Similar Drug Approval Problems With Zoloft and Paxil

SIMILAR DRUG APPROVAL PROBLEMS WITH ZOLOFT AND PAXIL 

Through FOIA, I have had the opportunity to review the Zoloft Summary Basis of Approval (1988). Many of the problems that plagued the NDA of Prozac were also rampant in the NDA for Zoloft, including numerous violations of protocol, the use of concomitant long-acting benzodiazepines, high dropout rates, many negative studies, and no evidence of efficacy in hospitalized patients. In fact, the efficacy of Zoloft was considered questionable until the last minute before its final approval (discussed in chapter 13). 

Through FOIA and materials obtained as an expert witness in product liability cases against GlaxoSmithKline, I found similar problems to Prozac in regard to the approval process for Paxil, especially miscoding suicidal behavior as emotional lability and hiding or misinterpreting data on suicidality (see subsequent sections in this chapter). 

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