozempic Maker’s Factory Fails FDA Inspection — What Does That Mean For Consumers?
Was the new diabetes/weight-loss drug a victim of its own success?
The sudden popularization of Ozempic’s off-label uses created a demand that was difficult for the manufacturer to keep up with.
Ozempic was developed as a medication to help diabetics maintain their sugar levels. But it wasn’t long before our diet-crazed culture caught on that it was a shortcut to weight loss results that didn’t require radical changes to a patient’s diet. There are a number of reasons you would want to think twice before doing so, and obviously, we don’t recommend any medication without a doctor’s advice.
But this ‘hack’ became popular enough to change consumer behavior and drive pharmacy sales.
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Both Ozempic and Wegovy have semaglutide as their key active ingredient, even if their dosage and usage differs.
One of the factories where both medications are made has just failed an FDA inspection.
An Ozempic and Wegovy factory in North Carolina that helps serve millions of Americans has failed an inspection, reports suggest.
The factory was found to have ‘objectionable’ conditions by the Food and Drug Administration (FDA).
Based in Clayton, North Carolina, the drug manufacturer now has three weeks to devise an action plan to rectify the issues or risk facing further action. Novo Nordisk, which owns the factory, says manufacturing is ‘ongoing’.
The Danish company behind the blockbuster weight-loss drugs Ozempic and Wegovy has been rapidly expanding its manufacturing capacity to meet soaring demand — with five million prescriptions for its weight loss medications written in the US last year alone.
This surge led to major shortages of the drugs earlier this year, prompting pharmacies to mix their own versions.
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Objectionable conditions listed on Form 483 include dirty or damaged equipment, failure to properly store medications and insufficient paperwork. The reason Novo Nordisk was issued the form has not been made public. — DailyMail
Shares dropped briefly on the news, but have since rallied to some degree.
Contrary to what fear-mongers scolding us about a certain so-called horse-dewormer during the COVID years might have us believe, off-label uses of medication are fairly common.
The most famous example is probably Viagra, which was originally created for cardiovascular problems had a very noteworthy side-effect and it wasn’t long before this ‘secondary’ use of the medication far outpaced the original intent.
