Scientists discover strange link between vitamin D and pain

In continuation of my update on Vitamin D

Women with low vitamin D levels may face a more painful recovery after breast cancer surgery and could require significantly more opioid medication afterward, according to research published online in the journal Regional Anesthesia & Pain Medicine.

The findings suggest that breast cancer patients with vitamin D deficiency (below 30 nmol/L) might benefit from taking vitamin D supplements before undergoing a radical mastectomy.

Researchers say growing evidence points to vitamin D playing an important role in how the body senses and regulates pain. Scientists believe this may be connected to the vitamin's anti inflammatory properties and its effects on the immune system. Vitamin D deficiency is also frequently seen in people with breast cancer.

Study Examined Pain After Breast Cancer Surgery

To explore the connection, researchers carried out a prospective observational study at Fayoum University Hospital in Egypt between September 2024 and April 2025.

The study included 184 women with breast cancer who were preparing to have surgery to remove one breast. Half of the participants had vitamin D deficiency (below 30 nmol/L), while the other half had vitamin D levels above 30 nmol/L. The two groups were otherwise similar, with average ages of 44 and 42.

Doctors and nurses caring for the patients did not know their vitamin D status. All participants received the hospital's standard treatment before, during, and after surgery.

During the operation, patients were given fentanyl to control acute pain. After surgery, everyone received intravenous paracetamol every eight hours. Patients were also able to self administer tramadol, another opioid pain medication, by pressing a control button.

Patients With Low Vitamin D Needed More Opioids

Pain levels were recorded immediately after surgery and again at 6, 12, 18, and 24 hours later. Researchers also tracked nausea, vomiting, sedation levels, and length of hospital stay.

Patients with vitamin D deficiency were three times more likely to experience moderate to severe pain during the first 24 hours after surgery compared with patients who had adequate vitamin D levels.

Researchers noted that none of the patients in either group reported severe pain of 7 or higher on the standard 0 to 10 pain scale. The difference was entirely related to a higher number of patients experiencing moderate pain levels between 4 and 6.

The vitamin D deficient group also required more opioid medication. On average, these patients received 8 μg more fentanyl during surgery, which researchers described as a modest increase.

However, after surgery, the difference became much larger. Patients with low vitamin D used an average of 112mg more tramadol than those with sufficient vitamin D levels. The medication was patient controlled, with doses capped at 50mg per hour.

Vitamin D and Recovery Complications

Opioid medications can lead to side effects such as nausea, vomiting, drowsiness, and confusion. They also carry risks of dependence and addiction.

The study found postoperative nausea occurred more often among patients with vitamin D deficiency. Vomiting was only reported in the deficient group, although researchers said the difference was too small to be considered statistically significant.

The researchers acknowledged several limitations. Because the study was observational and conducted at a single medical center, it cannot prove that low vitamin D directly caused the increase in pain. The team also did not measure inflammatory markers that might explain how vitamin D influences pain. In addition, information about anxiety, depression, cancer stage, previous treatments, and sleep problems before surgery was not collected.

Even with those limitations, the researchers concluded, "Vitamin D deficiency is associated with a higher occurrence of moderate to severe postoperative pain and increased opioid consumption in patients undergoing unilateral modified radical mastectomy."

They added, "Preoperative vitamin D supplementation in breast cancer patients with vitamin D levels below 30 nmol/L may have a role in modulating postoperative pain."

https://rapm.bmj.com/content/early/2026/05/04/rapm-2025-107495

Scientists discover strange link between vitamin D and pain 

Scientists discover strange link between vitamin D and pain

In continuation of my update on Vitamin D 

Women with low vitamin D levels may face a more painful recovery after breast cancer surgery and could require significantly more opioid medication afterward, according to research published online in the journal Regional Anesthesia & Pain Medicine.

The findings suggest that breast cancer patients with vitamin D deficiency (below 30 nmol/L) might benefit from taking vitamin D supplements before undergoing a radical mastectomy.

Researchers say growing evidence points to vitamin D playing an important role in how the body senses and regulates pain. Scientists believe this may be connected to the vitamin's anti inflammatory properties and its effects on the immune system. Vitamin D deficiency is also frequently seen in people with breast cancer.

Study Examined Pain After Breast Cancer Surgery

To explore the connection, researchers carried out a prospective observational study at Fayoum University Hospital in Egypt between September 2024 and April 2025.

The study included 184 women with breast cancer who were preparing to have surgery to remove one breast. Half of the participants had vitamin D deficiency (below 30 nmol/L), while the other half had vitamin D levels above 30 nmol/L. The two groups were otherwise similar, with average ages of 44 and 42.

Doctors and nurses caring for the patients did not know their vitamin D status. All participants received the hospital's standard treatment before, during, and after surgery.

During the operation, patients were given fentanyl to control acute pain. After surgery, everyone received intravenous paracetamol every eight hours. Patients were also able to self administer tramadol, another opioid pain medication, by pressing a control button.

Patients With Low Vitamin D Needed More Opioids

Pain levels were recorded immediately after surgery and again at 6, 12, 18, and 24 hours later. Researchers also tracked nausea, vomiting, sedation levels, and length of hospital stay.

Patients with vitamin D deficiency were three times more likely to experience moderate to severe pain during the first 24 hours after surgery compared with patients who had adequate vitamin D levels.

Researchers noted that none of the patients in either group reported severe pain of 7 or higher on the standard 0 to 10 pain scale. The difference was entirely related to a higher number of patients experiencing moderate pain levels between 4 and 6.

The vitamin D deficient group also required more opioid medication. On average, these patients received 8 μg more fentanyl during surgery, which researchers described as a modest increase.

However, after surgery, the difference became much larger. Patients with low vitamin D used an average of 112mg more tramadol than those with sufficient vitamin D levels. The medication was patient controlled, with doses capped at 50mg per hour.

Vitamin D and Recovery Complications

Opioid medications can lead to side effects such as nausea, vomiting, drowsiness, and confusion. They also carry risks of dependence and addiction.

The study found postoperative nausea occurred more often among patients with vitamin D deficiency. Vomiting was only reported in the deficient group, although researchers said the difference was too small to be considered statistically significant.

The researchers acknowledged several limitations. Because the study was observational and conducted at a single medical center, it cannot prove that low vitamin D directly caused the increase in pain. The team also did not measure inflammatory markers that might explain how vitamin D influences pain. In addition, information about anxiety, depression, cancer stage, previous treatments, and sleep problems before surgery was not collected.

Even with those limitations, the researchers concluded, "Vitamin D deficiency is associated with a higher occurrence of moderate to severe postoperative pain and increased opioid consumption in patients undergoing unilateral modified radical mastectomy."

They added, "Preoperative vitamin D supplementation in breast cancer patients with vitamin D levels below 30 nmol/L may have a role in modulating postoperative pain.

https://rapm.bmj.com/content/early/2026/05/04/rapm-2025-107495

https://en.wikipedia.org/wiki/Vitamin_D

Scientists discover strange link between vitamin D and pain | ScienceDaily

Vitamin D Deficiency Linked to Fatigue, Studies Show

In continuation of my update on Vitamin D

Prevalence and Link to Fatigue

Approximately 40% to 75% of the teen and adult population in the United States is deficient in vitamin D, according to Raymond Francis in “The Great American Health Hoax.” ^[1] Low energy and occasional fatigue are commonly reported among individuals with low vitamin D status, according to a report on the silent epidemic of nutrient deficiencies. ^[2] The scale of the problem is vast, with estimates suggesting that nearly half of all adults may have insufficient levels, the report stated.

Vitamin D deficiency is not confined to a single demographic. Factors such as limited sun exposure, darker skin pigmentation, and indoor lifestyles contribute to widespread insufficiency, researchers said. The link between low vitamin D and fatigue has been documented in multiple studies, though many individuals remain unaware of their own deficiency status.

Mechanism: Vitamin D and Cellular Energy

Vitamin D supports mitochondrial function, which is responsible for cellular energy production, according to research cited in an article on fatigue and mitochondria. ^[3] The mitochondria act as the powerhouses of the cell, generating adenosine triphosphate (ATP) from nutrients. A deficiency may disrupt mitochondrial efficiency, contributing to feelings of lethargy, experts said. ^[4]

The role of mitochondria in energy production is central to understanding why vitamin D insufficiency can lead to persistent tiredness. As noted in the book “Dissolving Illusions,” proper mitochondrial metabolism is essential for normal cellular function, and any disruption can manifest as weakness or apathy. ^[5] Although that text focuses on vitamin C, the principle applies broadly to nutrients that support mitochondrial health, including vitamin D.

Supporting Studies

Multiple studies have reported a connection between low vitamin D levels and fatigue. A 2016 study of 200 female nurses in Iran found that low vitamin D levels accounted for 13% to 18% of reported prolonged tiredness, according to a review of nutrient deficiencies. ^[2] A 2019 study published in Nutrients similarly found that older adults with occasional fatigue had a significantly worse vitamin D status than those without fatigue, the review added. ^[2]

Other research has reinforced these findings. In a broader analysis, researchers noted that individuals frequently reporting low energy were more likely to have suboptimal vitamin D levels compared to their peers, according to an article on fatigue and mitochondrial function. ^[4] The consistency of the association across different populations suggests a robust relationship, though causation requires further investigation, scientists said.

Other Health Impacts

Beyond fatigue, vitamin D deficiency has been linked to several other health issues. Vitamin D directly modulates the body’s innate and adaptive immune responses, according to a review of the critical role of vitamin D in immune function. ^[6] Immune cells require adequate vitamin D to respond efficiently to threats, the review stated. Low levels have also been associated with increased susceptibility to infections and longer recovery times.

Vitamin D also influences bone health and cellular aging. Raymond Francis wrote that vitamin D is essential for calcium metabolism, supports bone health, helps control blood sugar, and protects against cancer. ^[1] The nutrient significantly increases the production of telomerase, an enzyme that repairs telomeres and slows aging, according to the same source. ^[1] These wide-ranging effects underscore the importance of maintaining optimal levels.

Solutions: Increasing Vitamin D Levels

Optimal vitamin D levels are considered to be above 50 nanograms per milliliter, and supplementation with 5,000 IU daily is recommended by some nutritionists, according to an interview on health testing and supplementation. ^[7] At-home blood tests can help individuals assess their current levels, the interview stated. ^[7] Testing allows for personalized dosing rather than generic recommendations.

The safety of higher vitamin D doses has been affirmed by recent reassessments. A news report noted that a “schoolboy error” in earlier guidelines led to overly cautious upper limits, and the Academy of Medicine has since acknowledged that higher intakes are not toxic for most people. ^[8] Dietary sources such as fatty fish, egg yolks, and fortified foods can also contribute, though supplementation is often the most reliable way to correct a deficiency, experts said.

Conclusion

Individuals experiencing unexplained fatigue may consider testing their vitamin D levels, clinicians advised. ^[7] Supplementation and dietary changes can help restore levels to the optimal range, though consulting a healthcare provider is recommended before starting any regimen, according to the interview. ^[7]

The evidence linking vitamin D deficiency to fatigue is supported by prevalence data, mechanistic studies, and clinical observations. Given the high rates of insufficiency in the general population, testing and appropriate supplementation offer a straightforward strategy for addressing a common but often overlooked contributor to low energy, researchers concluded.

https://en.wikipedia.org/wiki/Vitamin_D

Vitamin D Deficiency Linked to Fatigue, Studies Show 

Nicotinamide Linked to Lower Melanoma Risk Post Skin Cancer

In continuation of my update on Nicotineamide

Nicotinamide supplementation was associated with a decreased risk for melanoma among patients with a history of other skin cancers, according to a retrospective cohort study of more than 33,000 veterans.

The study, which won a first-prize poster award at the American Academy of Dermatology (AAD) 2026 Annual Meeting, “suggests that nicotinamide could potentially be effective for primary prevention of melanoma among patients who have had a prior nonmelanoma skin cancer,” noted Lee Wheless, MD, PhD, one of the senior authors, an assistant professor of dermatology at Vanderbilt University and a staff physician with the Tennessee Valley Healthcare System VA Medical Center, both in Nashville, Tennessee.

The effect of nicotinamide, at a dose of 500 mg twice daily, was statistically significant for invasive, but not in situ, melanoma, and it was consistent in both sun-exposed and sun-protected areas, he told Medscape Medical News.

The retrospective cohort study used data from the Veterans Affairs (VA) Corporate Data Warehouse from January 1, 2007, to December 31, 2024. It included a total of 33,581 patients with one or more prior skin cancers of any type. The cohort was predominantly White and men, with comparable mean ages (77.5 years in the exposed group vs 77.1 years in the unexposed group).

The US Department of VA offers nicotinamide, a vitamin B3 derivative, on formulary. Patients exposed to nicotinamide 500 mg twice daily were propensity score matched to unexposed patients based on “numerous skin cancer risk variables to make sure risks at specific timepoints in the patients’ lives matched up,” explained Wheless.

Baseline matching variables included age, sex, race, age at first skin cancer, number and year(s) of prior skin cancers of any type, number of dermatology visits after baseline, chronic lymphocytic leukemia, solid organ transplantation, exposure to acitretin, and field therapy.

More...

https://en.wikipedia.org/wiki/Nicotinamide

Nicotinamide Linked to Lower Melanoma Risk Post Skin Cancer

Could guava juice help prevent anemia?

A systematic review from Indonesia, published in the journal BMJ Nutrition, Prevention & Health, indicates that adding guava juice to the diet could boost hemoglobin levels in adolescent girls and pregnant women. This could potentially offer a low-cost dietary complement to iron supplementation, given the high prevalence of iron-deficiency anemia among females, especially in low- and middle-income countries (LMICs).

Iron deficiency anemia among young women

In 2021, anemia was estimated to affect about 45 % of pregnant women and 39.5 % of non-pregnant women worldwide. Indonesia had similar figures: 48.9 % among pregnant women and 32 % among adolescent girls. Women with severe anemia are twice as likely to die during pregnancy and postpartum, compared to those with mild anemia.

Iron deficiency is the primary cause of anemia, especially in LMICs. The reasons include poor dietary intake, high prevalence of infection, heavy bleeding during periods, frequent pregnancies, and low healthcare access.

Iron deficiency anemia is conventionally treated with iron supplementation, but oral iron can cause symptoms such as diarrhea or constipation, other gut symptoms, an unpleasant taste, and may be inaccessible to some women. Pregnancy can further complicate treatment, as physiological changes may decrease iron absorption during this period.

This has resulted in persistently low use of iron supplements, even with national nutritional programs like the Gerakan Nasional Aksi Bergizi or iron supplementation programs targeting pregnant women and adolescent girls.

Nutritional benefits of guava

Guava is a locally cultivated and inexpensive fruit. Its juice is rich in vitamin C, folate, antioxidants, flavonoids, and polyphenols, and other micronutrients. The current study aimed to examine the potential of guava juice as a natural adjunct to iron therapy.

Guava juice and iron supplements

This systematic review and meta-analysis included 17 Indonesian studies published between 2019 and 2024, with a total of 726 participants. Most studies were quasi-experimental, while two were randomized controlled trials (RCTs). The participants were pregnant women or adolescent girls, with numbers ranging from 15 to 230.

While the findings were encouraging, most of the evidence came from relatively small quasi-experimental studies rather than randomized trials

Most studies evaluated guava juice alongside iron supplementation, while a few used it alone or in combination with carrot or red spinach juice. Intervention periods ranged from five days to three months.

Eight studies compared guava juice plus iron supplementation with iron supplementation alone, although only five of these provided extractable data for the direct comparative meta-analysis. One study used papaya juice and another dragon fruit juice as comparators. The remaining seven studies had no control group.

The meta-analysis was limited to 12 studies because the others lacked usable data. The results were promising, consistently indicating a significant average increase of 1.7 g/dL in hemoglobin among pooled participants who consumed guava juice.

When stratified by participant type, adolescents had a mean improvement in hemoglobin levels of 1.5 g/dL, versus 1.8 g/dL among pregnant women.

Across five studies that directly compared guava juice interventions with iron-only controls, hemoglobin levels increased by an additional 1.3 g/dL on average in the guava juice groups. This was confirmed to be robust by sensitivity analyses, with little evidence of publication bias.

Possible physiological pathways

The degree of improvement in hemoglobin observed by the researchers is substantial enough to potentially move some individuals with mild or moderate anemia into non-anemic categories. Other experimental studies involving male athletes, anemic schoolchildren, and postpartum women have shown similar positive effects from both guava juice and guava fruit consumption.

This suggests the beneficial impact of guava’s high vitamin C and polyphenol content, irrespective of the form of consumption. Vitamin C improves the absorption of iron from non-heme sources, including iron supplements, by converting ferric iron into its more absorbable ferrous form.

Guava also contains folate, antioxidants, flavonoids, and polyphenols that may support red blood cell survival by reducing oxidative stress. The researchers suggest that juice preparation may improve compliance and could enhance nutrient availability, while promoting more consistent intake.

Study limitations

Despite the promising results, the review also noted limitations. All studies were conducted in Indonesia, limiting generalizability to other populations. Many studies had a moderate risk of bias, sample sizes were relatively small, and most were non-randomized designs. Missing data also reduced the size of the meta-analysis. The studies showed high heterogeneity due to differences in guava dosage, preparation, and duration.

Future follow-up research should include larger, well-designed RCTs across multiple countries with standardized reporting, including regimens and outcomes. These should include not only hemoglobin but also parameters such as transferrin and ferritin that reflect broader health impacts and long-term effectiveness. This would help identify the optimal dosage, dosing frequency, and duration of use.

Implementation research is also required to understand how far such an intervention could be embedded into existing programs, supporting its real-world relevance.

Conclusion

Overall, the study concludes that guava juice significantly improves hemoglobin levels in women and adolescent girls. The authors highlight the potential of guava juice as an affordable, culturally acceptable, and locally available dietary adjunct to iron supplementation and anemia prevention programs in resource-limited settings.

It is particularly relevant in tropical countries with high guava production, such as India and Indonesia. The authors suggest integrating guava juice into school nutrition programs, antenatal care packages, and community health initiatives.

This could be a sustainable, complementary strategy to prevent and treat mild-to-moderate anemia, aligning with the United Nations’ Decade of Action on Nutrition (2016–2025) and its dietary emphasis on local foods.

Could guava juice help prevent anemia?

Vitamin C may reduce cancer-linked digestive chemical reactions

In continuation of my update on Vitamin C

A new study from the University of Waterloo uses mathematical modeling to examine how Vitamin C affects chemical reactions in the digestive system that are linked to cancer development. 

Over the last several decades, North American diets have seen a steady increase in exposure to nitrates and nitrites: compounds found in cured meats as well as fruits and vegetables grown using polluted soil and water. While nitrates and nitrites play important roles in neurological and heart health, in the stomach, they can undergo a chemical reaction known as "nitrosation" and form chemicals that many scientists suspect increase cancer risk. 

Since at least the 90s, researchers have been studying the link between cancer and these compounds, with conflicting results. Our work suggests that the presence of dietary Vitamin C may help explain these inconsistencies." 

Dr. Gordon McNicol, post-doctoral researcher in applied mathematics and first author of the study

The team built a mathematical model of the salivary glands, stomach, small intestine and plasma, and simulated how nitrites and nitrates move through the body and change over time. Their model demonstrated that when Vitamin C is also present in food, such as leafy greens like spinach, which contain both Vitamin C and nitrate, it could decrease cancer risk. 

The study also suggested that taking Vitamin C supplements after each meal could have a moderate positive effect in reducing the formation of nitrosation products associated with cancer risk from dietary nitrites and nitrates, such as those found in foods like bacon and salami. 

The researchers hope these findings will support future nutrition research. 

"This work provides a mechanistic roadmap for future clinical and laboratory studies by identifying the key interacting drivers of these potentially harmful chemical reactions, including nitrite exposure, antioxidant intake, meal timing, gastric conditions and oral microbiome activity," said Dr. Anita Layton, professor of applied mathematics and Canada 150 researcher chair. "This model can help researchers design more targeted experiments and interventions, focusing on when and in whom nitrosation is most likely to occur." 

The research, "Vitamin C as a nitrosation inhibitor: A modelling study across dietary patterns and water quality," appears in the Journal of Theoretical Biology.

https://www.sciencedirect.com/science/article/pii/S002251932600069X?via%3Dihub

Vitamin C may reduce cancer-linked digestive chemical reactions

FDA Approves Palsonify (paltusotine) for the Treatment of Acromegaly in Adults

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly.

“With the FDA approval of our lead therapy Palsonify, today marks a new era for those living with acromegaly and also for Crinetics as a company,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We are very pleased to be fulfilling our commitment to transforming patient lives. This approval is the first to come from our deep pipeline of first-in-class, small molecule drugs. This would not be possible without the help and partnership of people living with acromegaly, their caretakers, our employees, and the clinical researchers and health care professionals who contributed to Palsonify’s successful development program. Thank you to all involved.”

The approval is based on data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials, which evaluated Palsonify’s safety and efficacy in previously treated and medically untreated adults with acromegaly. Across both trials, Palsonify consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.

Participants also reported significant reductions in signs and symptoms associated with acromegaly as measured by the Acromegaly Symptom Diary (ASD) — an FDA-aligned patient-reported outcome tool developed to capture the symptoms that matter to people living with acromegaly. Symptoms include headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling. Palsonify was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial.

Long-term results from the open-label extension (OLE) phases of both trials were presented at this year’s Endocrine Society’s annual meeting, ENDO 2025, providing further evidence of Palsonify’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile. Ninety-one percent of patients from PATHFNDR-1 and 97 percent of completers from PATHFNDR-2 enrolled in the OLE.

“The PATHFNDR clinical development program set a new standard for acromegaly treatment by demonstrating the ability of Palsonify to drive both biochemical and symptom control, regardless of the degree of underlying disease severity,” said Dr. Shlomo Melmed, Executive Vice President of Medicine and Health Sciences and Dean of the Medical Faculty at Cedars-Sinai, “The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with a rapid action and durable response that can consistently manage acromegaly.”

“For people living with acromegaly, treatment once meant burdensome injections, breakthrough symptoms, and lifestyle sacrifices just to stay on track,” said Jill Sisco, President of Acromegaly Community. “What matters most to our community – maintaining consistent control so the disease doesn’t control us – led us to partner with the FDA on Externally Led Patient-Focused Drug Development meetings. This new treatment reflects that our voices have been heard in shaping the next generation of acromegaly care.”

Palsonify is expected to be available in the U.S. in early October. Crinetics is ensuring broad access to Palsonify by working closely with payers, healthcare providers, and patient advocacy organizations to support those who may benefit from this treatment.

As part of this commitment, Crinetics has launched CrinetiCARE®, a comprehensive support program designed to assist people living with acromegaly throughout their treatment journey. CrinetiCARE provides disease and product education, benefit verification, financial assistance resources, and access to dedicated nurse educators who can offer support with treatment onboarding and ongoing adherence.

A Marketing Authorization Application (MAA) for paltusotine in acromegaly is currently under review for use in the European Union, and the current timeline for the Committee for Medicinal Products and Human Use (CHMP) opinion is the first half of 2026. Crinetics is in partnership with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize paltusotine for acromegaly in Japan.

Paltusotine is also being evaluated for the treatment of carcinoid syndrome in the pivotal Phase 3 CAREFNDR trial. Global enrollment for CAREFNDR is expected throughout 2025.

Palsonify (paltusotine) INDICATION:

Palsonify is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS:

Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue Palsonify if complications of cholelithiasis occur and treat appropriately.

Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when Palsonify treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly.

Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block may occur in patients with acromegaly and were reported in Palsonify clinical trials. Dosage adjustments of concomitant drugs that have bradycardic effects may be necessary.

Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended.

Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with Palsonify, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated.

ADVERSE REACTIONS:

Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.

FDA Approves Palsonify (paltusotine) for the Treatment of Acromegaly in Adults

Daily Multivitamin May Protect Against Cognitive Decline in Older Adults

In continuation of my update on Vitamin and their importance 

A daily multivitamin may provide cognitive benefits for older adults, according to a study published online Sept. 14 in Alzheimer’s & Dementia.

Laura D. Baker, Ph.D., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues assessed whether daily use of cocoa extract (containing 500 mg/day flavanols) versus placebo and a commercial multivitamin-mineral (MVM) versus placebo improved cognition in 2,262 older women and men (mean age, 73 years).

The researchers found that cocoa extract had no effect on global cognition. However, compared with placebo, daily MVM supplementation resulted in a statistically significant benefit on global cognition, with a more pronounced effect seen in participants with a history of cardiovascular disease. Benefits of MVM were also seen for memory and executive function. There were no significant interactions observed between cocoa extract and MVM for any of the cognitive composites.

"Our study showed that although cocoa extract did not affect cognition, daily multivitamin-mineral supplementation resulted in statistically significant cognitive improvement. This is the first evidence of cognitive benefit in a large longer-term study of multivitamin supplementation in older adults," Baker said in a statement. "It's too early to recommend daily multivitamin supplementation to prevent cognitive decline. While these preliminary findings are promising, additional research is needed in a larger and more diverse group of people."

Ref : Daily Multivitamin May Protect Against Cognitive Decline in Older Adults 

FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis

Celgene Corporation (NASDAQ: CELG)  announced the U.S. Food and Drug Administration (FDA) approval of  Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1

“The approval of Inrebic is another important milestone for Celgene and underscores our commitment to people living with blood cancers,” said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. “We are excited to provide Inrebic as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.”

“Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” said Ruben Mesa, M.D., FACP, Director of the Mays Cancer Center at UT Health San Antonio Cancer Center MD Anderson. “There has not been a new treatment approved for this disease in nearly a decade. With Inrebic, physicians and patients now have another option available for myelofibrosis.”

The Inrebic development program consisted of multiple studies (including JAKARTA and JAKARTA2) in 608 patients who received more than one dose (ranging from 30 mg to 800 mg),1 of whom 459 had myelofibrosis,1 including 97 previously treated with ruxolitinib.1 The JAKARTA study evaluated the efficacy and safety of once-daily oral doses of Inrebic compared with placebo in patients with intermediate-2 or high-risk, primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis who were previously untreated with a JAK inhibitor, had enlarged spleens (a condition known as splenomegaly), and had a platelet count of ≥50 x 109/L (median baseline platelet count was 214 x 109/L; 16% <100 x 109/L and 84% ≥100 x 109/L).1,2 In the JAKARTA study, spleen volume was reduced by 35% or greater, when assessed from baseline to the end of cycle 6 (week 24), with a 4-week follow-up scan, in 37% (35 of 96) of patients treated with INREBIC 400 mg versus 1% (1 of 96) of patients who received placebo (p<0.0001).1 INREBIC also improved the Total Symptom Score as measured by the modified Myelofibrosis Symptoms Assessment Form (MFSAF) v2.0 diary2 (night sweats, itching, abdominal discomfort, early satiety, pain under ribs on left side, bone or muscle pain) by 50% or greater when assessed from baseline to the end of cycle 6 in 40% of (36 of 89) patients treated with 400 mg, versus 9% (7 of 81) of patients who received placebo (p<0.0001).1

Inrebic has a Boxed Warning for serious and fatal encephalopathy, including Wernicke’s. Serious encephalopathy was reported in 1.3% (8 of 608) of patients treated with Inrebic in clinical trials and 0.16% (1 of 608) of the cases were fatal. Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Thiamine levels should be assessed in all patients prior to starting Inrebic, periodically during treatment, and as clinically indicated.1 Do not start Inrebic in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue Inrebic and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

In the JAKARTA study, serious adverse reactions occurred in 21% of patients treated with Inrebic 400 mg once daily (n=96), with the most common (≥2%) being cardiac failure (5%) and anemia (2%).1 Fatal adverse reactions of cardiogenic shock occurred in 1% of patients.1 Permanent discontinuation due to an adverse reaction occurred in 14% of patients. The most frequent reasons for permanent discontinuation in ≥2% of patients receiving Inrebic included cardiac failure (3%), thrombocytopenia, myocardial ischemia, diarrhea, and increased blood creatinine (2% each).1

Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received Inrebic. Adverse reactions requiring dosage interruption in >3% of patients who received Inrebic included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received Inrebic. Adverse reactions requiring dosage reduction in >2% of patients who received Inrebic included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).

“Inrebic is a much-welcomed new treatment for the myelofibrosis community,” said Ann Brazeau, Chief Executive Officer and Founder, MPN Advocacy and Education International. “This FDA approval marks an important milestone for people living with myelofibrosis as we embark on making greater strides in the diagnosis, understanding and treatment of this disease.”

https://pubchem.ncbi.nlm.nih.gov/compound/Fedratinib

https://en.wikipedia.org/wiki/Fedratinib

Is Green Tea a Fad or a Real Health Boost?

In continuation of my updates on Green tea

Green tea is a popular health trend, with many people sipping in hopes of deriving benefits from the brew.

There's nothing wrong with that, dietitians say -- green tea is a healthy drink loaded with antioxidants. But the jury's still out on many of its purported health benefits.

"Clinical trials related to green tea are still in their early stages," said Nancy Farrell Allen, a registered dietitian nutritionist in Fredericksburg, Va. "I say drink it, enjoy it. It's not going to hurt, and it might have worthy benefits to it. But nutrition is a science, and it takes time for our understanding to evolve."

Green tea's potential health benefits derive from catechins, which are powerful antioxidant compounds known as flavonoids, said Chelsey Schneider, clinical nutrition supervisor at Mount Sinai Beth Israel Cancer Center in New York City.

One catechin in particular, known as EGCG, is found at higher levels in green tea than in either white or black tea, she said.

"This compound can be even stronger than vitamin C and E, which are very, very strong antioxidants," Schneider said. Antioxidants help prevent damage to cells.

Green, black and white tea all come from the same plant, said Allen, who is a spokeswoman for the Academy of Dietetics and Nutrition.

Green tea is made from the leaves of the mature plant, while white tea is made of leaves plucked early in development. Black tea is made from green tea leaves that are laid out and covered with a damp cloth, she said.

"They dry and blacken and ferment a little, giving black tea that darker, richer flavor," Allen said. But this process also reduces levels of catechins in black tea.

Weight loss has been associated with green tea, with experts suggesting that its mixture of caffeine and catechins can enhance a person's metabolism and processing of fat, according to the University of California-Davis Department of Nutrition.

But it appears that folks have to drink a lot of green tea to get substantial weight loss benefits and carefully watch the rest of their diet, UC-Davis says.

Green tea also has been tied to heart health.

For example, green tea was shown to reduce "bad" LDL cholesterol in a 2018 study of more than 80,000 Chinese published in the Journal of the American Heart Association.

Evidence suggests catechins in green tea also could lower risk of heart attacks, help blood vessels relax and reduce inflammation, UC-Davis says.

Green tea even has been associated with a lower risk of some cancers.

The American Cancer Society says studies have linked green tea to a reduction in ovarian cancer risk. And UC-Davis said experimental models have shown that green tea might reduce risk of a variety of other cancers.

But a 2016 evidence review by the Cochrane Library concluded that there is "insufficient and conflicting evidence to give any firm recommendations regarding green tea consumption for cancer prevention."

Schneider said the research is limited. "Some small studies say green tea can maybe be preventative for certain cancers, like breast, ovarian, endometrial, pancreatic and oral cancers, but there aren't so many conclusive human trials that support that," she said.

Green tea also might help keep your brain younger. A 2014 study in the journal PLOS One found that Japanese who drank more green tea had significantly less decline in brain function, although researchers couldn't rule out the possibility that these folks might have other healthy habits that helped keep them mentally sharp.

One caveat with all of this research is that it tends to take place in Asian countries, where people drink much more green tea. There might be significant differences for Americans.

And the way you take your green tea could diminish any potential positive effects, Schneider added.

"A lot of people are adding processed white sugar to their green tea, which really makes something beautiful and healthy into something unhealthy," she said.

Adding milk or cream to your tea also might not be a good idea.

"There are some studies that say having milk in green tea can actually block the effects of you absorbing the antioxidant," Schneider said. "If it was me, I'd drink it straight up."

FDA Approves Sorilux for Adolescent Plaque Psoriasis

In continuation of my update on Sorilux(calcipotriene) 

 

Mayne Pharma Group Limited, announced that the US Food and Drug Administration (FDA) has approved Sorilux(calcipotriene) Foam, 0.005% in adolescents.

Sorilux is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

Psoriasis is a chronic disease of the immune system affecting approximately 7.5 million Americans each year[1]. The most common form, plaque psoriasis affects roughly 80 percent of people who have the condition.

Mayne Pharma's CEO, Mr Scott Richards, said "Sorilux is an elegant foam formulation that is marketed by Mayne Pharma's Specialty Brands sales team alongside recently launched LEXETTE™ (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing."

Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR® (tazarotene) Foam, Sorilux Foam, DORYX® MPC (doxycycline hyclate) delayed-release tablets and LEXETTE Foam. The Company also markets TOLSURA® (SUBA®-itraconazole) capsules used to treat certain fungal infections which was recently approved and launched this year.

https://en.wikipedia.org/wiki/Calcipotriol