F.A.O. Pat O’mahony.
I am sending this e-mail to you despite the fact that I’m not sure you have taken much notice of my previous numerous e-mails. I have been asked…”Are you sure the I.M.B. are aware of all the information out there?” and “surely if they know, they will have to do something about this drug?” So just to pacify everyone, I will do it again!
As you already know I have serious issues with citalopram and what I believe are the very flimsy warnings that are attached to these types of drugs (ssri’s) in the patient information leaflets. The reason I have such issues is very simple, I know my son and what he was capable of, or not capable of in this instance. I believe that “Failure to warn” is a major flaw on your part considering the facts of the numerous warnings from the E.M.A. and the F.D.A. and of which I have already brought your attention to.
I believe an investigation should be instigated with citalopram but I also realise you don’t have to take my word for it, that’s why I’m drawing your attention to some coroners reports around the world particularly as the coroner at Shane’s inquest reported his findings as “of medical Importance”. As you may be aware the jury at my son’s inquest refused to return “a suicide verdict” and instead chose the only other option open to them…an open verdict.
The jury was obviously strongly influenced by the evidence of Professor David Healy and that of assistant state pathologist Dr Declan Gilsenan, who testified to “toxic” levels of citalopram in my son’s blood. Both doctors also stressed that the high levels of the drug were not necessarily due to an overdose, but could have resulted from a build-up of citalopram resulting from it being slower to metabolise in Shane’s body.
Prof Healy stated categorically that “it is the drug that causes the problem”, at least in susceptible patients who can form a small but significant minority. He added that the higher the dose taken, the greater the likelihood of serious adverse effects and behaviours. In my son’s case, the post mortem had shown levels of citalopram which lay between ‘toxic’ and ‘lethal’.
Professor Healy also stated “My view is that there should be compulsory monitoring of patients in the initial period after starting to take the drug,” he said. He explained that the danger period is generally within the first two weeks and usually within the first days of taking the drug. “As many as 50% of patients prescribed citalopram [the active ingredient in Cipramil and other brands] could find it is the wrong drug for them,” he said. “If they react to it, if there is any kind of oddity, they should go back to their doctor and … have the drug changed.”
There were a few of the usual psychiatrists who tried to refute his claims namely Patricia Casey and Timothy Dinan. As Patricia Casey has a long association with lundbeck and Timothy Dinan is also associated with lundbeck and has an advisory position with yourselves, you can take from that anything you want to! Also very interestingly both psychiatrists took separate actions against Dr.Michael Corry , the latter to the Irish Medical Council against Dr.corry for remarks that he made in association with my son. He said he would stake his reputation on the fact that Shane would not have done what he did if he wasn’t on anti-depressants.
As I have previously referred to, I would like to draw your attention to some coroner’s around the world that have serious issues with citalopram and its close relationship with suicide and homicide.
1. Recommendations of Magistrate Jacqueline M. Milledge Australia… (Senior Deputy State Coroner)
Inquest of Roxanne, Luke, Grace and Michael Richardson.
To the Minister for Health and the Therapeutic Goods Administration:
That the use of Citalopram in the treatment of depression be monitored and further studied to determine its effectiveness in the treatment of depressive illness and to guard against any side effects that may exacerbate a predisposition to violent behaviour.
2. Coroner Dr.Andrew Reid, St Pancras Coroner’s Court. U.K.
Inquest of Ian Fox.
“At his inquest on Thursday, Mr Fox’s wife, Maria Fox, blamed her husband’s sudden death on the drug, and a coroner ruled the ‘adverse effects’ of Citalopram had played a part.
“Coroner Dr Andrew Reid said he accepted that Mr Fox had jumped in front of the train, adding: ‘I’m satisfied he did so while the balance of his mind was disturbed while suffering the adverse effects of Citalopram.’”
3. Coroner Ian Smith Cumbria, U.K.
Inquest of Nigel Woodburn.
The retired bank manager, of Bardsea Green, south Cumbria, was killed at the wheel of his car on June 16, minutes after confessing to his wife he’d had suicidal thoughts. He had been prescribed Citalopram after becoming depressed through ill health.
Coroner Ian Smith is to write to the committee on the safety of medicines – an independent advisory body – following the inquest into the death of Nigel Woodburn. He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past. “Mr Smith returned a narrative verdict that Mr Woodburn died in a road vehicle collision.
4. Birmingham coroner Aiden Cotter U.K.
Inquest of Yvonne Woodley.
Birmingham coroner Aiden Cotter, called for more research into the drug after experts raised concerns over its side-effects.
A coroner has ordered an urgent investigation into an anti-depressant after it turned a mother-of-two into a ‘zombie’ before she was found hanged in her attic. Housewife Yvonne Woodley, 42, visited six GPs who increased her dosage of Citalopram in the months before her death.
5. Brecon coroner Geraint Williams.
Inquest of Stephen Leggett.
The FDA warning came too late for Stephen Leggett, according to his family. On March 15, 2004, just five days after he’d taken his first dose of citalopram for stress over work, the 53-year-old Taunton teacher killed himself by dousing himself in petrol and setting himself on fire.
Brecon coroner Geraint Williams said he was “profoundly disturbed” by the effect the drug had on Mr Whitfield. He took the first dose on Thursday and he killed himself on Monday.”
In March last year the US Food and Drug Ad- ministration issued a public health alert about a type of antidepressant which it said could lead to deeper depression and even suicide in some people.
It seems to fit a pattern seen in other deaths linked to this type of drug. CITALOPRAM (marketed by the brand name Cipramil in the UK) belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
I have attached Professor Healy’s report for your consideration. (Again)
Looking forward to hearing from you,
REPLY FROM THE IRISH MEDICINES BOARD…
SENT BY E-MAIL
1 April 2011
RE: Citalopram – IMB Case Ref 043226
Dear Mrs. Fennell,
Thank you for your most recent e-mail, dated 16 March 2011. We have studied the points you have raised and take this opportunity to respond.
As described in previous correspondence, the role of the Irish Medicines Board in respect of medicines licensing is to assess all available data on the safety, quality and efficacy of medicines and if authorised, to approve the product information for the doctor and for the patient. This information is subsequently updated following the evaluation of new data, as required. The product information is considered by the doctor in the context of their assessment of their individual patient’s clinical condition at the time of treatment and any particular risks identified.
We have previously outlined the specific product information currently in place for the class of medicines to which citalopram belongs (known as the SSRIs) and would like to clarify that this information reflects the outcome of a number of EU reviews and evaluations of the data, at which the IMB has participated within the European Medicines Agency. These reviews took account of the US data and resulted in a common wording, applicable across all EU member states. The specific warnings are included in section 4.4 of the summary of product characteristics (the information for the doctor) and in section 2 of the package leaflet for the patient.
As mentioned too, following the last review, the IMB required the relevant companies to update the product information for the doctor and the patient. We also highlighted this information to all doctors and pharmacists via our Drug Safety Newsletter (edition 28, previously provided and available at 20September2008.pdf) which is sent to healthcare professionals.
All medicines are subject to ongoing monitoring following authorisation through various methods, including the spontaneous adverse reaction reporting system, regular review of cumulative safety data, evaluation of additional clinical trial and other study data and worldwide published literature. Through such monitoring, reports including those provided by coroners in other jurisdictions are reviewed and evaluated, following notification to the relevant national competent authority. This system of monitoring supports ongoing review and assessment of medicines to determine whether their benefits continue to outweigh the risks for the populations of patients treated according to the approved conditions for use.
You have mentioned in your e-mail a member of an advisory committee of the IMB. As previously indicated, under the Irish Medicines Board Act, all experts who are members of advisory committees are required to declare their interests in any industry regulated by the IMB, including the pharmaceutical industry. At all advisory committee meetings, committee members must again declare any potential conflicts in relation to any item on the agenda. They are not permitted to participate in any discussions or decisions relating to a potential conflict and must absent themselves from that part of the meeting.
I hope this information is helpful and clarifies your outstanding queries.
Dr Caitriona M. Fisher (on behalf of Pat O’Mahony, Chief Executive)
Manager, Chief Executive’s Office
Irish Medicines Board