Drugs

Mind the Gaps – Update 11.10.24

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More good news since I posted Mind The Gaps.

On November 5, the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about pulmonary aspiration during general anesthesia or deep sedation. The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). FDA Updates GLP-1 Label With Pulmonary Aspiration Warning – Medscape – November 06, 2024. https://www.medscape.com/viewarticle/fda-updates-glp-1-label-pulmonary-aspiration-warning-2024a1000k84?src=rss

Interesting potential side effect. This is from the FDA on regulated GLP-1 RA drugs. But since I know a lot of you out there are using the compounded version…

https://www.medscape.com/s/viewarticle/novo-nordisk-aware-10-deaths-compounded-weight-loss-drug-2024a1000k8f?src=rss

Death is also a potential side effect of the FDA regulated version.

Susan McGowan, 58, took two low-dose injections of tirzepatide, known under the brand name Mounjaro, over the course of about two weeks before her death on 4 September.Her death certificate, seen by the BBC, lists multiple organ failure, septic shock and pancreatitis as the immediate cause of death – but “the use of prescribed tirzepatide” is also recorded as a contributing factor…There have been 23 suspected deaths linked to semaglutide in the UK via the yellow card scheme since 2019. Nurse’s death linked to approved weight-loss drug – https://www.bbc.com/news/articles/cz6jg6nw2zeo?

Yikes.

Mind The Gaps

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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, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro. Drugmaker shut down after black schmutz found in injectable weight-loss drug — https://arstechnica.com/health/2024/11/drugmaker-shut-down-after-black-schmutz-found-in-injectable-weight-loss-drug/

I’ve read the FDA advisory. The FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness — https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-compounded-drugs-fullerton-wellness

  1. If you’re injecting what you believe is a weight loss medication do you pay any attention to who the manufacturer is?
  2. Do you read any of the FDA drug alerts and statements?
  3. The FDA names the compounding facility but does not name of any clinics or online purveyors who may be selling you tainted and non-sterile drugs.
  4. If you ask your online provider questions will you get honest answers?
  5. Is losing a few pounds worth the risk?
  6. Have you considered the possibility that the side effects you’re having are not just normal side effects from a GLP-1 type compounded drug and may be from an impure product?

Yikes.