Malcharist

August, 3, 2020 | 3 Comments

Comments

  1. I haven’t read this fantastically clever exposure yet but in the meantime a top seller – teller of tall tales, Janssen and Jansen has added another chapter to Spravato the Wonder Drug
    (see Spravato on Rxisk blog)

    BRIEF—FDA approves new use for Spravato

    The US Food and Drug Administration has approved the supplemental new drug application (sNDA) for Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

    The sNDA was submitted by Johnson & Johnson subsidiary Janssen.

    Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours, providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect.

    The sNDA approval is based on two identical Phase III clinical trials in which Spravato plus comprehensive standard of care demonstrated a significant, rapid reduction of depressive symptoms within 24 hours, with some patients starting to respond as early as four hours.

    Spravato plus comprehensive standard of care led to a 15.9 and 16.0 point decrease on the Montgomery-Åsberg Depression Rating Scale (MADRS), a tool used to assess severity of depressive symptoms, in the two trials at 24 hours after the first dose of study medication.

    CNS DiseasesFocus OnJanssenJohnson & JohnsonNeurologicalPharmaceuticalRegulationSpravatoUS FDAUSA
    Twitter Facebook LinkedIn Google+
    Janssen, Johnson & Johnson, Spravato, sNDA, Depressive disorder, Ideation, Suicidal, Behavior

  2. recovery&renewal Retweeted

    Leonie
    @leoniefen
    ·
    1h

    @RxISK
    @AntiDepAware

    Accutane/ Roaccutane in the news once again, 24 years after Irish dad lost son to
    @Roche drug. Two bereaved mothers share a shattering warning after an acne drug https://mol.im/a/8613003 via
    @MailOnline

    https://www.dailymail.co.uk/health/article-8613003/Two-bereaved-mothers-share-shattering-warning-acne-drug.html

    AntiDepAware
    @AntiDepAware
    ·
    1h

    Antidepressants are not the only prescription drugs that can induce young men to take their lives.
    #Lamotrigine

    https://www.thenorthernecho.co.uk/news/18640996.parents-fear-change-medication-casued-suicide/?ref=twtrec

    The family also referred the coroner to information from the drug maker GlaxoSmithKline, which shows the increased risk in suicidal ideation is known and that warnings should have been given to Viktor and his parents.

    The company estimates there is one case of suicidal thinking or behaviour for every 530 patients treated and said there were four suicides in drug-treated patients during trials.

  3. David has described the case of A.C. Under ‘Stephen O’Neil and Doxycycline’
    A.C. refers to Alana Cutland whose distressing death was all over the Sun and covered by the BBC.
    The Coroner has made a Regulation 28 Report.

    Regulation 28: REPORT TO PREVENT FUTURE DEATHS (1)
    NOTE: This form is to be used after an inquest.
    REGULATION 28 REPORT TO PREVENT DEATHS
    THIS REPORT IS BEING SENT TO:
    Medicines and Healthcare Products Regulatory Agency
    10 South Colonnade, Canary Wharf, London E14 4PU.
    1 CORONER
    I am Tom OSBORNE, Senior Coroner for the area of Milton Keynes
    2 CORONER’S LEGAL POWERS
    I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and
    regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.
    3 INVESTIGATION and INQUEST
    On 28/08/2019 I commenced an investigation into the death of Alana Molly CUTLAND aged 19.
    The investigation concluded at the end of the inquest on 30 April 2020. The conclusion of the
    inquest was:
    I a Traumatic Injuries Following a Fall From A Plane
    I b
    I c
    II
    4 CIRCUMSTANCES OF THE DEATH
    On the 25th of July 2019 the deceased open the door of a light aircraft that was flying from
    Anjajavay to Antananarivo in Madagascar and fell to her death. She was a student from Cambridge
    University carrying out research on the island. She had taken doxycycline as an antimalarial
    medication and it is believed that she suffered a psychotic/delirium event that led to her behaviour
    and death.
    5 CORONER’S CONCERNS
    The MATTERS OF CONCERNS are as follows:
    The deceased was prescribed doxycycline as an antimalarial medication for used whilst in
    Madagascar. It was quite apparent from the evidence that she had a psychotic reaction as a result
    of taking the drug and yet there is nothing on the drug information leaflet that either highlights or
    mentions this possibility. If she or her parents have been aware of this possible side-effect they
    may have been able to intervene earlier to avoid her death. In my view the information sent out with
    the drug should be reviewed.
    6 ACTION SHOULD BE TAKEN
    In my opinion action should be taken to prevent future deaths and I believe you (and/or your
    organisation) have the power to take such action.
    7 YOUR RESPONSE
    You are under a duty to respond to this report within 56 days of the date of this report,
    namely by 30 September 2020. I, the coroner, may extend the period.
    Your response must contain details of action taken or proposed to be taken, setting out the
    timetable for action. Otherwise you must explain why no action is proposed.
    8 COPIES and PUBLICATION
    I have sent a copy of my report to the Chief Coroner and to the following Interested Persons;
    The family of Miss Cutland.
    I have also sent it to Professor David Healy and Dr Andrew Marriott, who may find it useful or of
    interest.
    I am also under a duty to send the Chief Coroner a copy of your response.
    The Chief Coroner may publish either or both in a complete or redacted or summary form. He may
    send a copy of this report to any person who he believes may find it useful or of interest. You may
    make representations to me, the coroner, at the time of your response about the release or the
    publication of your response by the Chief Coroner.

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