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Please call and report your symptoms/adverse reactions, health problems caused by Mirana to Bayer and/or the FDA. It is CRITICAL that everyone report their problems caused by Mirana!
 
hailey56 Views: 1,484
Published: 8 years ago
 

Please call and report your symptoms/adverse reactions, health problems caused by Mirana to Bayer and/or the FDA. It is CRITICAL that everyone report their problems caused by Mirana!


If you have not already reported your adverse reactions/symptoms caused from Mirena to Bayer and the FDA please do so as soon as possible. It is critical every women having health problems caused by Mirena, REPORT WHAT HAS HAPPENED TO THEM SINCE GETTING MIRENA AND THEIR SYMPTOMS. My understanding is that when you call and report adverse reactions they are required to report it to the FDA. If you have not already submitted a internet report on Bayer's website (I had problems with the webpage accepting the information and it would only allow you enter a couple sentenses in the decribe problem field) please contact Bayer by phone, see contact info below. I have included the email we received from Bayer. When we called the Bayer, the representative was accusatory, argumentative, and ended up saying 'I can't understand you' (???) and said they would send some forms in the mail for us to fill out and hung up. Regardless, everyone needs to call or go online and submit a adverse reaction report, or call and report problems they have with Mirena, they are required by law to report it, otherwise nothing is ever going to change!

From Bayer:

We received your internet report notifying us about your concerns with our product Mirena.

Bayer HealthCare Global Pharmacovigilance USA is concerned about any events you may have experienced and is asking for your help in understanding the details. We are requesting you contact the Global Pharmacovigilance Response Center at 1-888-765-3203 to discuss this further. All information provided is voluntary and remains confidential. Thank you for your assistance in this matter. The Global Pharmacovigilance Response Center can be reached Monday-Friday from 8:00 AM to 4:30 PM EST.
Sincerely,

Bayer HealthCare Pharmaceuticals Inc.
Global Pharmacovigilance USA
PO Box 1000
Montville NJ 07045-1000
Phone: 1-888-765-3203

Other info taken from Bayer's webite/code of conduct: Reports of Adverse Events Involving Bayer HealthCare Products As an employee of Bayer HealthCare if you become aware of adverse information or an adverse event involving a Bayer HealthCare product, you must immediately (within 24 hours) report it. FDA regulations require Bayer HealthCare to report such adverse events to the FDA, under strict timelines. Because you are an employee of Bayer HealthCare, the date you learned of the adverse information
is imputed to Bayer HealthCare. You must report adverse event information regardless of whether you believe that the facility will report it and regardless of whether the adverse event appears to have been caused by, or related to, the use of a Bayer HealthCare product. For the complete details on what and how to report adverse events, please refer to your Division’s Compliance Policies and
Procedures.
 

 
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