Product Liability Attorney Blog

The FDA has issued an update to the public that addresses the potentially harmful drug interactions between methylene blue and psychiatric drugs, including SSRIs like Paxil and Effexor.

The FDA's update provides even more information about adverse effects reports of a condition known as serotonin syndrome. Most of the cases of serotonin syndrome were reported to the FDA's Adverse Event Reporting System by patients who were taking both serotonergic psychiatric drugs as well as methylene blue. The patients also seemed to experience their conditions when they had parathyroid surgery, which is why they were taking methylene blue in the first place, since it can be used intravenously as a visualizing agent. The specific methylene blue was given in doses ranging from 1 mg/kg to 8 mg/kg.

Since the methylene blue isn’t currently FDA approved, there are limited data available on the drug’s uses under different conditions. So far, there is no way for healthcare professionals to fully understand the potential risks of serotonin syndrome for those patients taking serotonergic psychiatric drugs like Paxil or Effexor and methylene blue. One thing that is known is that not all serotonergic psychiatric medications are equal when it comes to serotonin syndrome and methylene blue. So far, the cases of patients that developed serotonin syndrome seemed to happen to those who took SSRIs like Paxil and Effexor, serotonin norepinephrine reuptake inhibitors (SNRI) and clomipramine.

This newest FDA update points out just how dangerous drug interactions can be. With all of the data showing the health risks associated with SSRIs like Paxil and Effexor when used on their own, it seems strange to even consider mixing those medications with any other drugs, much less those that aren’t approved yet. Perhaps that is why so many Paxil and Effexor patients have filed lawsuits after suffering from such harmful side effects. With these new data, more lawsuits will likely follow.