Why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask
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Allergic Rhinitis (AR) can be an intermittent or persistent, seasonal or perennial immunologic inflammatory condition affecting the nasal mucosa. Sneezing, itching of the nose, eyes, and throat, rhinorrhea, and nasal congestion with positive IgE reaction to specific allergen triggers form the features of this frequently encountered condition. AR can be associated with other comorbid conditions like asthma, eczema, chronic or recurrent sinusitis, cough, tension, and migraine headaches. It impairs the quality of life and causes a significant healthcare burden (1).
Early and Late Phase Reactions in AR:
Upon exposure to allergens, histamine, a preformed mediator is immediately released from the mast cells. This triggers early-phase reactions like sneezing, itching, and rhinorrhea. A late-phase allergic response occurs due to infiltration of histamines into nasal mucosa leading to nasal congestion. Leukotrienes also have an inflammatory effect on the upper airways leading to increased nasal blood flow and secretions (2).
Advancements in AR management:
AR and patient care management has significantly improved over the past few decades owing to the various guidelines developed by Allergic Rhinitis and its Impact on Asthma (ARIA) and others. Prompt diagnosis, allergen avoidance, and pharmacotherapy are the mainstay of treatment for AR. Antihistamines (AH), intranasal corticosteroids, leukotriene receptor antagonists (LTRAs), decongestants, mast cell stabilizers, cromolyn, immunotherapy, probiotics, and biologics are some of the management options for AR (3).
Importance of Considering LTRAs and AH in AR:
The rationale behind using LTRAs like montelukast and AH like fexofenadine for AR is due to the involvement of histamine and cysteinyl leukotrienes (LTs) in the allergic response (2). LTRAs and AH are the commonly prescribed drugs for AR as LTRAs block cysteinyl leukotriene-activated inflammation in the nasal lavage fluids and airways thus attenuating nasal obstruction and rhinorrhea whereas AHs selectively inhibit histamine 1 receptor (H1R)-mediated vaso-permeability and vasodilatation attenuating rhinorrhea and congestion (4).
Complementary effects of LTRAs with AHs:
AHs improve the daytime nasal symptoms of AR like stuffy, runny, and itchy nose and sneezing. LTRAs improve the nighttime symptoms of AR like nasal congestion on awakening, difficulty going to sleep, and nighttime awakenings (4). These two drugs are used in combination as they are more effective than monotherapy. They both block the two important mediators of inflammation with complementary effects thus effectively reducing the symptoms.
Montelukast is a type 1 cysteinyl LT receptor antagonist and its anti-inflammatory effect is aimed at treating seasonal and perennial allergic rhinitis while fexofenadine, an active metabolite of terfenadine, is a selective antagonist of the H1 receptor that does not cross the blood-brain barrier and has anti-inflammatory properties for treating AR (5).
Review of literature:
Montelukast Fexofenadine(MF) FDC more efficacious than Montelukast Levocetirizine(ML) FDC:
A randomized, open-label, prospective, two-arm, comparative, multicentric study evaluated the efficacy and safety of montelukast 10 mg + fexofenadine 120 mg (MF group) fixed-dose combination (FDC) with montelukast 10 mg + levocetirizine 5 mg FDC (ML group) in AR administered once daily for 14 days. The study reported that the total symptom score (nasal symptoms + ocular symptoms) was more effectively reduced in the MF group (93.86%) than in the ML group (87.71%).
The total nasal symptoms score and the ocular symptom score reduction were better in the MF group (92.52% and 95.34%) than in the ML group (85.58% and 92.23%) respectively suggesting that montelukast + fexofenadine was more efficacious than montelukast + levocetrizine for symptom reduction.
Montelukast Fexofenadine (MF) FDC also showed a better Global impression score for efficacy and tolerability by investigators and patients based on their response to the therapy than the Montelukast Levocetirizine (ML) suggesting that the MF combination is more efficacious than ML (6).
Take home points:
References:
1. Bernstein JA, Bernstein JS, Makol R, Ward S. Allergic Rhinitis: A Review. JAMA. 2024;331(10):866-877. doi:10.1001/jama.2024.0530.
2. White M, Rothrock S, Meeves S, Liao Y, Georges G. Comparative effects of fexofenadine and montelukast on allergen-induced wheal and flare. Allergy Asthma Proc. 2005;26(3):221-228.
3. Linton S, Burrows AG, Hossenbaccus L, Ellis AK. Future of allergic rhinitis management. Ann Allergy Asthma Immunol. 2021;127(2):183-190. doi:10.1016/j.anai.2021.04.029
4. Feng Y, Meng YP, Dong YY, Qiu CY, Cheng L. Management of allergic rhinitis with leukotriene receptor antagonists versus selective H1-antihistamines: a meta-analysis of current evidence. Allergy Asthma Clin Immunol. 2021;17(1):62. Published 2021 Jun 29. doi:10.1186/s13223-021-00564-z
5. Everardo PG, Magdalena GS, Maria Elena GP, Vanessa CM, Gabriela SC. Bioavailability assessment of fexofenadine and montelukast in a fixed-dose combination tablet versus the components administered simultaneously. Allergol Immunopathol (Madr). 2021;49(4):15-25. Published 2021 Jul 1. doi:10.15586/aei.v49i4.89
6. Nayak Prateek, Drinivas CV, Chandrasekharan S. A randomized, open-label, prospective, comparative, multicentric study to evaluate the efficacy and safety of montelukast and fexofenadine fixed-dose combination vs montelukast and levocetrizine fixed-dose combination in allergic rhinitis. Indian journal of clinical practice. August 3, 2013;24(3).
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Kozhikode: A woman from Perambra in Kozhikode has accused the authorities at the Government Medical College Hospital (MCH) of neglecting her during childbirth, leading to complications that required five surgeries, including a hysterectomy.
The woman, a resident of Cheruvannur Grama Panchayat, claimed that she had been under the care of a gynaecologist at MCH, during her pregnancy. According to the woman, during a body scan in the ninth month of her pregnancy, it was discovered that the umbilical cord was wrapped around the neck of her fetus. However, the child continues to be in poor health due to complications during delivery.
On January 13th, the woman was admitted to the medical college hospital. Despite her deteriorating health condition, she stated that there was a shortage of medical staff to attend to her. In addition, she claimed that one of the doctors on duty misbehaved with her for crying in pain. It was only after her mother raised an alarm that a group of doctors attended to her. However, the child remains in an unhealthy condition even now due to complications during delivery.
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Following the delivery, the woman faced several health challenges, which led her to undergo five surgeries, including a hysterectomy due to excessive bleeding during delivery, over the next three months.
She and her husband are now seeking strict action against the gynaecologist and the attending lady doctor, alleging negligence and misconduct. The husband, who was working abroad at the time, claimed that he lost his job as he had to stay in India for an extended period to care for his wife. The couple has filed complaints with both the local police and the health department, urging an investigation into the matter. They are also seeking financial compensation for the suffering they endured.
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Kochi: In a significant ruling, the Kerala High Court has quashed the case against Dr Beena Bahuleyan, an assistant professor at Kozhikode Medical College, who had been accused of refusing to examine a 17-year-old girl involved in a missing person case.
The court’s decision came after Beena filed a petition to dismiss the charges against her. The case dates back to September 2016 when a 17-year-old girl went missing and was found after seven days near the Super Specialty Block of Kozhikode Medical College. She was taken to the gynaecology department for a medical check-up, but it was alleged that Dr Beena refused to examine the girl.
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According to the recent media report by TOI, the prosecution alleged that Beena expressed unwillingness to conduct the examination, leading to the girl being produced before the magistrate without a medical certificate. When the magistrate insisted on the certificate, the police had to return to the hospital to get the document.
As a result, the magistrate issued a case under Section 166B of the Indian Penal Code (IPC), which deals with the treatment of a victim, based on a police report. The case alleged that Dr Beena’s refusal to perform the examination violated the law. Dr Beena then approached the High Court, seeking to quash the charges.
However, Dr Beena claimed that she had examined the girl but was called to the emergency operation theatre for another critical case. By the time she returned, both the police and the girl had left the hospital. Beena further argued that the charge under Section 166B of the IPC was not applicable in this case, as the law specifically pertains to situations involving victims of sexual assault, which was not relevant in this instance.
After reviewing the police report on the incident, the court directed the Director of Health Services to conduct an inquiry into the matter and take appropriate action based on the findings. Additionally, the court instructed the State Police Chief to investigate the allegations made by Dr Beena against K.K. Biju, the then Circle Inspector of the Chevayur police station.
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Alappuzha: The Kerala police have registered a case against four doctors after a family accused them of failing to detect genetic disorders in their unborn child before birth, leading to severe complications.
The incident took place at a hospital in Alappuzha, where the baby was born with severe deformities.
According to the PTI report, the accused included two female doctors attached to the Kadappuram Government Women and Child Hospital in Alappuzha, along with two doctors from private diagnostic labs, according to the Alappuzha South police.
The police registered an FIR on Tuesday based on a complaint lodged by Anish and Surumi, a couple from Alappuzha.
They alleged that the doctors failed to detect or disclose the genetic abnormalities during prenatal scans, instead assuring them that the reports were normal.
The couple also claimed that they were shown the baby only four days after delivery, according to the complaint.
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The FIR stated that Surumi, 35, was undergoing treatment for her third pregnancy at Kadappuram Women and Child Hospital.
On October 30, Surumi was admitted for delivery. However, she was referred to Government Medical College Hospital (MCH) in Vandanam, Alappuzha, citing the absence of fetal movement and heartbeat, the FIR said.
On November 8, the baby was delivered following surgery at MCH and was found to have severe internal and external deformities, the FIR stated, news agency PTI reported.
Meanwhile, one of the accused doctors, responding to the allegations, said she had treated Surumi only during the initial months of her pregnancy.
“I provided care for three months at the beginning of her pregnancy. The reports shown to me indicated issues with the fetus’s growth,” she said.
The doctors associated with the diagnostic labs, however, maintained that there were no errors in the scan reports.
The police registered a case invoking Sections 125 (act endangering life or personal safety of others), 125 (b) (where grievous hurt is caused, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which may extend to ten thousand rupees, or with both) of Bharatiya Nyaya Sanhita (BNS) against the accused.
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USA: Recent studies have provided promising insights into the benefits of tadalafil and sildenafil, two commonly prescribed medications for erectile dysfunction (ED). The findings, published in The American Journal of Medicine, suggest that these medications not only improve sexual health but also contribute to lower risks of mortality, cardiovascular disease, and dementia, with tadalafil showing particularly notable advantages.
“Tadalafil also provided similar benefits for patients experiencing lower urinary tract symptoms,” Dietrich von Kuenssberg Jehle, Department of Emergency Medicine, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, US, and colleagues reported.
Erectile dysfunction and lower urinary tract symptoms, often resulting from conditions like benign prostatic hyperplasia and bladder neck obstructions, are common among men and are linked to a higher risk of cardiovascular disease. Phosphodiesterase-5 (PDE-5) inhibitors, including tadalafil and sildenafil, are commonly prescribed to treat erectile dysfunction and may also provide cardiovascular benefits due to their ability to promote vasodilation.
Against the above background, the researchers assessed the effects of PDE-5 inhibitors on all-cause mortality, cardiovascular disease, and dementia in middle-aged men with erectile dysfunction and lower urinary tract symptoms over a three-year follow-up period.
For this purpose, the researchers conducted a longitudinal study using data from 50 million US men in the TriNetX database. The study included men aged 40 or older who were prescribed tadalafil or sildenafil following a diagnosis of erectile dysfunction or tadalafil after a diagnosis of lower urinary tract symptoms between 2004 and 2021.
Three-year outcomes were assessed, including all-cause mortality, cardiovascular disease, and dementia, comparing men on PDE-5 inhibitors to those not using these medications. Propensity matching was employed to adjust for demographics and eight pre-existing conditions.
The following were the key findings of the study:
• The final cohort included 509,788 men with erectile dysfunction and 1,075,908 men with lower urinary tract symptoms.
• Both tadalafil and sildenafil were linked to significantly reduced risks of:
• All-cause mortality (RR: 0.66 for tadalafil, 0.76 for sildenafil)
• Myocardial infarction (RR: 0.73 for tadalafil, 0.83 for sildenafil)
• Stroke (RR: 0.66 for tadalafil, 0.78 for sildenafil)
• Venous thromboembolism (RR: 0.79 for tadalafil, 0.80 for sildenafil)
• Dementia (RR: 0.68 for tadalafil, 0.75 for sildenafil)
• Tadalafil provided more significant benefits than sildenafil in patients with erectile dysfunction.
• In men with lower urinary tract symptoms, tadalafil was similarly associated with reduced risks of mortality, cardiovascular disease, and dementia.
“The findings showed that the use of tadalafil and sildenafil in erectile dysfunction patients was associated with reduced risks of mortality, cardiovascular disease, and dementia, with tadalafil offering greater benefits. Additionally, tadalafil provided similar advantages for patients with lower urinary tract symptoms,” the researchers concluded.
Reference:
Jehle, D. V. K., Sunesra, R., Uddin, H., Paul, K. K., Joglar, A. A., Michler, O. D., Blackwell, T. A., Gaalema, D., Hayek, S., & Jneid, H. (2024). Benefits of Tadalafil and Sildenafil on Mortality, Cardiovascular Disease, and Dementia. The American Journal of Medicine. https://doi.org/10.1016/j.amjmed.2024.10.039
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