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Medical Devices / Postmarket Safety

ANSM Sees Uptick in Adverse Event Reports for Bayer IUD

Nov. 27, 2017

France’s National Agency for the Safety of Medicines reported a major uptick in adverse advents associated with Bayer’s Mirena intrauterine device.

More than 2,700 adverse events reported were associated with the IUD between May 15 and Aug. 4, 2017, including 870 with anxiety symptoms, ANSM said. The number of adverse event reports for the device totaled 510 from its marketing launch in 1997 to May 15, 2017. 

The European Medicines Agency said earlier this month there is insufficient data to establish a direct connection between the occurrence of the reported adverse effects,  including anxiety, and the IUDs, which are indicated to prevent pregnancy or to treat abnormal menstrual bleeding. 

But ANSM said it will launch a pharmacoepidemiology study to assess the frequency of certain adverse effects because its survey results echoed the findings of an analysis based on health insurance data. The analysis assessed how frequently certain undesirable effects occurred with levonorgestrel IUDs compared to those with copper and revealed “a low but increased risk” of anti-anxiety drug use in women with Mirena.

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