FDA Issues Black-Box Warning for Menopause Drug Veozah Over Liver Injury Risk
Dec 17, 2024
Source: CNN
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The US Food and Drug Administration has issued a black-box warning to Veozah, a medication prescribed for menopausal hot flashes, due to potential risks of serious liver injury.
Key Points:
Black-Box Warning Issued:
It was the FDA, for instance, that recently put Veozah, approved in 2023, on its black-box warning list because it could cause severe liver damage to some users.
The drug’s manufacturer, Astellas, emphasized that the overall benefit-risk profile remains positive but acknowledged the need for increased patient awareness and monitoring.
Recommended Monitoring:
Patients under Veozah should be subjected to blood tests that evaluate their livers:
Monthly for the first three months.
Further tests at six and nine months.
Any signs of liver disease including fatigue, unexplained itching, nausea, vomiting, light-coloured stools, dark yellow urine, or yellow skin and yellow eyes should be promptly presented to healthcare providers.
Case Reported as Liver Injury:
The FDA increased the warning following a case where a patient presented with liver damage after being subjected to Veozah for 40 days.
The symptoms receded after the patient had stopped taking the medication.
How Veozah Works:
Veozah is a non-hormonal drug for the treatment of hot flashes during menopause by antagonizing the neurokinin B receptor, which mediates the central regulation of body temperature.
Since it was approved, it has been used more, and in May 2024, almost 29,000 prescriptions were filled.
FDA Guidelines for Patients:
These people are advised to be watchful and to regularly visit the doctors.
Monitor liver markers closely and withdraw the treatment if adverse effects are developed.
What This Means for Patients:
Veozah is the first nonhormonal alternative in the treatment of symptoms associated with menopause and has become used in healthcare services with greater restraint than ever before due to risk for liver injury. Both patients and healthcare providers must consider risks versus benefits and closely monitor their work.
Copyright © 2024 Pharmacy Pro. All rights reserved.
Copyright © 2024 Pharmacy Pro. All rights reserved.
Copyright © 2024 Pharmacy Pro. All rights reserved.
Source: CNN
The US Food and Drug Administration has issued a black-box warning to Veozah, a medication prescribed for menopausal hot flashes, due to potential risks of serious liver injury.
Key Points:
Black-Box Warning Issued:
It was the FDA, for instance, that recently put Veozah, approved in 2023, on its black-box warning list because it could cause severe liver damage to some users.
The drug’s manufacturer, Astellas, emphasized that the overall benefit-risk profile remains positive but acknowledged the need for increased patient awareness and monitoring.
Recommended Monitoring:
Patients under Veozah should be subjected to blood tests that evaluate their livers:
Monthly for the first three months.
Further tests at six and nine months.
Any signs of liver disease including fatigue, unexplained itching, nausea, vomiting, light-coloured stools, dark yellow urine, or yellow skin and yellow eyes should be promptly presented to healthcare providers.
Case Reported as Liver Injury:
The FDA increased the warning following a case where a patient presented with liver damage after being subjected to Veozah for 40 days.
The symptoms receded after the patient had stopped taking the medication.
How Veozah Works:
Veozah is a non-hormonal drug for the treatment of hot flashes during menopause by antagonizing the neurokinin B receptor, which mediates the central regulation of body temperature.
Since it was approved, it has been used more, and in May 2024, almost 29,000 prescriptions were filled.
FDA Guidelines for Patients:
These people are advised to be watchful and to regularly visit the doctors.
Monitor liver markers closely and withdraw the treatment if adverse effects are developed.
What This Means for Patients:
Veozah is the first nonhormonal alternative in the treatment of symptoms associated with menopause and has become used in healthcare services with greater restraint than ever before due to risk for liver injury. Both patients and healthcare providers must consider risks versus benefits and closely monitor their work.
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Copyright © 2024 Pharmacy Pro. All rights reserved.
Copyright © 2024 Pharmacy Pro. All rights reserved.