Taiwan Drug Regulator Reassesses Cancer Risk of Contraceptives
核心洞察
Taiwan's Food and Drug Administration is reexamining contraceptives containing desogestrel and etonogestrel after the EMA flagged a small increased meningioma (搜索) risk with prolonged use.
The EMA's PRAC in July recommended updated safety information, citing a large French study linking one year or more of desogestrel use to intracranial meningioma (搜索).
Taiwan has six approved contraceptives containing desogestrel and two containing etonogestrel, with no local meningioma (搜索) reports linked to either hormone in 10 years.
Taiwan's Food and Drug Administration (TFDA) is reexamining the safety of contraceptive medications containing the synthetic hormones desogestrel and etonogestrel, following a European Medicines Agency (搜索) warning of a small increased risk of meningioma (搜索) with prolonged use. The TFDA issued a drug safety alert on Sept. 2 for medical professionals and the public, and is conducting a safety reassessment of products containing the two hormones, TFDA official Liu Chia-ping said at a forum held by the Taiwan Association of Obstetrics and Gynecology.
The European review was triggered by a large French epidemiological study that found a small increased risk of intracranial meningioma (搜索) among women who used desogestrel for one year or more. The EMA's Pharmacovigilance Risk Assessment Committee recommended updated safety information in July, and the recommendation was included in a direct communication to EU healthcare professionals on Aug. 6. Risk rose with longer use and may be higher in women who had previously used other progestogens associated with meningioma, including cyproterone, nomegestrol, medroxyprogesterone and chlormadinone. The EMA estimated one additional meningioma case per 67,300 women using the medicines, and the PRAC advised that women with current or past meningioma should not use them, while current users should be monitored for signs and symptoms.
Meningiomas arise in the tissue surrounding the brain and spinal cord and are usually benign but can cause serious problems depending on size and location. Symptoms cited by the TFDA include changes in vision, hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, and weakness in the arms and legs. Taiwan has six approved contraceptives containing desogestrel and two containing etonogestrel, and the TFDA said it has received no reports of meningioma (搜索) associated with either hormone over the past 10 years, based on data valid as of July 14.
Source: Focus Taiwan