The Taiwan Food and Drug Administration (TFDA) has been aware that the medicinal products containing cyproterone may lead to rare neoplastic meningiomas of which the risk level increases with doses. In order to ensure the public’s safety, the TFDA reassesses the clinical benefits and risks and decides to revise the indications of drugs containing cyproterone at high dose (50mg). The TFA also requests drug companies to include “patients with meningioma or with a history of meningioma” to the contraindication section of the Chinese package insert, and to provide the information about meningioma in the sections of “warnings and precautions” and “pharmacological properties”. License holders of the drugs in concern should complete the changes of Chinese package inserts before May 31, 2023. Otherwise the drug licenses could be revoked.
The TFDA reminds doctors to carefully assess the treatment benefit and effectiveness when prescribing drugs containing cyproterone to patients, and to carefully observe any early signs and symptoms of meningioma. The TFDA reminds patients that this drug is prescription-only and should be taken strictly according to doctor’s order.
The TFDA will continue to monitor the safety of this drug to protect patients’ safety. In case of any ADR events, healthcare professionals should report to the ADR reporting system.
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