It seems Breckenridge was happy that the MHRA had been up to speed on the Seroxat scandal from the very beginning: “If you go back – and I read this out to the Health Select Committee – to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.
And here is what Breckenridge actually said to the Health Select Committee: “…What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, ‘As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion’. That was in 1990″.
I think the questions that arise are as follows: what exactly is a “data sheet” and how was it published and provided to patients in 1990? – because I can tell you that there was NO mention at all of withdrawal problems on the Patient Information Leaflet (PIL) that was provided in each box of Seroxat. Neither was there any advice to “discontinue therapy gradually”.
Also, given that the MCA (today’s MHRA) was aware that Seroxat caused withdrawal problems and one should “discontinue therapy gradually”, then please please tell me why there was no mention of these matters in the PIL. No one in their right mind could argue that the MCA had “nailed” the “so-called scandal of Seroxat”.
If the PIL did not inform patients about how to stop taking Seroxat and about the severity and frequency of withdrawal problems, then what did?