The FDA has just given approval for the extended release (XR) version of the antidepressant Effexor to be produced in a generic formulation. As with all such cases of named medications going generic, this carries benefits and risks. Indeed, the very language contained in the FDA press release should be cause for careful consideration and expanded vigilance.
Keith Webber, Ph.D., is the deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. This is the body that makes determinations on drugs’ safety and warning labeling concerns. Webber was quoted on the FDA website as saying, “The approval of this widely-used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs.”
This is obviously the case. There is nothing inherently wrong with generic medications. Generic labels of acetaminophen, ibuprofen, lansoprazole, omeprazole and other drugs that are available over the counter indisputably have improved the quality of human life.
However, this blog has kept track of the many continuing problems that are present in SSRIs and SNRIs like Effexor and Paxil. These problems have included the on-the-label acknowledged risk of increased suicidal thoughts and ideation, as well as a host of alleged links between pregnant mothers prescribed the medication and the formation of birth defects in their children.
Indeed, in the same press release where Webber cites the decision as part of the FDA’s desire to make safe drugs available, more sobering information follows: Generic venlafaxine hydrochloride will have the same safety warnings as Effexor XR.
Considering this medication still has cases pending against it pertaining to both the current acknowledged problem of increased suicidal thoughts among young patients and the potential of birth defects caused by the medicine, it gives one pause to think that the FDA is promoting it as “safe and effective” when giving permission for generic use.