Skip to main content

No PTC label warnings for Mirena Yet by Bayer

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.

Comments

Restricted HTML

  • Allowed HTML tags: <a href hreflang> <em> <strong> <cite> <blockquote cite> <code> <ul type> <ol start type> <li> <dl> <dt> <dd> <h2 id> <h3 id> <h4 id> <h5 id> <h6 id>
  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.

Latest News

Purdue, Sacklers Agree to $7.4B Opioid Settlement

Categories: Opioids

Purdue Pharma and its owners, the Sackler family, have agreed to a $7.4 billion settlement to resolve thousands of lawsuits accusing the…

Paraquat Trials Scheduled for October 2025 & April 2026

Categories: Paraquat

A U.S. District Judge overseeing thousands of federal

UGA College of Pharmacy Gets $1M+ to Fight Opioid Crisis

Categories: Opioids

Faculty from the University of Georgia’s College of Pharmacy have been awarded a nearly $1.2 million grant from the Georgia Opioid Crisis…

Get 5 Free Medical Record Reviews – No Risk, No Contracts!      
Only 10 firms will be accepted!

Valid until February 28, 2025.