The Controversy Over The FDA Approval Of Lexapro

There has been much controversy over the U.S. FDA (Food and Drug Administration) approval of Lexapro in the last decade. Lexapro (escitalopram) is currently available as a generic, as its patent expired in 2012. When it was released for sale in the early 2000s, Lexapro was marketed as an improvement over the other antidepressants, especially Celexa (citalopram). The controversy was over the FDA approval of Lexapro, which is basically the same drug as Celexa, which was going off patent. Lexapro contains only the active S-enantiomer of citalopram, whereas Celexa contains both the active and inactive enantiomers of citalopram (racemic mixture).

The controversy over Lexapro ensued in the early 2000s as Lexapro was essentially the same drug as Celexa, and Lexapro was much more expensive than generic Celexa. And generic Celexa would have sufficed for the treatment of anxiety and depression, especially when Lexapro was much more expensive when Lexapro was still under patent. As Lexapro is currently off patent and is available as a generic, it is an SSRI to consider for anxiety and depression, as it is now priced much lower as a generic. Lexapro is associated with fewer side effects and less drug-drug interactions when compared to the other SSRIs.

So the question is- how do pharmaceutical companies get away with selling pure enantiomers of drugs (i.e. Lexapro) that are virtually the same drug as the racemic mixture (i.e. Celexa)? Sure, I prefer to prescribe Lexapro over Celexa now, as both are generic, and there are some advantages of Lexapro over Celexa with regards to side effects. But if Lexapro were still under patent and it was not available as a generic, then I would pick the cheaper alternative every time…generic Celexa. Amazing how the drug companies dupe people (they call it marketing) into thinking they are getting a better drug, justifying the higher expense. But in this case, the big difference in price between on-patent Lexapro and generic Celexa was not worth the expenditure for such little gain, in what was essentially the same drug. Go figure.

Imagine all that extra money paid by Medicaid, Medicare, 3rd-party insurers, and out-of-pocket costs from patients for a patented drug (Lexapro) that was virtually the same drug as the generic (Celexa). Those payers should be refunded, and the FDA needs better analysis of studies before approving these copycat drugs.

See my study here for further analysis of the controversial FDA indication of Lexapro for adolescent depression.