Latest news with #TherapeuticGoodsAdministration
AU Financial Review
2 days ago
- Business
- AU Financial Review
TGA approves weight-loss drug to treat sleep disorder
Australia's medicines regulator has approved the use of a GLP-1 weight-loss drug to treat people with sleep apnoea for the first time, broadening the applications for the popular drugs beyond diabetes and heart disease. US pharmaceutical giant Eli Lilly said on Wednesday the Therapeutic Goods Administration (TGA) had approved the use of its Mounjaro weight-loss drug to treat moderate-to-severe obstructive sleep apnoea in adults with obesity.
9 News
3 days ago
- Health
- 9 News
First medicine for sleep apnoea approved for use by the TGA
Your web browser is no longer supported. To improve your experience update it here The Therapeutic Goods Administration has approved the first medicine to treat sleep apnoea. Mounjaro, which has the active ingredient tirzepatide, is widely used to treat type 2 diabetes. However, the TGA has today expanded the drug's usage to include obstructive sleep apnoea for adults living with obesity. A medicine used to treat type 2 diabetes has now been approved for use in adults with obstructive sleep apnoea and obesity. (iStock) This makes Mounjaro the first and only medicine for obstructive sleep apnoea in Australia. The drug has not been listed on the Pharmaceutical Benefits Scheme and will only be available through private prescription. Mounjaro can now be used to treat moderate-to-severe obstructive sleep apnoea in adults living with a body mass index (BMI) of 30 or more. Mounjaro has been approved to treat sleep apnoea in adults living with obesity. (CNN) Mounjaro cannot be used to treat type 1 diabetes, or by children and teenagers under 18 years old. Side effects associated with Mounjaro can include an upset stomach, injection site-related side effects, and low blood sugar. Obstructive sleep apnoea is the most common of all sleeping disorders and is thought to affect around 780,000 Australian adults. It occurs when a person's upper airway becomes blocked, causing breathing to be repeatedly interrupted during sleep. Professor Brendon Yee is a respiratory and sleep physician at the Woolcock Institute of Medical Research who was involved in a clinical trial of Mounjaro for obstructive sleep apnoea. Yee said the TGA decision was a "long-awaited development" in the field of sleep medicine. "For the first time, people with weight-related obstructive sleep apnoea can be treated with a medicine that addresses the underlying cause of their condition," Yee said. "This marks a significant milestone in the treatment of this debilitating sleep disorder. "Obstructive sleep apnoea can affect anyone, and obesity is the single greatest cause of the condition. "At least 70 per cent of people living with obstructive sleep apnoea also live with obesity." health national medical medicine Sleep obesity CONTACT US
The Advertiser
3 days ago
- Business
- The Advertiser
Tech giant sued over sleep aid foam inhalation 'risk'
An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous. In the lawsuit filed on Monday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards. Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression. "There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement. The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system. Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges. "The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims. Philips did not conduct any risk analysis on the products until early 2021, the government agency says. Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year. After this date, Philips allegedly sold a further defective device, the Trilogy 100. This contained silicone foam which could become detached from its housing, obstructing the air path. Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood. The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs. A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall. "The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said. The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021. This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients". Philips would review the court documents filed by the TGA and engage constructively as required, she said. An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous. In the lawsuit filed on Monday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards. Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression. "There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement. The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system. Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges. "The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims. Philips did not conduct any risk analysis on the products until early 2021, the government agency says. Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year. After this date, Philips allegedly sold a further defective device, the Trilogy 100. This contained silicone foam which could become detached from its housing, obstructing the air path. Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood. The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs. A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall. "The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said. The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021. This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients". Philips would review the court documents filed by the TGA and engage constructively as required, she said. An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous. In the lawsuit filed on Monday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards. Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression. "There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement. The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system. Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges. "The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims. Philips did not conduct any risk analysis on the products until early 2021, the government agency says. Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year. After this date, Philips allegedly sold a further defective device, the Trilogy 100. This contained silicone foam which could become detached from its housing, obstructing the air path. Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood. The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs. A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall. "The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said. The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021. This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients". Philips would review the court documents filed by the TGA and engage constructively as required, she said. An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous. In the lawsuit filed on Monday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards. Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression. "There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement. The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system. Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges. "The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims. Philips did not conduct any risk analysis on the products until early 2021, the government agency says. Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year. After this date, Philips allegedly sold a further defective device, the Trilogy 100. This contained silicone foam which could become detached from its housing, obstructing the air path. Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood. The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs. A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall. "The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said. The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021. This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients". Philips would review the court documents filed by the TGA and engage constructively as required, she said.
9 News
3 days ago
- Health
- 9 News
Tech giant sued over risk from sleeping aids
Your web browser is no longer supported. To improve your experience update it here An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous. In the lawsuit filed yesterday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards. An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. (Getty Images/iStockphoto) Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression. "There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement. The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system. Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges. "The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims. Philips did not conduct any risk analysis on the products until early 2021, the government agency says. Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year. After this date, Philips allegedly sold a further defective device, the Trilogy 100. This contained silicone foam which could become detached from its housing, obstructing the air path. Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood. The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs. A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall. "The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said. The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021. This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients". Philips would review the court documents filed by the TGA and engage constructively as required, she said. national Australia courts Sydney New South Wales Technology Tech CONTACT US
West Australian
3 days ago
- Health
- West Australian
Tech giant sued over sleep aid foam inhalation 'risk'
An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action. Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous. In the lawsuit filed on Monday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards. Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression. "There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement. The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system. Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges. "The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims. Philips did not conduct any risk analysis on the products until early 2021, the government agency says. Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year. After this date, Philips allegedly sold a further defective device, the Trilogy 100. This contained silicone foam which could become detached from its housing, obstructing the air path. Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood. The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs. A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall. "The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said. The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021. This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients". Philips would review the court documents filed by the TGA and engage constructively as required, she said.
