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The US Food and Drug Administration has placed its highest warning — a so-called black box warning — on a drug used to relieve menopausal hot flashes.
According to the FDA, women taking Veozah may need frequent blood tests to check for liver problems.
In rare cases, the drug can cause serious damage to the liver, and patients with symptoms such as fatigue, unusual itching, nausea, vomiting, light-colored stools, dark urine or yellow skin or eyes should tell their doctor and stop taking the drug. The FDA said in a statement on Tuesday Drug safety communication.
Astellas, the drug's manufacturer, said in a statement that patient safety is its top priority.
“It is important to note that the overall benefit-risk profile of Veozah has not changed and remains positive, but we want patients and healthcare providers to be aware of the potential side effects,” the company said. .
Veozah in 2011 Approved in 2023. It works without hormones to reduce hot flashes by blocking a receptor called neurokinin B, which plays a role in regulating body temperature in the brain.
Since its approval, the use of the drug has been steadily increasing. About 29,000 patients picked up the pills from retail pharmacies in the U.S. in May, the FDA said.
The FDA first warned in September that the drug could cause liver problems. He raised the alarm after reviewing the case of a man with liver damage who had been taking the drug for 40 days. After stopping the drug, the patient's symptoms gradually disappear and their liver function returns to normal.
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Everyone responds differently to medication based on their health, genes and other factors. That's why, the FDA says, it's impossible to know how likely any individual is to develop these liver problems.
If you are taking Veozah, it is important to be vigilant and consult with your doctor for monitoring.
The FDA recommends that patients have blood tests for liver function tests every month for the first three months and six to nine months after starting Veoza. Also, if recommended, they should stop treatment.