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FDA Approves Imaging Drugs That Can Help Surgeons Find Ovarian Cancer-Consumer Health News
Tuesday, November 30, 2021 (HealthDay News)-The US Food and Drug Administration approved a new imaging drug on Monday to help identify ovarian tumors during surgery.
The drug Cytalux (paforasianin) is intended to improve the surgeon’s ability to detect ovarian cancer during surgery on a patient. It is administered intravenously prior to surgery and is used in combination with an FDA-approved near-infrared fluorescence imaging system.
“The FDA’s approval of Cytalux helps to enhance the ability of surgeons to identify deadly ovarian tumors that may not be detected otherwise,” said the Deputy Director of the FDA’s Center for Drug Evaluation and Research. Dr. Alex Gorovets said. Agency news release. “Cytalux provides healthcare professionals with an additional imaging approach for ovarian cancer patients by complementing current methods of detecting ovarian cancer during surgery.”
Cytalux’s FDA approval was based on a study of 134 women aged 33-81 years. They received a dose of Cytalux and were evaluated during surgery with both normal light and fluorescent light. Approximately 27% of these women detected at least one cancerous lesion that was not detected by standard visual or palpation.
The most common side effects of Cytalux included nausea, vomiting, abdominal pain, flushing, dyspepsia, chest pain, itching and hypersensitivity. The FDA also warned that Cytalux could harm the foetation when given to pregnant females. She also stated that women should not take folic acid, folic acid, or supplements containing folic acid within 48 hours prior to Cytalux administration.
Authorities also warned that the use of Cytalux poses a risk of false negatives and false positives. The drug, marketed by On Target Laboratories LLC, was previously quickly tracked for FDA approval.
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What Are The Main Benefits Of Comparing Car Insurance Quotes Online
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