{"id":390056,"date":"2026-04-13T16:19:08","date_gmt":"2026-04-13T16:19:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/390056\/"},"modified":"2026-04-13T16:19:08","modified_gmt":"2026-04-13T16:19:08","slug":"compounded-glp-1-drugs-may-be-risky-for-patients","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/390056\/","title":{"rendered":"Compounded GLP-1 drugs may be risky for patients"},"content":{"rendered":"

(NewsNation<\/a>) \u2014 Getting Ozempic<\/a> seems to be getting easier not only for patients, but for companies as well.<\/p>\n

Compounding companies are creating versions of the drug by sourcing the active ingredient from FDA-registered suppliers when brand-name drugs are on the FDA shortage list. <\/p>\n

These pharmacies<\/a> mix the raw compound, often altering it into a salt formulation rather than the specific, patented formulation used in the branded auto-injector pens.<\/p>\n

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\u201cCompounding pharmacies exist to help patients whose needs aren\u2019t met by existing approved drugs,\u201d notes<\/a> NPR\u2019s Sydney Lupkin. \u201cThe compounded drugs are not generics, nor do they go through the Food and Drug Administration\u2019s approval process.\u201d<\/p>\n

How do companies gain access to Ozempic to make compounded drugs?<\/p>\n

Companies that make compounded drugs obtain semaglutide API from authorized and registered chemical manufacturers.<\/p>\n

They\u2019ve done it by taking advantage of the short supply of the brand-name medications that started four years ago.<\/p>\n

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The FDA says<\/a> \u201cit does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month.\u201d<\/p>\n

What are the FDA concerns about compounded drugs?<\/p>\n

While the FDA doesn\u2019t review<\/a> compounded drugs, the agency still wants the medicine to have the identical ingredients as the commercially available products.<\/p>\n

What that means is the product is similar or contains easily substitutable strength, while the commercially available drug product can be used by the same route of administration prescribed for the compounded drug product.<\/p>\n

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\u201cAs with all compounded drugs, drugs compounded by outsourcing facilities have not undergone FDA premarket review for safety, effectiveness, and quality, and lack a premarket inspection and finding of manufacturing quality that is part of the drug approval process,\u201d the agency acknowledges. <\/p>\n

\u201cBecause they are subject to a lower regulatory standard, compounded drugs should only be distributed to health care facilities or dispensed to patients to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.\u201d<\/p>\n

What health effects come from compounded drugs?<\/p>\n

Experts say compounded semaglutide may cause many of the same\u00a0side effects\u00a0as Ozempic and Wegovy. But taking them with the lack of FDA oversight exposes<\/a> patients to serious safety and efficacy risks.<\/p>\n

\u201cI don\u2019t recommend using compounded versions of these medications because they\u2019re untested \u2014 both in their effectiveness and their safety,\u201d said<\/a> Dr. W. Scott Butsch, the Director of Obesity Medicine in the Bariatric and Metabolic Institute at the Cleveland Clinic.<\/p>\n

This drug\u2019s lack of standardization increases the risk of miscalculation or unintentionally drawing up an inappropriate dose. Adverse events from people taking the compounded drugs have also included<\/a> hospitalizations. <\/p>\n

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GoodRx states<\/a> patients may also be subject to potential contamination, impurities and dosage errors.<\/p>\n

\u201cOne study found that about 45% of drug recalls over a roughly 10-year period were from compounding pharmacies,\u201d the health website said. \u201cThese recalls were mostly due to sterility concerns.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"(NewsNation) \u2014 Getting Ozempic seems to be getting easier not only for patients, but for companies as well.…\n","protected":false},"author":2,"featured_media":390057,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[5800,163,85,46,482],"class_list":["post-390056","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-author","tag-health","tag-il","tag-israel","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/390056","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=390056"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/390056\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/390057"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=390056"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=390056"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=390056"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}