MISSING LINK :internal Roche studies on isotretinoin (Roaccutane Accutane) and GI disorders, revealed during US litigation, show 21% of patients affected, similar to psychiatric effects. Global pharmacovigilance: 12% Gastro-Intestinal vs 12% depression. https://t.co/AgyQVRdt7a
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@doug_bremner @senateurJGM @VictimesRoac @serenatinari @CatherineRiva @PGzsche1 @profmelnik @acneaware @SimonBreidert @APRIL_charity @joannamoncrieff @CatherineRiva @RxISK @leoniefen @DrDavidHealy @RealBartStupak @RecheckHealth @RozennLeSaint @abcsoka @AVFIN_asso
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@doug_bremner @senateurJGM @VictimesRoac @serenatinari @CatherineRiva @profmelnik @AcneAware @SimonBreidert @APRIL_charity @joannamoncrieff @RxISK @leoniefen @DrDavidHealy @RealBartStupak @RecheckHealth @RozennLeSaint @abcsoka @AVFIN_asso Pre-approval studies by the drug maker (#isotretinoin) reported 21.6% GI side effects, and symptom onset delayed up to 1,219 days. If needed, details are on my profile, @senateurJGM.
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@MartinFierro769 @pfsnetwork @MediapartBlogs @apesac1 @afaCrohnRCH @VivreMieuxCrohn @APSSII @ArthritisFdn @AssociationSfc @LutteLupus @MaMyosite @AvecHashimoto @NMacFa @orsondj @PGzsche1 @ArthritisFdn @sep_avenir @LFSEP @AssoSdrcAlgo @MediapartBlogs @ABpfe
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@MartinFierro769 @pfsnetwork @MediapartBlogs @apesac1 @afaCrohnRCH @VivreMieuxCrohn @APSSII @ArthritisFdn @AssociationSfc @LutteLupus @mamyosite @AvecHashimoto @NMacFa @orsondj @sep_avenir @LFSEP @AssoSdrcAlgo @ABpfe @PGtzsche1
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Dozens of studies on depression. Zero on GI. Never published. Never replicated. Source : https://t.co/AgyQVRdt7a Image: summary table french and english. WHO pharmacovigilance.
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A 1982-era Roche study showed: Vesanoid (cancer use): 34% GI disorders Isotretinoin (acne): 21% This gap is far narrower than what official documents or product labels suggest.
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Comparative analysis between Tretinoin (anti-cancer) and Isotretinoin (anti-acne), 2021 https://t.co/onQU6m9uj3
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Another internal report (1982–1998) included clear challenge–dechallenge–rechallenge cases — a gold standard in pharmacovigilance. Still, these findings were never published or disclosed in scientific literature or drug safety info.
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Roche acknowledged a latency of up to 1,219 days (over 3 years) between isotretinoin use and symptom onset. This is not reflected in product labels, nor in post-treatment follow-up. How many cases were dismissed due to delayed onset?
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Global pharmacovigilance reports ~12% GI side effects — the same as for depression. But only psychiatric risks triggered studies, debate, and media attention. GI effects? Silence. We studied the golden egg. Never the goose.
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Correction: the 21% GI figure comes from Roche’s early internal data, not equivalent to pharmacovigilance. GI and psychiatric reports are both ~12% globally.
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Source: https://t.co/AgyQVRdt7a Table based on court exhibits in Rossitto v. Roche (N.J. App. Div., 2016, unpublished). Legal notice: This table is provided for informational, and public health purposes. It does not reproduce the full internal documents of the manufacturer.
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Case law on ulcerative colitis, IBD, suicide and RoAccutane https://t.co/4f37E1cO6o Jurisprudences Colites ulcéreuses, MICI, suicide et RoAccutane https://t.co/Bd5FMG814P
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