Taiwan drug agency reexamines safety of hormonal contraceptives after EU warning

Taiwan's Food and Drug Administration is conducting a safety reassessment of contraceptive medicines that contain the synthetic progestins desogestrel and etonogestrel. This move follows a warning from the European Medicines Agency, which said prolonged use—defined as a year or more—may be associated with a modest rise in meningioma, a usually benign tumor of the brain and spinal-cord membranes. Liu Chia-ping of the TFDA outlined the review at a meeting of the Taiwan Association of Obstetrics and Gynecology, citing the EMA’s Pharmacovigilance Risk Assessment Committee recommendation that arose after a French epidemiological study identified the risk.

The EMA estimates the additional risk at one case per 67,300 women and advises that women with a history of meningioma avoid these hormones and that current users be monitored for symptoms such as vision changes, headaches, or seizures. In Taiwan, six approved contraceptives contain desogestrel and two contain etonogestrel, and no local meningioma cases linked to these drugs have been recorded in the last ten years.