Reporting Miralax Side Effects
If you or your child has experienced side effects while on Miralax, please report what you have experienced to the FDA if you are in the USA, and ask your doctor or your child’s doctor to report the side effects to the FDA as well. If the doctor refuses to file a report, then ask that he or she make a note in your medical records or your child’s medical records that you have requested them to report to the FDA and then ask for a copy of the medical records.
When you are reporting you aren’t saying that Miralax for sure caused your issues or your child’s issues. You are just reporting that the issue happened to you or your child while you or they were taking Miralax. It isn’t up to you to prove that Miralax caused the issue/s, you are just reporting your observations. If you have taken your child off of Miralax or you have stopped taking Miralax and the side effects have improved or gone away, please include that in your report.
The FDA needs to get enough reports of certain issues happening while on Miralax such as tics, anxiety, seizures, OCD, anger or rage, hallucinations, nightmares, panic attacks etc to make the connection and then take action. Please file a report for minor or severe side effects.
You can call 1-800-FDA-1088 to file your report. When you make your report on the phone please ask that a copy of your report be mailed to you.
You can also file your report online. The Medwatch Voluntary Report is a form you can fill out and submit to the FDA. It only takes a few minutes to fill out. You can also ask your physician or your child’s physician to file a separate report to the FDA with FDA Form 3500.
If you are in Canada you can file a report at Report a Side Effect to Canada Health.
You can also report your side effects or your child’s side effects directly to Bayer, the maker of Miralax. Click on Bayer Adverse Event Reporting and file your report with them. You can also request that your health care provider file a report as well. Bayer is required to report adverse events filed with them to the FDA annually.
Activist and Whistleblower, Erin Brockovich, has a website, The Community Healthbook has invited parents to report their child’s stories of Miralax injuries on her website. Please take the time to fill out a report with her as well.
Thank you for taking the time to file these reports.
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