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‘Dirty drugs’ and schizophrenia: After 70 years, there has been a ‘game-changing’ development.

hesiti — Tue, 08 Oct 2024 12:42:04 +0000

Cameron Solnordal says medication for schizophrenia, the complex mental health condition he lives with, can be a burden.

A supporter of mental health organization SANE, Solnordal told SBS news that the side effects of antipsychotic drugs and the weight gain they often cause can be life-threatening and prevent people from taking them.

Solnordal says that when he started taking medication for schizophrenia twenty years ago, he gained 40kg in the first few years.

“When you’re learning about how medications affect you, and if you’re a new patient, you’re going to carry that burden because as well as feeling tired, you’re really tired, you’re eating all the time. and just part of the coping mechanism,” he said.

“It has a huge impact on dating. When people say they don’t want to take it, it’s because they hate the way they feel – that’s the number one reason.”

Recently, a new drug was approved for the treatment of schizophrenia by the United States Food and Drug Administration (FDA). It is the first time in more than 70 years that a new class of medicine has been approved for the treatment of this condition.

Cobenfy (originally called KarXT) is a combination therapy of two different drugs: xanomeline and trospium.

This drug targets a different set of receptors in the brain than existing antipsychotic drugs used to treat schizophrenia.

Although modern drugs work on the brain’s dopamine system, Cobenfy focuses on the cholinergic system, which plays an important role in memory, digestion, heart rate, blood pressure and movement.

Professor Ashley Bush, a researcher at the Florey Institute of Neuroscience and Mental Health in Melbourne, told SBS News she was “very pleased” with the FDA’s decision to approve Cobenfy.

“I think it gives hope. The psychiatric community is cautiously optimistic that this might be a new asset to add to the resources for schizophrenia. I think it gives hope for the patient and the psychiatrist,” he said.

What is schizophrenia?

Schizophrenia is a complex mental health condition that affects around 1% of the population, around 200,000 people in Australia and around 24 million people worldwide.

It is characterized by delusions, hallucinations, disorganized speech and behavior and catatonic behavior (lack of response to the environment or people).

Schizophrenia symptoms are often divided into positive symptoms, which include hallucinations or delusions, and negative symptoms, which include decreased mood and social withdrawal.

What medications are used to treat schizophrenia?

There are currently two types of medications used to treat schizophrenia, including “typical” antipsychotics, which were the first generation of schizophrenia medications developed in the 1950s, and “atypical” ” antipsychotics, which were introduced in the 1990s.

Common antipsychotics include drugs such as Chlorpromazine, which was the first antipsychotic drug to be formulated with compounds used to treat epilepsy and sedation.

Atypical antipsychotics include medications such as Clozapine and Risperidone.

However, the side effects of these drugs can be extensive and debilitating. Antipsychotics have been shown to cause weight gain, type 2 diabetes, elevated cholesterol, life-threatening constipation, and a decrease in white blood cells.

Arthur Christopoulos, lecturer in the department of Pharmacy and Pharmaceutical Sciences at Monash University, told SBS News that existing antipsychotics are “dirty drugs” because they target a large number of receptors and cause many side effects.

“[Cobenfy] he said, “It’s more targeted medicine.”

Where is Cobenfy from?

Christopoulos said the journey to get Cobenfy approved began nearly three decades ago after pharmaceutical researchers discovered molecules that could selectively target receptors known as important to control the neurological effects associated with Alzheimer’s disease and schizophrenia.

The drug xanomeline was tested on Alzheimer’s patients but the trials failed due to serious side effects. However, they showed that the drug significantly reduced the symptoms of psychosis.

Later, xanomeline was combined with trospium to reduce unwanted side effects and this combination became the drug that is now approved as Cobenfy.

Christopoulos and other Monash University researchers were involved in a global study to develop this drug.

Christopoulos said Cobenfy could be considered an “add-on” to current antipsychotic drugs and could be used alongside them.

“Targeting this receptor system, it’s a game changer,” he said.

Although the trials that led to its approval in the US were only five weeks long, the FDA said that patients who received Cobenfy “experienced a significant reduction in symptoms” compared to the placebo group.

Providing information for the drug warns that it can cause urinary retention, increased heart rate, and decreased bowel movement, and is not recommended for patients with liver failure.

Christopoulos said that while it may not be a “panacea” it offers a completely different option for medicine.

“It will have a huge impact on the lives of people with schizophrenia in Australia and internationally,” he said.

“If I had to choose, I would rather take this drug than the existing antipsychotics.”

Christopoulos said it was too early to say whether the drug would help treat what is known as ‘schizophrenia-resistant schizophrenia’, where people continue to have symptoms despite taking antipsychotic drugs.

Treatment-resistant schizophrenia affects about a third of people diagnosed with the disease.

When will it be available in Australia?

Christopoulos said it was unclear when Cobenfy would be approved by Australia’s Therapeutic Goods Administration (TGA) but said “it will happen”.

He said there were fast-tracks to TGA approval but it was uncertain whether they would be used.

A spokesperson for the TGA told SBS News that it had not yet received an application to register Cobenfy on the Australian Register of Therapeutic Goods.

“The TGA is aware that the United States Food and Drug Administration has approved Cobenfy. If the TGA approves the application, it is important to note that the TGA will review all the information independently and make its decision based on the Australian standards,” they said. .

Christopoulos also said that, without the Pharmaceutical Benefits Scheme, the drug could be too expensive for some people.

As for Australians living with schizophrenia, Solnordal said many people could be relieved by the arrival of a new medication option.

“If someone sat down and said ‘Let’s try to do something better with schizophrenia and treatment’ then of course people will hang their heads and say ‘finally!’

“It’s such a do-it-yourself approach with what we’ve got … we’re just managing day-to-day.”

#Dirty #drugs #schizophrenia #years #gamechanging #development

Banned 13 years ago, Nimesulide is still prescribed to children; Government Joins Sensitization Drive – News18

hesiti — Sat, 05 Oct 2024 03:43:57 +0000

Despite a 13-year ban on the use of the pain reliever and antipyretic drug Nimesulide in children, reports of side effects continue to reach the drug watchdog – indicating that the drug is still being prescribed , News18 has learned.

Following these results, the watchdog Indian Pharmacopeia Commission (IPC) has urged drug manufacturers to ‘warn’ pediatricians and other healthcare professionals about the importance of not giving this drug to children.

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) and is approved for sale for adults in India. It helps relieve pain associated with various disease states and reduce high fever that is not controlled by general medicine.

In 2011, the Union Ministry of Health and Family Welfare banned the use of Nimesulide in children under 12 years of age.

In many countries, products containing Nimesulide are not approved for children under the age of 12. This drug is considered hepatotoxic and children are considered at risk of developing liver disease, “Union Department of Health said in a statement dated March 11, 2011.

However, despite the ban, the Pharmacovigilance Program of India (PvPI) – which monitors and collects information on adverse drug reactions (ADRs) and adverse events related to pharmaceutical products – receives complaints.

According to the letter, obtained by News18, the Indian Pharmacopeia Commission (IPC) – which runs the Pharmacovigilance Program of India (PvPI) – has decided to launch an “action” on health professionals and consumers to do not use the drug Nimesulide in children under 12 years of age.

The IPC has written a letter to all drug manufacturers who have marketing authorization for the drug to initiate the process.

Publish information and post notices

While reminding that the Ministry of Public Health in January 2011 prohibited the manufacture, sale and distribution of the drug, the letter dated October 1 said, “PvPI is receiving reports that Nimesulide has caused adverse drug reactions from marketing authorization holders under PvPI.”

It also called for action in the interest of “pediatric patient safety” and urged all health professionals and concerned consumers not to prescribe or administer Nimesulide to minors. 12.

The letter placed the responsibility for the publication of this warning on marketing authorization holders or pharma companies where they are required to “tell this information and warning poster” to “pediatricians, consultants in their hospital and a professional center for spreading awareness…”

What does the new poster say?

A new poster prepared by PvPI to raise awareness, seen by News18, states that “Nimesulide is a painkiller” and is “prohibited for use in children under 12 years of age.”

Showing a child refusing to take the medicine, the poster reads that the drug can cause “liver toxicity, adverse skin effects such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis.”

An old practice, doctors who don’t know can still prescribe: Specialists

Dr. Dinesh Raj, a pediatrician at Delhi’s Holy Family Hospital, was surprised to see Nimesulide used so far.

“Nimesulide is banned in children but, surprisingly, it is still being used. Doctors may not know about the negative effects of Nimesulide in children,” he said while explaining that this medicine is used for fever and pain.

“Besides the common side effects of gastritis, vomiting, abdominal pain etc., it has been associated with serious side effects such as stomach bleeding and liver failure,” he added. by saying.

Dr GV Basavaraja, president of the Indian Academy of Pediatrics (IAP), told News18 that such a mistake can only be made by those who are old doctors and are not updated with the current guidelines.

Also, he said that in remote health care areas such as community health centers (PHCs) or community health centers (CHCs), many pediatricians are not available and are doctors who general or other counselors who give drugs to children. “In this situation, there is a great opportunity to prescribe Nimesulide as doctors (who treat adult patients) may not be aware of the contraindication in children.”

Basavaraja, who is also a renowned pediatrician based in Bengaluru, said that in the last 15 years, he has not written a single prescription for Nimesulide. “The IAP strongly recommends that doctors should not prescribe this drug to children and we will send advice to our 50,000 members again as a reminder.”

Echoing similar sentiments, Dr Maninder Dhaliwal, a pediatric pulmonologist at NCR-based Amrita Hospital, believes that not all doctors may be fully aware of the updated guidelines or may misinterpret the restrictions.

“In some cases, the changes in management are not as well communicated, perhaps in small or rural settings. I don’t think there is a pediatrician who prescribes nimesulide for fever. The prevention is clear but some doctors may prescribe it due to lack of awareness, since in adults it is being used,” Dr. Dhaliwal said.

He also said that “habit and familiarity with the drug in adult medicine can lead to a better understanding of nimesulide. Or sometimes the habits may continue even after regulatory changes, and if only it would be rare.”

#Banned #years #Nimesulide #prescribed #children #Government #Joins #Sensitization #Drive #News18