FDA

Mind The Gaps

/ SupremeCmdr / Leave a comment

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

/ SupremeCmdr / Leave a comment

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.

SARMs (Selective Androgen Receptor Modulators)

/ SupremeCmdr / Leave a comment

SARMs, which are chemical substances that mimic the effects of testosterone and anabolic steroids, are not FDA approved. Online vendors and social media influencers are using social media to make SARMs seem safe and effective.

The reality is SARMs are potentially dangerous. The FDA continues to receive adverse event reports associated with SARMS use. The real number of consumers experiencing adverse events is likely higher due to underreporting.  Because these are not approved drugs, consumers may be reluctant to report adverse events or may not be aware that they can report adverse events that they experience. In addition, they might not know that their symptoms are being caused by the product.

Studies and reports show SARMs are associated with serious or life-threatening health problems, such as:

  • Increased risk of heart attack or stroke
  • Psychosis/hallucinations    
  • Sleep disturbances
  • Sexual dysfunction 
  • Liver injury and acute liver failure 
  • Infertility
  • Pregnancy miscarriage
  • Testicular shrinkage 
FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults — https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults

If you’ve read this far, congratulations. Now spread the word.

FDA Approves First Over-the-Counter Naloxone Nasal Spray (Scary News or What?)

/ SupremeCmdr / 5 Comments

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.

FDA Approves First Over-the-Counter Naloxone Nasal Spray — https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

FDA Approval – SalivaDirect

/ SupremeCmdr / Leave a comment

The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity.

The new test, which is called SalivaDirect and was developed by researchers at the Yale School of Public Health, allows saliva samples to be collected in any sterile container. It is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. The test also avoids a key step that has caused shortages of chemical reagents used in other tests.

The research team validated SalivaDirect in part by testing NBA players, coaches, and staff, and Yale said the test is now being studied in asymptomatic people through the program with the NBA and its players union.

FDA clears saliva test for Covid-19, opening door to wider testing

Get tested and wear a mask.

EfVgeCLWsAQSVXt

To understand why this is a potential game changer this article on rapid screening tests.

First, frequent testing catches the vast majority of cases. Someone who is infected but gets a false-negative and slips through the cracks is likely to be caught the next time they’re tested. For a test that misses 20% of positive cases, the chance of an infected person getting two false negatives in a row may be as low as 4%. It’s like bailing a boat with a leaky bucket: You just have to bail more quickly to get the job done.

Second, most people who get false-negative results are unlikely to be contagious. Antigen-based screening tests are good at detecting the high virus levels needed to be contagious. By design, screening tests sacrifice accuracy where it matters least to achieve low costs, speed and ease of use.

AND I learned that the SalivaDirect test was funded by the NBA.

“My goal is not to test athletes,” Grubaugh said. “That’s not my target population. My target population is everybody. There were concerns about partnering with the NBA when all these other people need testing. But the simple answer ended up being the NBA was going to do all this testing anyway, so why not partner with them and try to create something for everyone?”

The NBA, Yale and the players’ association do not intend to take royalties from any use of the testing method, Grubaugh and others said. The NBA and union contributed more than $500,000 combined to fund the Yale work, sources told ESPN.

Saliva-based coronavirus test funded by NBA, NBPA gets emergency authorization from FDA

FDA Adds New Warnings to All Testosterone Product Labels

/ SupremeCmdr / Leave a comment

Testosterone and other AAS, which have a schedule III classification by the Controlled Substances Act, may be abused by adults and adolescents, including athletes and body builders.

“Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system,” the FDA notes.

Reported serious adverse outcomes include myocardial infarction, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. People abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia, the agency says.

Source: FDA Adds New Warnings to All Testosterone Product Labels

Source: Safety Alerts for Human Medical Products > Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement – Risks Associated With Abuse and Dependence

It is interesting you no longer see those Low-T commercials on television any more.  Really?  Just another clever marketing campaign to create a disease that doesn’t exist along with a convenient drug based solution.  What side effects?

Read this book.  Now.

Source: Bill Moyers Journal . Profile . Melody Petersen | PBS

FDA Approves Bupropion/Naltrexone Contrave for Obesity

/ SupremeCmdr / Leave a comment

FDA Approves Bupropion/Naltrexone Contrave for Obesity.

If I’m understanding this correctly we now have an anti-depressant combined with a drug originally approved for treating opioid, then alcohol addiction, approved by the FDA to treat obesity.

This will be interesting.

UPDATE

Obesity drugs have side effects. The reason it’s taken three years for the FDA to approve NB32/Contrave is that obesity drugs have serious side effects. So serious, in fact, that several major diet drugs have been yanked from the market, making doctors, regulators and yes, investors shy away. Cardiovascular disease and mood problems are just two of the potentially serious side effects associated with Qsymia and Belviq. Older drugs Xenical  and Alli carry a risk of permanent liver and kidney damage.  And those weight loss supplements you buy over the counter? Some are deadly.

via Contrave: Is This The Weight Loss Drug We’ve Been Waiting For?.

Like I said, this will be interesting.

Safety Alerts – Pradaxa dabigatran – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

/ SupremeCmdr / Leave a comment

Safety Alerts for Human Medical Products > Pradaxa dabigatran: Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin.

ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.