Drugmaker Shut Down After Black Schmutz Found in Injectable Weight-Loss Drug
Freeman writes:
The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile-particularly injectable drugs-without using sterile ingredients or any sterilization steps.
The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide [...] tirzepatide
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The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from Fullerton Wellness had an unidentified "black particulate" floating in it. Semaglutide, like tirzepatide, is injected under the skin and is intended to be sterile.Injecting a "non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis," the FDA warned.
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This is just the latest warning on weight-loss drugs from the FDA, which has repeatedly cautioned about quality and safety problems related to compounded versions of the drugs. The compounded drugs are intended to be essentially copycat versions of the blockbuster brand-name drugs. Compounding pharmacies can make copycat versions only as long as the drugs are in short supply, acting as a stopgap for patient access. But, with the popularity of the drugs and the high prices of the brand-name versions, compounded formulations have become seen as affordable alternatives for many patients.
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Also in October, Novo Nordisk asked the FDA to stop letting compounders make copycat versions of semaglutide, arguing that the drug is too complex for compounders to make and poses too many safety risks to patients. In response, the trade organization for compounders, the Outsourcing Facilities Association, submitted a letter to the FDA asking it to require Novo Nordisk to provide an economic impact statement to assess the cost and price increases that could occur if semaglutide were no longer available through compounding pharmacies.
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