pharmaceutical

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.

FDA Announces Recall for Duloxetine

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Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.FDA Announces Recall of More than 7000 Bottles of Duloxetine – Medscape – October 28, 2024. – https://www.medscape.com/viewarticle/fda-announces-recall-more-than-7000-bottles-duloxetine

Depressing. But will be very depressing for people on this medication.

The More Drugs You Take…(fill in the blank)

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This was a retrospective longitudinal cohort study of adults aged 60 years and older.

An increase in polypharmacy severity was significantly associated with a higher likelihood of all-cause hospitalization within 1 year, but not a hospitalization related to IBD. Use of a PIM (potentially inappropriate medication) was also associated with a higher probability of all-cause hospitalization compared with patients without. Hospitalization Risk in Older Adults With IBD Associated With Severe Polypharmacyhttps://www.gastroenterologyadvisor.com/news/hospitalization-risk-in-older-adults-with-ibd-associated-with-severe-polypharmacy/

Photo by Anna Shvets on Pexels.com

Statins Raise Diabetes Risk (but CV Benefit Outweighs the Risk)

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Statins raise the risks for increased glucose levels and the development of type 2 diabetes among people who don’t have it at baseline, but those risks are outweighed by the cardiovascular benefit, new data suggested.

The meta-analysis of trials in the CTT Collaboration included individual participant data from 19 double-blind randomized, controlled trials with a median follow-up of 4.3 years comparing statins with placebo in a total of 123,940 participants, including 18% who had known type 2 diabetes at randomization. Also analyzed were another four double-blind trials of lower- vs higher-intensity statins involving a total of 30,724 participants followed for a median of 4.9 years, with 15% having diabetes at baseline.

In the 19 trials of low- or moderate-intensity statins vs placebo, statins resulted in a significant 10% increase in new-onset diabetes compared with placebo (rate ratio, 1.10), while high-intensity statins raised the risk by an also significant 36% (1.36). This translated to a mean absolute excess of 0.12% per year of treatment.

Compared with less intensive statin therapy, more intensive statin therapy resulted in a significant 10% proportional increase in new-onset diabetes (1.10), giving an absolute annual excess of 0.22%

In an accompanying editorial, Hertzel C. Gerstein, MD, and Marie Pigeyre, MD, PhD, both of McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada, noted that the decreased absolute annual incidence of life-threatening cardiovascular outcomes with statins in people at high risk for type 2 diabetes “clearly exceeds the 0.1%-1.3% per year increased absolute incidence of type 2 diabetes.”

Statins Raise Diabetes Risk, but CV Benefit Outweighs It – Medscape – April 09, 2024. — https://www.medscape.com/viewarticle/statins-raise-diabetes-risk-cv-benefit-outweighs-it

ATTENTION PARENTS – Social Media and Self-Diagnosis (scary charts too)

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Image source – Technology and Student Well-Being: 10 Charts https://www.edweek.org/research-center/reports/technology-and-student-well-being-10-charts

In The Anxious Generation: How the Great Rewiring of Childhood Is Causing an Epidemic of Mental Illness, social psychologist and author Jonathan Haidt lays out his argument that smartphones and social media are the key driver of the decline in youth mental health seen in many countries since the early 2010s.

The early 2010s were crucial, Haidt argues, because that was when smartphones really began to transform childhood into something unrecognizable. In June 2010, Apple introduced its first front-facing camera, and a few months later Instagram launched on the App Store. For Haidt, this was a fateful combination. Children were suddenly always online, always on display, and connected in ways that were often detrimental to their well-being. The result was a “tidal wave” of anxiety, depression, and self-harm, mostly affecting young girls.In Haidt’s telling, though, smartphones are only part of the problem. He thinks that children in the West are prevented from developing healthily thanks to a culture of “safetyism” that keeps children indoors, shelters them from risks, and replaces rough-and-tumble free play with adult-directed organized sports or—even worse—video games. For evidence of safetyism in action, Haidt contrasts a picture of a 1970s playground merry-go-round, (“the greatest piece of playground equipment ever invented”) with a modern set of play equipment designed with safety in mind and, thus, giving children less opportunity to learn from risky play.

Screen Time for Kids Is Fine! Unless It’s Not — https://www.wired.com/story/pete-etchells-jonathan-haidt-smartphones/?utm_source=pocket_saves

Next steps? Go back online, find a venture capital backed mental health provider, take a quiz, get a diagnosis that confirms your self-diagnosis, have drugs sent to you in the mail.

The scourge of self-diagnosis.

Trends in Behavioral Health Medications

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Nurse Practitioners and Behavioral Health Medications Prescriptions

Nurse practitioners had the largest increases in prescribing incident prescriptions across the 5 drug classes. This is consistent with a study that found that behavioral health visits among Medicare beneficiaries conducted by psychiatric behavioral health nurse practitioners increased by 162%, whereas those by psychiatrists decreased by 6% from 2011 to 2019.35 Our study, based on incident prescription data, suggests an increasing contribution of nurse practitioners initiating medication treatment of behavioral health conditions compared with other health care practitioners.

Chai G, Xu J, Goyal S, et al. Trends in Incident Prescriptions for Behavioral Health Medications in the US, 2018-2022. JAMA Psychiatry. Published online January 10, 2024. doi:10.1001/jamapsychiatry.2023.5045 — https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2813980

Welcome to our new world of self-diagnosed ADHD, online pill mills, and “shortages” of prescription medications.

The past couple of decades have seen a continuous increase in attention deficit hyperactivity disorder (ADHD) diagnoses. National population surveys reflect an increase in the prevalence from 6.1% to 10.2% in the 20-year period from 1997 to 2016 and experts continue to debate and disagree on the causes for this trend.1

ADHD Diagnostic Trends: Increased Recognition or Overdiagnosis? Mo Med. 2022 Sep-Oct; 119(5): 467–473.– https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9616454/

Too Old To Grow Up?

Percentage change in the leading health conditions affecting millennials in the United States from 2014 to 2018 — https://www.statista.com/statistics/1276447/percentage-change-of-the-leading-conditions-affecting-millennials

I was doing my usual Saturday morning routine, catching up on whatever was catching my attention and I came across this Scary Chart looking for ADHD incidence in Millennials. Whoa…check out the early CAD percentage increase.

Complications? What Complications? (just another GLP-1 receptor agonist post)

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Adverse events are common in those using GLP-1 agonists, but the vast majority of these are minor. GI adverse effects are most common (20-70% of patients). Greater rate of GI effects with higher doses.

  • Most common problems: nausea (overall most common), vomiting, and diarrhea. Others included abdominal pain, dyspepsia, and constipation.
  • Symptoms are typically more severe within the first four weeks of therapy or with sudden escalation of therapy and tend to decrease over time.
  • Thought to be due to reduced gastric emptying and activation of centers involved in appetite regulation and nausea.
  • Severe diarrhea and vomiting may lead to volume loss, dehydration, and hypotension (not common).
  • There is an association with pancreatitis. GLP-1 agonists may stimulate pancreatic islet beta cells and exocrine duct cells leading to overgrowth and smaller duct size, which increase the pancreatic weight and risk of ductal occlusion.
    • Retrospective study published in 2022 of 81,752 adverse events associated with GLP-1 agonist therapy found an increased risk of pancreatitis, particularly with liraglutide (ROR 32.67; 95% CI 29.44-36.25). 2023 observational study found increased risk of pancreatitis (adjusted HR of 9.09, 95% CI 1.25-66).
  • Other GI issues include gallbladder and biliary tract disease (usually after 26 weeks of therapy and included cholelithiasis, cholecystitis, cholangitis), elevated LFTs, hepatitis, liver injury.
emDOCs Podcast – Episode 94: GLP-1 Agonist Complications — https://www.emdocs.net/?s=glp-1

But I Lost 25 pounds!

New Wonder Drug! Treat Diabetes, Obesity AND Addiction – (yup another GLP-1 receptor agonist post)

Why People Stop Using Drugs Like Ozempic – Wired (yet another GLP-1 receptor agonist post)

What the Scientists Who Pioneered Weight-Loss Drugs Want You to Know – Wired Magazine