No PTC label warnings for Mirena Yet by Bayer

No PTC label warnings for Mirena Yet by Bayer

Introduction

Despite numerous studies suggesting links between Mirena (and other similar intrauterine birth control devices that use hormone levonorgestrel release) and pseudotumor cerebri (intracranial hypertension-IIH) and being the subject of several Pseudotumor cerebri (PTC) product liability lawsuits, Bayer Healthcare has shown no indications of updating the labels of Mirena IUD to adequately warn about a possible PTC link which includes symptoms like headaches, vision loss, and ringing of the ears.

No formal warning has yet been issued by the FDA to warn about the risk of PTC posed by the Mirena IUD, in spite of receiving hundreds of adverse event reports regarding complications from Mirena commonly involving side effects associated with PTC or IIH.

In April 2017, MDL No. 2767, (In Re:  Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], was established under Judge Paul A. Engelmayer in the U.S. District Court for the Southern District of New York. Currently, more than 200 complaints are a part of this MDL and allege that the pharmaceutical manufacturer minimized the link between the Mirena IUD and the risk of serious brain injuries, including pseudotumor cerebri, benign intracranial hypertension, and idiopathic intracranial hypertension.