Pharma

Lisdexamfetamine Dimesylate (not just for ADHD anymore)

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Llisdexamfetamine dimesylate is currently the only drug to be approved in the USA for the treatment of moderate to severe binge eating disorder (BED) in adult patients. – https://pubmed.ncbi.nlm.nih.gov/29134566/

Just a few side effects BTW.

The prescribing information also includes warnings and precautions regarding serious cardiovascular reactions, blood pressure and heart rate increases, psychiatric adverse reactions, suppression of growth, peripheral vasculopathy (reduced circulation of blood flow to body parts), and serotonin syndrome (a potentially life-threatening overage of serotonin). Please see Vyvanse’s full prescribing information for additional details.

The most common side effects in children, adolescents and/or adults with ADHD taking lisdexamfetamine dimesylate capsules and chewable tablets were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. The most common side effects in adults with BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment

Take Home Lesson for Life Underwriters

Know your drugs and read the prescription DB reports. You’re welcome.

Compounding Compounds the Problem

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Compound pharmacies that bulk produce weight-loss drugs without FDA approval are doing so without that oversight.  And because compounding pharmacies aren’t required to report instances of patient harm involving their medications, problems may go undetected.“It’s kind of like ‘Whack-A-Mole,’” said Al Carter, a pharmacist and executive director at the National Association of Boards of Pharmacy. He said state boards will only investigate when they receive a complaint.“There are bad actors out there, purporting to be compounding pharmacies that are licensed in specific states or have the credentials to be able to compound when in actuality they don’t,” said Carter. “My understanding is most licensed, legitimate pharmacies aren’t compounding” weight-loss medications. ‘Compounded’ weight-loss drugs are a growing problem for state regulators – https://stateline.org/2024/07/08/compounded-weight-loss-drugs-are-a-growing-problem-for-state-regulators/

A website sold patients obesity drugs at affordable rates. Now they’re paying the price.– https://www.npr.org/2025/02/08/nx-s1-5246124/a-website-sold-patients-obesity-drugs-at-affordable-rates-now-theyre-paying-the-price

“The two main goals of the medication are weight loss and diabetes management, so patients should stay on the lowest dosage possible until they feel like they’ve plateaued,” said Charu Sawhney, DO, MPH, an internal medicine physician with Harbor Health in Round Rock, Texas. When patients move up on the dosage too fast, they’re going to have more trouble, said Sawhney. “This is when we see the most severe side effects like the malnutrition and dehydration that can sometimes land patients in the hospital,” she said. Considerations for Prescribing GLP-1s Get More Complicated – Medscape – February 07, 2025 – https://www.medscape.com/viewarticle/considerations-prescribing-glp-1s-get-more-complicated

I admit as a Former Fat Man that the world of obesity and now a miracle drug to fight the disease fascinates the hell out of me. Caveat emptor!

Ugh… Kids These Days!

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While cocaine was once the drug of choice, bankers are now reportedly turning to the ADHD medication for work days that can last as long as 22 hours, along with nicotine patches and energy drinks. 90-hour-a-week Wall Street bankers snorting lines of Adderall at their desks – https://www.telegraph.co.uk/world-news/2024/12/15/90-hour-a-week-wall-street-bankers-snorting-adderall-desks/

It never ceases to amaze this Old Underwriter how people manage to find creative ways to kill themselves.

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.

Telehealth Company Cerebral Agrees to pay $3.7M fine (and found guilty of nothing)

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Telehealth company Cerebral has agreed to pay a fine of more than $3.6 million for allegedly attempting to boost prescriptions of Adderall and other controlled substances, the Department of Justice and Drug Enforcement Administration said Monday. 

Regulators allege Cerebral’s initial visit metric didn’t consider medical literature or whether prescriptions would be clinically appropriate for patients. The company also used financial incentives to spur providers to meet prescribing metrics — and even considered disciplinary measures for those who hadn’t prescribed enough stimulants for ADHD patients, according to a press release.

https://www.healthcaredive.com/news/cerebral-controlled-substance-prescribing-fine-doj-dea/732108/

This company agreed to a fine it was unable to pay so the regulators deferred payment.

Huh?

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/

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Metformin and Aging (great news if you’re a monkey)

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Metformin has been used for more than 60 years to lower blood-sugar levels in people with type 2 diabetes — and is the second most-prescribed medication in the United States. The drug has long been known to have effects beyond treating diabetes, leading researchers to study it against conditions such as cancer, cardiovascular disease and ageing…

The researchers observed that the drug slowed the biological ageing of many tissues, including from the lung, kidney, liver, skin and the brain’s frontal lobe. They also found that it curbed chronic inflammation, a key hallmark of ageing. The study was not intended to see whether the drug extended the animals’ lifespans; previous research has not established an impact on lifespan2 but has shown lengthened healthspan3 — the number of years an organism lives in good health. The brain aged more slowly in monkeys given a cheap diabetes drug https://www.nature.com/articles/d41586-024-02938-w

Small sample size, just 12 monkeys.