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

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.

Many cannabis users are familiar with trichomes. A tiny little crystal you’ll find on the leaves and buds of cannabis flower. Trichomes are minuscule in size, but they impact marijuana in a huge way. If you want your cannabis to have a lovely flavor and aroma– and a good amount of CBD or THC– you want your cannabis to have some well-tended trichomes.  Trichomes are tiny growths that can be found on certain plants, including algae, lichens, and cannabis plants. The word trichome comes from the Greek word “trichōma,” which means “growth of hair.” This is a fitting name for trichomes. As they look a bit like tiny, frosty, sparkly hairs that cover a plant. While cannabis trichomes are not hairs, they do grow out of the cannabis plant much like a hair would. Springing from the plant’s surface during the flowering phase.  

What do trichomes do?

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.

FDA ‘remains unsatisfied’ with Philips’ handling of CPAP recall

We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the FDA's device center director, Jeff Shuren, said in an update this week. (Photo by Sarah Silbiger/Getty Images)

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

FDA ‘remains unsatisfied’ with Philips’ handling of CPAP recall

Give Me some Attitude

Insurance Company Attitude

PTSD vs. PTSI — The Arguments for Changing the Name – It's PTSI

What's in a name?  Everything.

"Shell shocked". That is what PTSD was called after World War II and after the Korean War. 

We now realize PTSD occurs after any severe traumatic event, accident or emotional stress both acute and chronic.

The symptoms of PTSD are typically categorized into four main clusters:

1. Re-experiencing Symptoms: These symptoms involve reliving the traumatic event, often through distressing memories, nightmares, or flashbacks. Individuals with PTSD may experience intense emotional or physical reactions when reminded of the trauma.

2. Avoidance Symptoms: People with PTSD may try to avoid reminders of the traumatic event. This can include avoiding specific places, people, activities, or even thoughts and feelings associated with the trauma. They might also have a reduced interest in activities they once enjoyed.

3. Negative Changes in Mood and Thoughts: PTSD can lead to significant changes in a person's thoughts and feelings. They may experience persistent negative emotions, such as fear, guilt, or shame. They might have trouble recalling specific aspects of the traumatic event, feel detached from others, or have difficulty experiencing positive emotions.

4. Arousal and Reactivity Symptoms: These symptoms involve heightened arousal and reactivity, such as irritability, anger outbursts, difficulty sleeping, and being easily startled. Individuals with PTSD may also struggle with concentration and may become hypervigilant or overly alert to potential threats.

The American Psychiatric Association (APA) added PTSD —  coined in 1980 for severe, trauma-related symptoms among veterans of military engagement — to the third edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM). 

While the recognition was monumentally important then, a strong case can be made to think and talk differently about the condition today. More than 40 years later,  it’s clear that a shift from “disorder” to “injury” is necessary, if not overdue.

Post-Traumatic Stress Disorder (PTSD) is a complex mental health condition that can have various biochemical effects on the body. While I can provide some insights, please keep in mind that our understanding of the precise biochemical mechanisms of PTSD is still evolving. Here are some key biochemical effects and factors associated with PTSD:

PTSD or PTSI has associated biochemical dysfunction as well with the following features.

The technology can now detect physical changes in the brain following post-traumatic stress (PTS), but it was NOT available in 1980. These changes may include alterations in neural connectivity, activation patterns, or even structural changes in specific brain regions.

While it is understood, and even accepted, that terminology and conceptual frameworks within medicine often require time to adapt and incorporate advancements, like the ones mentioned above, the time has come to change the current classification/diagnosis of PTSD to PTSI. The once “invisible“ wounds of brain injury following psychological trauma can now be

1. **Hypothalamic-Pituitary-Adrenal (HPA) Axis Dysregulation:** One of the most well-documented biochemical effects of PTSD is the dysregulation of the HPA axis. This system controls the body's stress response. In individuals with PTSD, there can be alterations in the levels of stress hormones such as cortisol. Some may have elevated cortisol levels, while others may have reduced sensitivity to cortisol.

2. **Neurotransmitter Imbalances:** PTSD has been associated with disruptions in neurotransmitters, which are chemical messengers in the brain. There can be alterations in serotonin, norepinephrine, and dopamine levels. These imbalances can contribute to mood disturbances, anxiety, and other symptoms of PTSD.

3. **Inflammatory Response:** Chronic stress, which is often a part of PTSD, can lead to chronic inflammation in the body. Inflammation is associated with various physical and mental health issues. Elevated levels of inflammatory markers, such as C-reactive protein (CRP), have been observed in some individuals with PTSD.

4. **Alterations in Brain Structure and Function:** Neuroimaging studies have shown that PTSD can lead to changes in the structure and function of the brain. The amygdala, which plays a crucial role in the processing of emotions, can become hyperactive, leading to heightened emotional responses. Conversely, the prefrontal cortex, involved in emotional regulation, may show decreased activity.

5. **Epigenetic Changes:** There is emerging research suggesting that trauma, including that which leads to PTSD, can induce epigenetic changes. These changes can affect gene expression and may be passed down through generations. Epigenetic modifications can play a role in the long-lasting nature of PTSD symptoms.

6. **Sleep Disturbances:** Many individuals with PTSD experience sleep disturbances, which can further exacerbate biochemical imbalances. Sleep disruption can impact neurotransmitter function, stress hormone levels, and overall well-being.

7. **Altered Immune Function:** Prolonged stress associated with PTSD can weaken the immune system, making individuals more susceptible to infections and other health issues.

It's important to note that not all individuals with PTSD will experience the same biochemical effects, and there is significant variability in how PTSD manifests. Additionally, the relationship between biochemical changes and the development or persistence of PTSD is complex and not fully understood.

Treatment for PTSD often involves a combination of psychotherapy, medication (such as antidepressants or anti-anxiety drugs), and lifestyle changes to address these biochemical imbalances and their associated symptoms. Early intervention and a comprehensive approach to treatment are key to helping individuals with PTSD manage their condition and improve their overall well-being. 

 observed in the brains of people diagnosed with post-traumatic stress and, thus, should be considered “injured.”

The efficacy of diagnostic imaging, and the importance of its role in determining treatment for the injured, should not be ignored when considering the effects — and the survivors — of severe trauma. The current model of a “disorder” does not consider the latest, widely accepted neuroscience developments and, thus, renders the “D” in PTSD to be clearly outdated, from a scientific perspective.

The use of brain scans to diagnose PTS has proved inconclusive, yet there is abundant evidence for changes in the structure and function of different areas of the brain involved in fear response and anxiety, regulation of emotions, cognitive processing, and memory. For example, Michael T. Alkire, M.D. — featured in a 60 Minutes segment about the use of SGB to treat PTSD — has demonstrated over-activation of the amygdala in patients with PTS as far back as 2015 in his work for VA Long Beach Healthcare System.

From a scientific perspective, the “D” in PTSD is outdated. Seeing is believing.

Stigma is a barrier to seeking help.

PTSD vs. PTSI — The Arguments for Changing the Name – It's PTSI

Read About the Study

Costco announces new $29 perk for shoppers after membership - and customers call it 'awesome' | The US Sun

New scam ??

COSTCO announces new $29 perk for shoppers after membership

Costco enters the digital telehealth market by aligning with Sesame, a telehealth network.  Especially interesting is the telehealth mental health perk, for $72.00

You get what you pay for.  Costco has entered a slippery slope, one which will backfire for them and their intended Costco Members.  Costco has a reputation for quality products, such as tires, food, and other specialty items. and exceptional guarantees and this flies in the face of its credibility.  Will COSTCO offer a refund if your are dissatisfied?

This is nothing but a ploy to bring business into the COSTCO PHARMACY, which is an established and credible pharmacy.  Why not get your prescription at COSTCO PHARMACY. After all you are there already.

However, why pay $29 to get the prescription from an unknown person from Sesame who may not even be an M.D. doctor.  Many of Sesame's providers are unsupervised Physician assistants or Nurse practitioners. It's important to note that both PAs and NPs are mid-level medical professionals. They're basically at the same level. However, NPs can work independently in many states that PAs can't. So, it places nurse practitioners above physical assistants in terms of practice independence. 

In order to make an appointment on the Sesame Telehealth Platform, you must enter. your credit card information and add several personal identifying information data. Is Sesame telehealth HIPAA compliant?

CAVEAT EMPTOR !!!

 

Costco announces new $29 perk for shoppers after membership - and customers call it 'awesome' | says  The US Sun, an online newspaper.