Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
09/15/2022 Reporter Wu Liang-yi / Taipei Report
The Food and Drug Administration (FDA) announced today that anti-androgen medications containing "cyproterone," used to treat acne, hirsutism, contraception, and severe hypersexuality, may carry the risk of causing rare tumorigenic meningiomas. Patients who currently have or have had a history of meningioma should be prohibited from using these drugs.
The FDA explained that after reviewing domestic and international data and reassessing the clinical benefits and risks of drugs containing this ingredient, it has decided to revise the indications for high-dose (50mg) "cyproterone" medications. The Chinese product inserts for these drugs will now include "patients currently diagnosed with or with a history of meningioma" under contraindications, along with adding safety information related to "meningioma" in sections such as "Warnings and Precautions" and "Pharmacological Properties."
The FDA has required that license holders for drugs containing "cyproterone" must complete the revisions to the Chinese product inserts by May 31 next year. Failure to meet this deadline will result in the revocation of their licenses.
Hong Guo-deng, section chief of the FDA's Drug Division, stated that monitoring drug safety alerts from the EU, the UK, and other international sources revealed that medications containing this ingredient may pose a risk of causing rare tumorigenic meningiomas, with the risk increasing with cumulative dosage. Although no similar cases have been reported domestically, the new regulations were announced based on warnings from international data.
Currently, there are six drug licenses in Taiwan containing "cyproterone," divided into low-dose and high-dose uses. Low-dose formulations are used to treat acne, hirsutism, and contraception, while high-dose medications are prescribed for women with severe virilization symptoms or men with severe hypersexuality and prostate tumors.
Hong added that the annual National Health Insurance usage totals approximately 2 million tablets, which is relatively low. Patients have other treatment options available, so the lack of first-line medications is not a concern.
The FDA recommends that physicians prescribing "cyproterone"-containing drugs to patients should carefully assess the risks and benefits. During treatment, they should monitor for clinical symptoms and signs of meningioma and advise patients to seek immediate medical attention if they experience discomfort such as vision changes, hearing loss or tinnitus, loss of smell, progressively worsening headaches, memory loss, seizures, or limb weakness.
Source: https://health. ltn. com. tw/ article/ breakingnews/ 4058990
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Drugs with Cyproterone May Cause Rare Meningioma; FDA Urgently Bans Use for Some Patients
The Food and Drug Administration (FDA) announced today that anti-androgen medications containing "cyproterone," used to treat acne, hirsutism, contraception, and severe hypersexuality, may carry the risk of causing rare tumorigenic meningiomas. Patients who currently have or have had a history of meningioma should be prohibited from using these drugs.
The FDA explained that after reviewing domestic and international data and reassessing the clinical benefits and risks of drugs containing this ingredient, it has decided to revise the indications for high-dose (50mg) "cyproterone" medications. The Chinese product inserts for these drugs will now include "patients currently diagnosed with or with a history of meningioma" under contraindications, along with adding safety information related to "meningioma" in sections such as "Warnings and Precautions" and "Pharmacological Properties."
The FDA has required that license holders for drugs containing "cyproterone" must complete the revisions to the Chinese product inserts by May 31 next year. Failure to meet this deadline will result in the revocation of their licenses.
Hong Guo-deng, section chief of the FDA's Drug Division, stated that monitoring drug safety alerts from the EU, the UK, and other international sources revealed that medications containing this ingredient may pose a risk of causing rare tumorigenic meningiomas, with the risk increasing with cumulative dosage. Although no similar cases have been reported domestically, the new regulations were announced based on warnings from international data.
Currently, there are six drug licenses in Taiwan containing "cyproterone," divided into low-dose and high-dose uses. Low-dose formulations are used to treat acne, hirsutism, and contraception, while high-dose medications are prescribed for women with severe virilization symptoms or men with severe hypersexuality and prostate tumors.
Hong added that the annual National Health Insurance usage totals approximately 2 million tablets, which is relatively low. Patients have other treatment options available, so the lack of first-line medications is not a concern.
The FDA recommends that physicians prescribing "cyproterone"-containing drugs to patients should carefully assess the risks and benefits. During treatment, they should monitor for clinical symptoms and signs of meningioma and advise patients to seek immediate medical attention if they experience discomfort such as vision changes, hearing loss or tinnitus, loss of smell, progressively worsening headaches, memory loss, seizures, or limb weakness.
Source: https://health. ltn. com. tw/ article/ breakingnews/ 4058990