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Sunday, November 12, 2023
Safety Alert - FDA Warns Consumers Not to Purchase or Use Due to Risk of Eye Infection
Sunday, November 5, 2023
Health Beneftis of Fiber in your diet
- The Health Benefits of Dietary Fibers Vary
- Fiber In Diet Linked to Cancer Immunotherapy Response
- Eating Highly Processed Foods Linked to Weight Gain
- Dietary Fiber Protects Obese Mice from Arthritis
- How Dietary Factors Influence Disease Risk
- Rough Up Your Diet: Fit More Fiber into Your Day
- Keeping Your Gut in Check: Healthy Options to Stay on Tract
- Your Digestive System & How It Works
- Questions and Answers on Dietary Fiber (FDA)
Immune response to eating chitin linked to better health
At a Glance
- Eating a type of dietary fiber called chitin evoked an immune response in mice that was linked to better metabolic health.
- The findings suggest a potential therapeutic target for obesity and other metabolic diseases.
Dietary fiber reduces the risk of metabolic disorders such as obesity. Chitin is a common type of fiber found in fungi and the exoskeletons of insects and crustaceans. It can trigger an immune response akin to an allergic reaction. Unlike most dietary fibers, chitin can be digested by mammals. But the mechanism by which this happens is unclear.
An NIH-funded research team, led by Dr. Steven Van Dyken at Washington University in St. Louis, examined how the immune and digestive systems of mice respond to eating chitin. Their findings appeared in Science on September 8, 2023.
Feeding mice a diet containing chitin caused their stomachs to expand. This triggered an immune response in the stomach and small intestine. Certain immune cells proliferated, and the signaling molecules produced by these cells increased. Similar immune cell and signaling responses also occurred in fat tissue. Of note, chitin induced these same responses in germ-free mice, which lacked gut microbes. This shows that the immune responses to dietary chitin didn’t depend on these microbes.
Chitin digestion required an enzyme called acidic mammalian chitinase (AMCase). This enzyme is made by cells in the stomach called chief cells. The researchers found AMCase activity in the stomachs of chitin-fed mice. Mice that lacked this enzyme could not digest chitin. Furthermore, production of AMCase required the immune response that chitin consumption triggered. This suggests that one role of the immune response to chitin is to boost AMCase production. This, in turn, aids in chitin digestion.
To test the metabolic effects of eating chitin, the researchers fed mice high-fat diets that contained either chitin or another fiber. In addition, some of the mice lacked the ability to produce AMCase, so they couldn’t break down chitin. All the mice ate similar amounts. However, chitin-fed mice had better insulin sensitivity than those fed the other fiber. Those who ate chitin but couldn’t break it down had the strongest immune response, gained the least weight, and had the least body fat.
These findings suggest that the immune response to chitin has benefits for metabolic health. This may be because the chief cells that produce AMCase also produce other digestive enzymes. The immune response to chitin may increase production of these as well to improve overall digestion. This process could be a potential therapeutic target for obesity or other metabolic diseases.
“Obesity is an epidemic,” Van Dyken says. “What we put into our bodies has a profound effect on our physiology and on how we metabolize food. We're investigating ways to counteract obesity based on what we learn about how the immune system is engaged by diet.”
What if your child says "I am gay ?
Despite LGBTQ becoming more acceptable as modern science has realized this is not a mental illness there remain many people who chose not to accept this. Some religions cling to the belief it is a 'mortal sin' due to passages in the bible regarding LGBTQ. However, the pendulum is still swinging in that regard. In Western religions it is becoming acceptable, however, in Islam it is still a condition deserving of a death sentence.
When I was in medical school (1964-1968) I was taught it was a mental disorder and even had a DSM category
The psychodynamics of homosexuality, like any other sexual orientation, has been a subject of study and debate in psychology and related fields. It's important to approach this subject with sensitivity and respect for the diverse experiences of individuals.
Portions of the following were written by generative AI (ChatGPT). and as such may not be totally accurate. The content has been reviewed to rule out hallucinations.
1. **Sexual Orientation as a Natural Variation:** The prevailing consensus among mental health professionals and researchers is that homosexuality is a natural variation of human sexuality. It is not a mental disorder, nor is it a choice. People do not choose their sexual orientation; it is a fundamental aspect of who they are.
2. **Biological Factors:** There is evidence to suggest that biological factors, including genetics and prenatal hormonal influences, may play a role in determining a person's sexual orientation. However, these factors are not the sole determinants and research in this area is ongoing.
3. **Psychological Factors:** While homosexuality itself is not considered a psychological disorder, the experience of coming to terms with one's sexual orientation can have psychological implications. Individuals may face stigma, discrimination, and mental health challenges related to societal attitudes and family dynamics.
4. **Social and Cultural Factors:** Society's attitudes and cultural norms can have a significant impact on the psychological well-being of individuals who identify as homosexual. Acceptance and support from family, friends, and society at large can positively influence mental health outcomes.
5. **Intersectionality:** It's crucial to recognize that the experience of being LGBTQ+ intersects with other aspects of a person's identity, such as race, ethnicity, gender, and socioeconomic status. These intersecting factors can influence the psycho-dynamics of homosexuality in unique ways.
6. **Mental Health and Well-being:** LGBTQ+ individuals may face higher rates of mental health challenges, such as depression and anxiety, due to experiences of discrimination and social stigma. It is important to provide mental health support and create inclusive environments to promote well-being.
7. **Identity Development:** Like anyone else, individuals who identify as homosexual go through a process of identity development. This process can involve self-discovery, self-acceptance, and, in some cases, challenges related to family and social acceptance.
In summary, the psychodynamics of homosexuality encompass a range of biological, psychological, social, and cultural factors. It's essential to approach this topic with empathy, respect, and an understanding of the diversity of experiences within the LGBTQ+ community. Promoting acceptance, inclusivity, and mental health support is critical to the well-being of individuals who identify as homosexual or as part of the broader LGBTQ+ spectrum.
8. **Coming Out:** Coming out is a crucial aspect of the psychodynamics of homosexuality. It is the process by which individuals disclose their sexual orientation to others. This can be a highly emotional and challenging experience, as it often involves navigating fear of rejection, discrimination, and the potential impact on personal relationships.
9. **Family Dynamics:** Family reactions to a child or family member coming out as homosexual can vary significantly. Some families are accepting and supportive, while others may struggle to come to terms with it. Understanding and addressing family dynamics is an important part of psycho dynamics, as family acceptance can greatly impact an individual's mental well-being.
10. **Identity Formation:** For many people, their sexual orientation is a central aspect of their identity. Understanding and embracing one's sexual identity is a lifelong process, and it can involve exploring one's values, beliefs, and sense of self in the context of their sexual orientation.
11. **Intersection of Religion and Sexuality:** The intersection of religious beliefs and sexual orientation can be a source of conflict for some individuals. Many religions have varying stances on homosexuality, which can lead to internal and external conflicts as individuals reconcile their faith with their sexual orientation.
12. **Social Support:** The availability of social support systems, such as LGBTQ+ communities, support groups, and affirming friends, plays a significant role in the well-being of homosexual individuals. These networks provide a sense of belonging and validation, which can counteract the negative effects of discrimination and social stigma.
13. **Mental Health Disparities:** Research has shown that LGBTQ+ individuals, including those who identify as homosexual, are at a higher risk of mental health challenges, including depression, anxiety, and substance abuse. These disparities are often linked to the stressors related to societal discrimination and prejudice.
14. **Advocacy and Activism:** Many individuals who identify as homosexual become advocates and activists for LGBTQ+ rights and acceptance. This involvement can be a powerful way to channel personal experiences into creating positive change in society.
15. **Legal and Political Factors:** The legal and political landscape surrounding homosexuality varies widely around the world. In some countries, homosexuality is criminalized, while in others, it is fully accepted and protected by anti-discrimination laws. These factors can significantly influence the psycho dynamics of homosexuality, impacting individuals' sense of safety and freedom.
It's important to remember that each individual's experience with their sexual orientation is unique, and the psychodynamics can differ widely from person to person. The understanding and acceptance of homosexuality have evolved over time, but challenges and disparities still exist. Advocacy, education, and fostering inclusive environments are essential steps toward promoting understanding and well-being for homosexual individuals and the broader LGBTQ+ community.
16. **Gender Identity and Expression:** It's important to recognize that sexual orientation and gender identity are distinct aspects of a person's identity. While sexual orientation refers to whom one is attracted to, gender identity relates to one's internal sense of being male, female, a blend of both, or neither. Some individuals who identify as homosexual may also have diverse gender identities, such as transgender or gender-nonconforming, adding complexity to their psychodynamics.
17. **Coping Strategies:** LGBTQ+ individuals, including those who identify as homosexual, often develop coping strategies to navigate discrimination and stigma. These strategies can include resilience, humor, finding supportive communities, and seeking therapy or counseling to address mental health challenges.
18. **Media Representation:** Media plays a significant role in shaping societal attitudes and perceptions of homosexuality. Positive and accurate representation in media can contribute to increased acceptance and understanding, while stereotypes and negative portrayals can perpetuate discrimination.
19. **Education and Awareness:** Education and awareness initiatives are crucial in addressing prejudice and discrimination related to homosexuality. Schools, workplaces, and communities can implement programs to educate people about sexual orientation, promote tolerance, and prevent bullying.
20. **Healthcare Disparities:** LGBTQ+ individuals, including those who identify as homosexual, often face disparities in healthcare access and quality. Culturally competent healthcare providers and policies that address these disparities are essential for the well-being of this community.
21. **Aging and Long-term Relationships:** Like heterosexual individuals, homosexual individuals may desire and form long-term relationships, including marriages or partnerships. Understanding the unique challenges and needs of aging LGBTQ+ individuals is an important aspect of the psychodynamics, as they may face issues related to caregiving, legal recognition, and healthcare access in later life.
22. **Global Perspectives:** The psycho dynamics of homosexuality can vary significantly depending on cultural, social, and legal contexts. In some countries, homosexuality is fully accepted and integrated into society, while in others, it remains a criminal offense. Understanding these global perspectives is crucial for fostering international LGBTQ+ rights and acceptance.
23. **Generational Differences:** Attitudes and acceptance of homosexuality can vary between generations. Younger generations often report higher levels of acceptance, while older generations may have had different experiences growing up in less accepting times. Bridging generational gaps and fostering intergenerational dialogue is important for creating understanding and acceptance.
24. **Mental Health Resilience:** Many homosexual individuals demonstrate remarkable resilience and personal growth in the face of adversity. Understanding the factors that contribute to mental health resilience within this community can offer insights into developing effective support systems and interventions.
25. **Legal Advances:** Legal recognition and rights for LGBTQ+ individuals, including those who identify as homosexual, have evolved significantly in many parts of the world. These legal advances can have a profound impact on the psycho dynamics, as they can contribute to a sense of validation and acceptance.
In conclusion, the psychodynamics of homosexuality are multifaceted and influenced by a wide range of individual, social, cultural, and political factors. Promoting acceptance, understanding, and equality for LGBTQ+ individuals remains a critical endeavor for creating a more inclusive and compassionate society.
FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
In an overabundance of caution (unlike the mRNA COVID19 vaccines)
[11/3/2023] Cardinal Health Inc. has initiated a voluntary recall for all lots of six Leader brand ophthalmic products. The list the FDA provided on October 27 included five products branded as Leader. The list has been updated to include the sixth product.
Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratories brand eye drops.
The agency has updated the list of products to include the national drug codes (NDCs) that have been confirmed. FDA will provide additional information as it becomes available.
[10/30/2023] The FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website.
[10/27/2023] The FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their healthcare provider or seek medical care immediately. These products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up & Up
- Velocity Pharma
These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products.
CVS, Rite Aid, and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby, and Velocity may still be available to purchase in stores and online and should not be purchased.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at Medwatch; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
- Consult with your eye physician
Eye Drop Retailers and Product Information
Retailer/ Label | Product | Product Information | National Drug Code (NDC)* |
|---|---|---|---|
CVS Health | Lubricant Eye Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 0.5% | To be provided |
Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | To be provided | |
Lubricant Gel Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 1% | To be provided | |
Lubricant Gel Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 1% | To be provided | |
Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05% | To be provided | |
Lubricating Gel drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided | |
Lubricant Eye Drops 10 ml (single pack) | Propylene Glycol 0.6% | To be provided | |
Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | To be provided | |
Mild Moderate Lubricating Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.25% | To be provided | |
Leader (Cardinal Health) | Eye Irritation Relief 0.5 FL OZ (15 ml) | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 70000-0087-1 |
Dry Eye Relief 0.5 FL OZ (15 ml) | Carboxymethylcellulose Sodium 1% | 70000-0089-1 | |
Lubricant Eye Drops 0.5 FL OZ (15 ml) (single) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-1 | |
Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-2 (carton) 70000-0090-1 (bottle) | |
Dry Eye Relief 0.33 FL OZ (10 ml) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 70000-0088-1 | |
Lubricant Eye Drops 0.33 FL OZ (10 ml) | Polyethylene Glycol 0.6% | 70000-0587-1 | |
Rugby (Harvard Drug Group) | Lubricating Eye Drops 0.5 oz (15 ml) | Polyvinyl Alcohol 1.4% | 0536-1325-94 |
Lubricating Tears Eye Drops 0.5 oz (15 ml) | Dextran/Hypromellose 0.1%/0.3% | 0536-1282-94 | |
Rite Aid | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | To be provided |
Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | To be provided | |
Gentle Lubricant Gel Eye Drops 15 ml | Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% | To be provided | |
Lubricant Gel Drops 15 ml | Carboxymethylcellulose Sodium 1% | To be provided | |
Lubricating Gel Drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided | |
Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | To be provided | |
Target | Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%
| To be provided |
Up&Up Extreme Relief Dry Eye 15 ml (single pack) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided | |
Up&Up Extreme Relief Dry Eye 30 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | To be provided | |
Velocity Pharma LLC | Lubricant Eye Drop 10 ml (triple pack) | Propylene Glycol 0.6% | To be provided |
Walmart | Equate Hydration PF Lubricant Eye Drop 10 mL | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided |
Sunday, October 8, 2023
In a nationwide cohort of patients with chronic pain, the use of medical cannabis was associated with a 64% risk increase of arrhythmias compared with no use. This poses a potential health concern and is vital knowledge for any physician prescribing medical cannabis. The use of medical cannabis was not associated with an elevated risk of ACS or HF.
As the stigma surrounding cannabis wanes and its potential medicinal value becomes more widely accepted, an increasing number of people are turning to the plant for both recreational and therapeutic purposes. However, despite its growing popularity, our understanding of how cannabis affects the human body is still limited. While a body of evidence points to the therapeutic potential of cannabis, it is important also to consider the potential risks associated with its use. A study by Holt et al. presented at the 43rd European Society of Cardiology Congress
Treatment with medical cannabis for chronic pain is in popular demand, and a rising number of countries allow physicians to prescribe medical cannabis for pain management. However, data on drug safety is scarce. Studies have shown a risk of cardiovascular side effects following the use of recreational cannabis warranting further investigations into the safety of prescribing medical cannabis.
last fall, for instance, suggested a possible link between cannabis use and an increased risk of cardiovascular events, bringing into question its safety.
About the Study
Holt and colleagues conducted an observational study to examine the potential risk of cardiovascular events in 4,562 patients with chronic pain who were prescribed medical cannabis (cannabinoid, cannabidiol, or dronabinol) compared to a control group who weren’t taking the medication. Specifically, they looked at the risk of new-onset arrhythmias (abnormal heart rhythms), acute coronary syndrome (ACS, a condition caused by the sudden, reduced blood flow to the heart), and heart failure. The researchers used the Danish national registers to follow the cohort, who, importantly, did not have a history of arrhythmias, ACS, heart failure, or medical cannabis use prior to the study period (2018 to 2021). Patients from the exposed cohort were matched to controls in age group, sex, and chronic pain diagnosis.
The study found that the risk of new-onset arrhythmias was higher in the group prescribed medical cannabis compared to the control group, with a risk ratio of 1.64 (95% CI: 1.04-2.23) – a 64% relative risk increase. The 180-day absolute risks were 0.71% (95% CI: 0.47%-0.94%) for exposed subjects vs. 0.43% (95% CI: 0.37%-0.49%) for controls, indicating an absolute risk increase of 0.28% with cannabis use. This 0.28% absolute risk increase translates to one case of arrhythmia for every 360 users. However, the risk of ACS or heart failure was not elevated in the group prescribed medical cannabis compared to the control group.
A cause for alarm?
Given the lack of human data on medical cannabis and potential cardiovascular risks, these findings are certainly noteworthy. However, upon closer examination, the limitations of the study suggest that there may not yet be cause for alarm.
One potential source of selection bias in this study is the difference in comorbidities between the exposed and control groups. Comorbidities refer to the presence of health conditions that an individual may be experiencing in addition to their “main” condition or the condition of interest within the study. In this study, the exposed group had more comorbidities, including hypertension, ischemic heart disease, chronic kidney disease, and diabetes mellitus, than the control group, which could potentially affect the results if the exposed group was more vulnerable to certain adverse events due to their overall health status. For example, in patients with hypertension, the heart muscle may enlarge (a condition known as cardiac hypertrophy), which can also involve the growth of fibrous tissue and a decrease in connectivity between cells. These changes can disrupt the normal electrical properties of the heart and increase the likelihood of arrhythmias.
Another source of selection bias in this study is the fact that the exposed group had higher exposure to other medications compared to the control group. Other medications taken by the exposed group may interact with medical cannabis, altering the effects of both on the body and impacting susceptibility to CV concerns. It is also possible that other medications, if metabolized by the same enzymes in the body as CBD, could potentially interfere with the absorption, distribution, metabolism, and elimination of both substances. Notably, a significantly higher percentage of the exposed group (42.2%) were also taking opioid medications compared to the control group (12.3%). CBD has been shown to inhibit CYP2D6, an enzyme involved in the metabolism of opioids such as oxycodone, which may lead to an increase in the serum concentrations of these medications. In 2019, research by Dashi et al. revealed a link between opioid overdose and the occurrence of ischemic events, heart failure, and arrhythmias in patients hospitalized due to opioid overdose. Additionally, a review by Behzadi, Joukar, and Beik suggests that opioids can themselves trigger arrhythmias, and higher doses of these medications may exacerbate this effect.
The Bottom Line
Holt et al. showed that medical cannabis use was associated with a small increase in the risk of arrhythmias, but the presence of major confounds in this study stymies any meaningful interpretation of these findings with respect to the effects of cannabis per se. Those with pre-existing cardiovascular conditions may want to proceed with caution in light of the possibility that medical cannabis negatively impacts CV health, but ultimately, more research is needed.
Friday, October 6, 2023
FDA ‘remains unsatisfied’ with Philips’ handling of CPAP recall
Since Philips began its recall of millions of respiratory devices in June 2021, the FDA hasn’t been shy about criticizing how the company has handled the recall.
Certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines
And over two years in, despite Philips’ efforts, the agency “remains unsatisfied with the status of this recall,” according to an update it released Thursday and attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
This time around, the FDA is taking issue with the independent testing Philips commissioned—on a post-recall request from the regulator—to assess the safety of the polyester-based polyurethane (PE-PUR) foam at the heart of the recall. The foam, which was added to many of Philips’ CPAP and BiPAP machines and ventilators to muffle sound and vibrations, was found to break down over time and possibly release debris and chemicals into a user’s airflow.
Philips reaches first settlement in class-action CPAP lawsuit
Since the start of the recall, the FDA has warned that inhaling particles released by the disintegrating foam could potentially lead to internal and external irritation, headaches, asthma, nausea or “toxic or carcinogenic effects to organs, such as kidneys and liver.”
Meanwhile, though Philips initially issued similar warnings, it has since changed its tune, touting instead the results of the independent testing, which concluded that exposure to materials released by the foam “is unlikely to result in an appreciable harm to health in patients.”
Is the FDA overreacting?? Many people no longer trust the FDAs judgment, since the COVID-19 mRNA EUA.
Those findings clash with the FDA’s tally of more than 105,000 medical device reports (MDRs) related to the recalled devices that it received between April 2021 and the end of March of this year, including 385 reports of death—though both the FDA and Philips have been quick to note that MDRs are unvetted submissions and therefore their contents may not be directly linked to Philips’ devices.
Additionally, some experts have singled out the genotoxicity findings in the Philips-commissioned testing: The foam repeatedly tested positive for genotoxicity, and though the device maker said the results still fell within acceptable safety standards, experts interviewed in a recent ProPublica report argued that genotoxicity in any capacity is cause for “alarm,” since it denotes an ability to damage the genetic information within a cell, potentially leading to cancer-causing mutations.
It should be noted that genotoxicity was found in in vitro animal testing, not in a human Clinical Trial.
The FDA recall shows the inconsistency of the FDA's methodology as it approved an mRNA COVID-19 vaccine without a full approval process, yet recalled a previously approved device