Tag Archives: side effects

FDA Approves Bristol Myers Squibb’s New Antipsychotic Drug Cobenfy for Schizophrenia Treatment

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The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride), for the treatment of schizophrenia, a chronic mental health disorder. Developed by Karuna Therapeutics and now owned by Bristol Myers Squibb, Cobenfy works by targeting cholinergic receptors unlike traditional antipsychotic medications that target dopamine receptors.

This marks a significant departure from the conventional approach to schizophrenia treatment, according to the FDA. Schizophrenia is a debilitating mental illness characterized by hallucinations, delusions, disorganized thinking, and behavioral disturbances. Those affected often struggle to maintain a grasp on reality and may experience cognitive impairments.

Globally, about 24 million people are living with schizophrenia, including 2.8 million in the U.S., where it ranks as one of the top 15 causes of disability. Tragically, the condition is linked to a shortened lifespan, with approximately 5% of patients dying by suicide, the FDA noted.

The approval of Cobenfy is seen as a hopeful development for individuals affected by schizophrenia. “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that profoundly impacts quality of life,” said Tiffany Farchione, Director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research. “This drug offers the first new approach to treating schizophrenia in decades, providing an alternative to previously prescribed antipsychotic medications.”

The effectiveness of Cobenfy was demonstrated in two clinical studies. Over a five-week period, patients’ symptoms were measured using the Positive and Negative Syndrome Scale (PANSS), a 30-item tool used to assess schizophrenia symptoms. Results showed that patients treated with Cobenfy experienced a significant reduction in symptoms compared to those on a placebo.

However, the FDA highlighted several side effects associated with the drug, including nausea, constipation, vomiting, increased heart rate, and diarrhea. Due to the risk of severe side effects, the agency advised against prescribing Cobenfy to patients with urinary retention, kidney, or liver disease.

Earlier this year, in March, Bristol Myers Squibb acquired Karuna Therapeutics for $14 billion, gaining exclusive rights to KarXT (Cobenfy). The company plans to launch the drug by the end of October, with a monthly cost of $1,850, or around $22,500 annually, according to Reuters.

Sales are projected to reach $2.5 billion in the U.S. by 2030. Bristol aims to provide insurance coverage for 80% of patients within the first 12 to 18 months of the drug’s release. To further assist patients, Bristol has introduced a support program called “COBENFY Cares.”

Manuka Honey emerges miracle drug for lung infection if combined with widely used ‘amikacin’

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A potential new treatment combining natural manuka honey with a widely used drug has been developed by scientists at Aston University to treat a potentially lethal lung infection and greatly reduce side effects of one of the current drugs used for its treatment.

Manuka honey can also be used to help treat wounds, injuries, improve oral health, soothe a sore throat and treat ulcers. The findings are published in the journal Microbiology.

The scientists in the Mycobacterial Research Group in the College of Health and Life Sciences at Aston University were able to combine manuka honey and the drug amikacin in a lab-based nebulisation formulation to treat the harmful bacterial lung infection Mycobacterium abscessus, said lead author and PhD researcher Victoria Nolan.

Manuka honey is long known to have wide ranging medicinal properties, but more recently has been identified for its broad spectrum antimicrobial activity. Now scientists have found that manuka honey has the potential to kill a number of drug resistant bacterial infections such as Mycobacterium abscessus – which usually affects patients with cystic fibrosis (CF) or bronchiectasis.

Manuka honey could help to clear deadly drug-resistant lung infection – research/Photo:Microbiology Society

According to the Cystic Fibrosis Trust, CF is a genetic condition affecting around 10,800 people – one in every 2,500 babies born in the UK – and there are more than 100,000 people with the condition worldwide. The NHS defines bronchiectasis  as a long-term condition where the airways of the lungs become widened, leading to a build-up of excess mucus that can make the lungs more vulnerable to infection..

In the study, the researchers used samples of the bacteria Mycobacterium abscessus taken from 16 infected CF patients. They then tested the antibiotic amikacin, combined with manuka honey, to discover what dosage was required to kill the bacteria.

Dr Jonathan Cox, senior lecturer in microbiology, Aston University said: “By combining a totally natural ingredient such as manuka honey with amikacin, one of the most important yet toxic drugs used for treating Mycobacterium abscessus, we have found a way to potentially kill off these bacteria with eight times less drug than before.”

As part of the study the team used a lab-based lung model and nebuliser – a device that produces a fine spray of liquid often used for inhaling a medicinal drug. By nebulising manuka honey and amikacin together, it was found they could improve bacterial clearance, even when using lower doses of amikacin, which would result in less life-changing side-effects to the patient.

In the UK, of the 10,800 people living with CF, Mycobacterium abscessus infects 13% of all patients with the condition. This new approach is advantageous not only because it has the potential to kill off a highly drug resistant infection, but because of the reduced side effects, benefitting quality of life and greatly improving survival chances for infected CF patients.

Mycobacterium abscessus is a bacterial pathogen from the same family that causes tuberculosis, but this bug differs by causing serious lung infections in people (particularly children) with pre-existing lung conditions, such as CF and bronchiectasis, as well as causing skin and soft tissue infections. The bacteria is also highly drug resistant.

Currently, patients are given a cocktail of antibiotics, consisting of 12 months or more of antimicrobial chemotherapy and often doesn’t result in a cure. The dosage of amikacin usually used on a patient to kill the infection is 16 micrograms per millilitre. But the researchers found that the new combination using manuka honey, required a dosage of just 2 micrograms per millitre of amikacin – resulting in a one eighth reduction in the dosage of the drug.

Until now Mycobacterium abscessus has been virtually impossible to eradicate in people with cystic fibrosis. It can also be deadly if the patient requires a lung transplant because they are not eligible for surgery if the infection is present.

 

 

 

 

COVID Side Effect: Using germicidal lamp damages corneas in eyes

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In a paper published in the journal of Ocular Immunology and Inflammation, physicians from the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine reported that several patients using germicidal lamps in an attempt to sanitize against the coronavirus, developed painful inflammation of the cornea, a condition called photokeratitis. These consumer-available ultraviolet (UV) emitting devices were being used in an attempt to eliminate coronavirus from homes and offices.

“During the height of the pandemic, we noticed an increased number of patients coming in with irritation, pain and sensitivity to light,” said first author and Bascom Palmer resident Jesse Sengillo, M.D. “We realized this was after direct exposure to germicidal lamps that emit UV light in the C range to kill bacteria and viruses. This can be quite a painful experience for the patient, but with prompt topical lubrication and antibiotics to prevent infection, patients often do very well.”

UV photokeratitis occurs when the cornea is overexposed to ultraviolet radiation. This can happen at high elevation, where less UV rays are absorbed by the atmosphere, or near water, snow or other reflective surfaces in the environment. A few hours after exposure, patients experience burning in their eyes and sometimes intense light sensitivity.

Numerous germicidal lamps are on the market, and while they may be safe for at-home use, customers need to pay close attention to manufacturer recommendations to prevent damage to the eyes and skin.

“The patients we met were not aware of these recommendations, and many were unknowingly exposed at work” said co-author and fellow resident Anne Kunkler. “For UV-C emitting devices, it is best to leave the room while the device is on. Our patients were directly exposed to the light for various lengths of time. A few hours later, they felt discomfort and sought medical attention.”

Feeling eye discomfort?

Dr. Sengillo and colleagues encourage anyone feeling eye discomfort after exposure to one of these devices to promptly seek medical attention a medical professional from an ophthalmologist.

While germicidal lamps are being purchased to protect people during the pandemic, this study did not attempt to address whether they are effective in destroying coronaviruses. “There are many COVID-19 related publications recently. It is important that we disseminate information accurately and responsibly to avoid public confusion.”

Dr. Sengillo and colleagues note that some UV-C emitting germicidal devices are proven to be effective in killing various microbes and viruses, but to the authors knowledge, they have not been tested against COVID-19 specifically yet. “Our study was not designed to answer that question. If you choose to use these lamps, just make sure to follow manufacturer recommendations closely to avoid unnecessary injury,” said Dr. Sengillo.

Epileptic drugs linked to stroke in case of Alzheimer’s

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Antiepileptic drugs may increase the risk of stroke among persons with Alzheimer’s disease, said a new study from the University of Eastern Finland.

The risk remains the same whether the drugs are old or new antiepileptic drugs, said the study published in the Journal of the American Heart Association.

The study, conducted at the University of Eastern Finland and funded by the Academy of Finland, was based on the nationwide register-based MEDALZ cohort that includes all community-dwelling persons with clinically verified diagnosis of Alzheimer’s disease in Finland during 2005–2011 (70,718 people).

Data on antiepileptic drug use was compiled from the Finnish Prescription Register to assess the risk of stroke associated with antiepileptic drug use, and each antiepileptic drug user was matched to a non-user.

It was found that the risk of stroke was more during the first three months of antiepileptic drug use, and remains elevated after taking into account several chronic disorders, socio-economic position and use of concomitant medications.

According to another study from the same research group, persons with Alzheimer’s disease use antiepileptic drugs more often than persons without Alzheimer’s disease. The difference, which cannot be explained by epilepsy, is evident in antiepileptic drug use around the time when Alzheimer’s disease was diagnosed.

Up to 1% of population regularly requires chronic antiepileptic treatment to control epilepsy. Other indications for antiepileptic drug use include neuropathic pain and dementia-related behavioural symptoms in persons with Alzheimer’s disease.

The present findings show that persons with Alzheimer’s disease are particularly susceptible to adverse events, hence, the use of antiepileptic drugs for other indications than epilepsy should be carefully prescribed for this vulnerable population.

 

Never mix energy drinks with alcohol, warns study

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A key ingredient of energy drinks could be exacerbating some of the negative effects of binge drinking, said a new study sending a warning to many people who mix energy drinks with alcohol to counteract the sedative nature of alcohol, tricking users into feeling more awake and less drunk than they really are.

Researchers from the University of Portsmouth and the Federal University of Santa Maria in Brazil tested the effects of taurine, a key ingredient of many energy drinks, and alcohol on social and fear responses in zebrafish, and found that taurine seemed to increase the fear-reducing properties of alcohol, but also affected social communication.

Co-author of the study Dr Matt Parker, Senior Lecturer in Behavioural Pharmacology and Molecular Neuroscience at the University of Portsmouth, said: “The effects of mixing alcohol and energy drinks is yet to be established. This study is the first to show that the two together may be exacerbating some of the negative effects of binge drinking; that is reduction of fear and problems in social communication while intoxicated, which collectively increase the risk of fighting, violence and participation in risky behaviours.”

In the study, published in the Journal of Psychiatric Research, the researchers tested how taurine and alcohol (at volumes reflecting levels that would induce moderate human intoxication) affected the behaviour of 192 zebrafish. The fish were divided into shoals (with four fish per shoal) and were exposed to either just water, taurine and alcohol separately or taurine and alcohol for one hour. Their shoaling behaviours were then analysed at different time intervals at 0-5 minutes, 30-35 minutes and 55-60 minutes. The fish were also tested for their fear-like responses to a predator by dividing the tank into four areas, with the furthest area used to mimic a predator fish.

The fish that were exposed to both alcohol and taurine had fewer interactions with other fish in the shoal compared to those exposed to water alone or just alcohol. These fish also showed more ‘risky’ behaviour, spending more time in the predator zone than other groups.

Dr Parker said: “We found that the addition of taurine, an ingredient in many ‘energy’ drinks, appears to exacerbate risky choices in zebrafish, as well as reducing their social cohesion. Taken together, these data appear to suggest that mixing alcohol and taurine might be a factor in increasing some of the negative effects of alcohol. People should be aware that drinking energy drinks in combination with alcohol may impair their judgement, and should do so with caution.”

Unnecessary pill-popping leads to dementia, finds new study

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A new study by University of Sydney has found that excessive use of medication increases dementia, particularly unnecessary or inappropriate medications. Nearly 2,500 people were examined for the study conducted in collaboration with Yale University and University of Kentucky.

The number of people living with dementia around the world is 50 million. In Australia alone, it is currently 425,000, which means dementia costs the country more than $15 billion per year and it is currently the second leading cause of death in Australia.

"Our study found that following a diagnosis of dementia in older people, medication use increased by 11 per cent in a year and the use of potentially inappropriate medications increased by 17 per cent," said lead author Dr Danijela Gnjidic, from the Faculty of Pharmacy and Charles Perkins Centre at University of Sydney.

The researchers listed inappropriate or unnecessary medications such as sleeping tablets, pain drugs, depression drugs and acid reflux drugs (proton pump inhibitors). "These medications are typically recommended for short term use but are commonly used for long term by people with dementia," she said.

Among the reasons for this include inadequate guidelines, lack of time during physician patient encounters, diminished decision-making capacity, difficulties with comprehension and communication, and difficulties in establishing goals of care.

"The key is to communicate closely with general practitioners, pharmacists and other health professionals to make informed decisions and to practice good medicine management techniques to minimise the risk of side effects.Deprescribing unnecessary medications may improve an individual’s quality of life and can reduce unnecessary healthcare cost," said researchers.

The study has been published Journals of Gerontology: Medical Sciences.