Newspaper and internet articles, Random

Dr Sherif (Hippocrates) Sultan.

Hipp

Remember Hippocrates?

Primum non nocere  – “first, do no harm.”

An article in today’s Irish Independent entitled ‘HSE Gags Surgeon After Cholesterol Drug Claims’ has truly shocked me to the core. The article tells the sorry tale of a leading surgeon who is gagged for giving his informed opinion. The HSE is Irelands’ Health Service Executive. Its Code of Governance states:

“The Health Service Executive (HSE) was established under the Health Act 2004 as the single body with statutory responsibility for the management and delivery of health and personal social services in the Republic of Ireland. As outlined in the Health Act, 2004 the objective of the Executive is to use the resources available to it in the most beneficial, effective and efficient manner to improve, promote and protect the health and welfare of the public.”

Dr Sherif Sultan, a leading vascular surgeon at University College Hospital Galway, researched a number of statin studies and concluded that they may do more harm than good in healthy people. He found there was a lack of evidence to show they should be given to healthy people and therefore avoiding the risk of statins’ side effects. Commenting in the Independent, Dr Sultan said: “I have received an official warning from the HSE and have been instructed not to liaise directly with the press in my capacity as a HSE consultant.” Today is a bad day for human rights in Ireland. Surely the HSE is violating this man’s Constitutional right to ‘freedom of expression’, not to mention Irish Citizens right to ‘Bodily Integrity’?

Statins adverse effects can include increased risk of Diabetes, Impotence, Acute Renal Failure, Myalgia and Severe Memory Loss. Last year the FDA (US Medicines Regulator) added diabetes and memory loss warnings to all statins. So Dr Sultan is right to be concerned. It begs the question; is our Government running the HSE or is Big Pharma pulling the strings once again? He further stated that analysis by the ‘British Medical Journal’ showed the superiority of exercise over drug therapy. Imagine saying exercise was superior to a possibly dangerous drug? Put him in the stocks; seriously gag the man, he’s lost the plot!

Statins are the most prescribed medications drugs globally, meaning Dr Sultan is going up against a multi billion dollar industry. A quick search through David Healy’s RxISK website reveals, among other things: 6264 cases of Myalgia, 1879 deaths, 783 cases of Acute Renal failure, 908 cases of Depression and 653 cases of Memory impairment, all reported as an adverse effect of taking Pfizers’ Lipitor. It is common knowledge that the numbers of adverse effects is seriously under-reported and the above numbers are for just one of the Statin drugs.

Cardiologist Pat Nash of the ‘National University of Galway’ contradicted Dr Sultans position and was quick to ‘reassure patients that statins are safe’. 1879 deaths is not what I’d call safe Dr Nash. I’m sure his argument has nothing to do with the support that NUIG receives from Pfizer, Lilly, GlaxoSmithKline and MSD pharmaceuticals, or its research links with Lundbeck!

I wonder what our grandparents would have thought about doctors medicating healthy people, and that we were buying into it? I know what mine would have said. ‘Cyclafeetis!’ I think it is we who have lost the plot! Good on ye Dr Sultan.

Philippe Pinel 1745-1826 (Plagurised from RxISk.org): “there is an art in medicine in knowing when to treat but an even greater art in knowing when not to treat.”

Independent Article.

HSE Code Of Governance.

Statin Induced Amnesia; RxISK.org

Reported Adverse Effects.

Newspaper and internet articles, Random

Why would anyone defend the use of Lariam?

Sgt. Robert BalesRTE’s Prime-time (Irish National Broadcaster) tackled the issue of Lariam-induced suicides within the Irish army on May 23rd. The programme can be viewed here.

For those who are not aware of Lariam (aka Mefloquine), it is a highly controversial anti-malaria drug used within the defense forces when deployed overseas. The drug can cause many serious adverse effects and numerous families have blamed it for their loved one’s suicide. Interestingly, it comes 5th in the PLOS ONE ‘Prescription Drugs associated with violence’ study (after Champix and Seroxat). The US army stopped the use of Lariam following numerous suicides and severe psychiatric reactions associated with its use. Tragically, for all concerned, this drug has been implicated in the massacre of 17 Afghan citizens including children by Sgt. Robert Bales (pictured) on March 11, 2012. His wife said “I have no idea what happened, but he would not – he loves children. He would not do that.

A few weeks after the Prime-time programme (which included grieving families and their harrowing testimonies), I was disappointed to see the Minister for Defence, Alan Shatter, defending Lariam in the media. He defended the use of the drug, disputing its links to suicide and said “There is no evidence in any of the coroners’ inquests linking any deaths to Lariam.” He seemed to have completely undermined the Prime-time programme and it made no sense to me. Why would he do that?

Sorry but I have no answers to Minister Shatter’s involvement but I do have a very recent warning (8th July 2013) from Roche Pharmaceuticals which the Minister might find embarrassing. The link can be found here but Minister Shatter might find the excerpt below interesting.

Lariam

Minister Shatter said of the nine cases of lariam suicides” “given the limited period of time during which Lariam remains in the bloodstream, according to our expert advice, it is extremely unlikely that the product could have been a contributory factor in practically all of these cases”. Irish Times June 19th. The following excerpt may help him a little bit with that one:

Lariam 1

Roche, who originally marketed Lariam, is no stranger to controversy, having also invented the notorious acne drug Accutane. This drug is also widely linked to suicide and following numerous lawsuits in 2009 Roche pulled the drug from the US market. The Irish Medicine’s Board still allow it though despite a high profile court case involving a courageous Irish father here. Roche’s corruption and intimidation tactics were subsequently captured in Doug Bremner’s ‘Before You Take That Pill’.

What I do find interesting is why Roche came out with the warning now. Was it pressure from the Prime-time documentary? Was it pressure from the pharma-funded Irish Medicine’s Board? I doubt it! But one thing is for sure, it was not out of the goodness of Roche’s pharma heart.

Lariam 2

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Army reviews notorious drug after Afghan massacre

PLOS ONE ‘Prescription Drugs associated with violence’ 

US Army curbs Lariam

cipramil (celexa) stories,, lundbeck, Newspaper and internet articles

Panorama Expose on Citalopram use in Pregnancy.

Unhappy pill

Next week BBC’s Panorama team are tackling the issue of antidepressant use in pregnancy. The programme will be broadcast on Mon 1st july, entitled ‘The Truth About Pills and Pregnancy‘.

According to the UK Independent “The programme will broadcast an interview with Anna Wilson, whose son David spent the first five weeks of his life in hospital. A 20-week scan had shown that David had a heart defect and would need surgery immediately after being born. Anna had been taking the prescription drug Citalopram to treat her anxiety four years before her pregnancy began, and was told that she was safe to continue whilst pregnant. The show will feature interviews with Prof Pilling, who will say that GP prescription guidelines are about to be updated to take into account evidence suggesting a link with SSRIs and heart defects.”

A manufacturer contacted by the BBC denies any link to major foetal malformations (no prizes for guessing Lundbeck here).

Panorama spoke to eight mothers who had babies born with serious heart defects after taking a commonly used SSRI (selective serotonin reuptake inhibitors) antidepressant while pregnant.

An article on BBC News stated “Lundbeck, the manufacturer of Citalopram, said a recent review of scientific literature concluded that the drug ‘does not appear to be associated with an increased risk of major foetal malformations’.”

It seems that Lundbeck are lying again or there is a serious lack of communication between the various medicines regulators and the pharmaceutical industry. Below is an adverse reaction report logged with the Irish Medicines Board involving a baby born with a Cleft Lip, associated with the mother’s use of Citalopram.

IMB 1

What about the following, also reported as Citalopram induced? This particular report concerns the intrauterine death of an unborn baby due to ‘Citalopram exposure during pregnancy’.

IMB 3

Then there was our meeting in Copenhagen with the two Lundbeck goons. We asked if Citalopram/Escitalopram was a teratogen. Their answers (or non-answers) may surprise you…

Leonie                       Right, will I go on because there’s no point, we’re stuck at that one?  Anyway.  Do you think that it’s advisable to virtually bathe foetuses in Serotonin given it is now accepted this family of drugs are firmly associated with birth defects?

Dr. Madsen               Virtually bathe?

Leonie                       Foetuses in Serotonin – pregnancy.

Tony                         Pregnant women.

Dr. Madsen               I don’t know what you mean by virtually bathe

Leonie                       I’m talking about anti-depressants are known to cause birth defects.  If you think so, would it not be better if women of child-bearing age were cautioned against, perhaps even contra-indicated from using this drug?  Citalopram or Escitalopram?

Dr. Madsen               Em, I think in…..

Leonie                       Your views?

Dr. Madsen               In pregnancy?

Leonie                       Yeah

Dr. Madsen               Em, I think em, physicians need to double their efforts to make sure that there is a correct risk versus eh, benefit eh, assessment of the em, of any action.

Leonie                       Is Citalopram and Escitalopram a teratogen?

Dr. Madsen               Em, meaning, what, what, what do you mean?

Leonie                       Can it cause harm to foetuses? Unborn babies.

Dr. Madsen               Em, obviously, in order to have our compounds approved we have done em, a large number of pre-clinical trials em, and we are constantly monitoring and the eh, while the recommendation I believe throughout, is to be, be extra cautious when administering any eh, medications to pregnant women…

Leonie                       Can it cause harm?….. to unborn babies?

Dr. Madsen               Anything can cause harm, can cause harm in any dose

Leonie                       So yes it can.

Dr. Madsen               depending on dose

Leonie                       Yep

Em, why if it can cause harm, is this not clearly, clearly stated on the packaging and information leaflet?

Mr. Schroll                Do you talk about the patient leaflet or do you talk about the SPC, the label that the Doctors use in order to prescribe the medication?

Leonie                       I’m talking about a pregnant woman that goes down and gets it in the chemist.  Is it on the patient information leaflet?

Mr. Schroll                In the patient leaflet it says you have to talk to your Doctor….

Leonie                       And what does it say in the Doctor’s leaflet?

Mr. Schroll                That he has to be extra cautious.  I think that if you go to the… to, to the Irish home page, I believe it is like that, it’s like that in Denmark and elsewhere.  If you go to the medicines agency authorities

Leonie                       So,

Mr. Schroll                the medicines agency authorities you can see what is in the checks that the Doctors and that is up to them to decide…..

Leonie                       So you are passing the buck back to the Doctor again.

Mr. Schroll                I think when it’s prescription medication, yes.  If it was eh, eh,

Leonie                       And will they be told that it can harm their unborn baby?

Mr. Schroll                Sorry?

Leonie                       Will the pregnant woman be told that the drug can, can harm her unborn baby?

Mr. Schroll                It would be part of the discussion to talk about the risks and the benefits and that would be up to the Doctor.

Leonie                       It would be up to the Doctor to tell them that the drug can harm their unborn baby?

Mr. Schroll                Eh, now, you’re talking…..

Leonie                       It’s not up to Lundbeck, no?  It’s up to the Doctor to tell the woman that the drug can harm their unborn baby?

Mr. Schroll                To be cautious, yes, yes.

The Irish word ‘amadáin’ springs to mind. I could think of a few English ones too but think I’d better refrain. The Panorama programme should be excellent viewing as usual, particularly with Shelley Jofre as reporter. She did the previous expose concerning GSK and Seroxat suicides. I can see her putting Lundbeck in their place.

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Lundbeck Meeting here.

IMB adverse reaction reports.

MHRA (UK) adverse reaction reports.

Newspaper and internet articles, Our story.

IMB; Ireland’s Grunewald?

Checkpoint Charlie

Forgive my ramblings here; it may be attributed to another of my ‘bereaved mother’ episodes.

In his latest post, Professor David Healy stated that in the two months since RxISK was set up, it has had more patients report effects than the ‘Pharma funded’ Irish Medicine’s Board (IMB) has had in the last three years. Now a cynic such as I would believe that the huge discrepancy here, is precisely because the IMB is funded by the Pharmaceutical industry. There is no incentive to encourage adverse reaction reporting; why bite the hand that feeds you?

The IMB are letting people down; I know the IMB let my son down. Where is the information that SSRI drugs can cause worsening depression, suicide, aggression, mania and birth defects? How many deaths could have been saved if this information was made public, to the public, by the IMB?

It has been a strange few weeks for us. We went to Berlin last week as I thought it would be a good idea to introduce my children to Germany and it’s tragic history. Despite it’s history, maybe because of it’s history, it really is an amazing City and they had a great time. The Germans we met were lovely, helpful and loved chatting to the smaller ones. One of the most profound and weird experiences was our trip to Grunewald station. Tony and I went with Lucy, 5, as the lads wanted to go elsewhere; the ‘Trabant’ museum.

More than 50,000 Jewish Berliners were transported from Grunewald station, platform 17, to various concentration camps including Auschwitz, mostly to their deaths. To say Grunewald station is an awful, awful place is a terrible understatement for the 50,000 innocent victims. The three of us stood on platform 17, alone, with not another person in sight and thought about the victims and Shane, always thinking of Shane. He is on my mind and in my heart from the minute I wake until my dreams. Our lives have changed irrevocably since he died and we are not the same people that we were before 2009.

Anyway, back to Grunewald; we wondered how this was allowed to happen, not hundreds of years ago, but a short 70 years ago? Lucy of course was too young to understand the enormity of Grunewald but as sometimes happens with the sixth sense of small children, she refused point blank to stand near the track and just wanted to go home.

Tony took this picture when we weren’t looking; I find it really hard to look at. What of all the mothers, fathers, daughters and sons who stood on the same track, in the same spot, who were subsequently mass murdered by the Nazis?

I would liken the IMB to an Irish Grunewald, where it has actively allowed innocent and unsuspecting people to be transported to their deaths, not via a train, instead via pills. RxISK having had more adverse reaction reports in 2 months than the IMB has had in 3 years, is an absolute disgrace! The IMB; Protecting the Irish people or protecting the drug industry?

…………

https://leoniefennell.wordpress.com/2011/07/17/conflict-of-interest-in-irelands-drug-regulator-the-imb/

Random

Your Country needs you!

Shane was always fascinated with this poster and in fact bought it shortly before he died. It turns out that the man in the picture is an Irishman (Lord Kitchener). Anyway, before I digress, I’ll get to the point, shall I?

The people of Ireland need you.

I have said before that I think the pharma funded ‘Irish Medicines Board’ (IMB) are pretty useless. Their ‘yellow card system’ for the reporting of an ‘adverse drug reaction’ was notoriously underused and difficult to access. Here’s an example of instructions from a 1997 ‘Drug Safety Newsletter’ before the invention of their (pharma funded) website. It is widely known that there is a very serious problem of underreporting in most countries, including Ireland and that very few adverse reactions actually get as far as the IMB’s database. Reporting an adverse reaction saves lives and is the only way to make medicines safer for us all.

Did you know Shane’s ‘adverse drug reaction’ was reported to the IMB? It wasn’t reported by a doctor though; nope, it was by a journalist! Hmm.

If you are having, or have had an adverse reaction to any drug, whether or not it seems trivial to you; please do me a favour and report it to (the non-pharma funded) RxISK website. Who knows how many lives can be saved? Just click on the picture and report; it will take about 2 minutes.

Why report? According to the RxISK website: “Drug side effects are now a leading cause of death, disability, and illness. Experts estimate that only 1–10% of “serious” adverse events (those causing hospitalization, disability, or death) are ever reported. Not to mention the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s concentration, functioning, judgment, and ability to care.

RxISK is the first free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect — identifying problems and possible solutions earlier than is currently happening.”

Go on, your Country needs you!

Newspaper and internet articles, psychiatry, Random

‘Mother and Son’ both die by suicide.

I cannot tell you the amount of parents who have lost their children to suicide and have subsequently been prescribed ‘antidepressants’ by their family GP. What the pill is supposed to do is beyond me; un-dead the child maybe?

The tragedy of this casual prescribing is this: If a person has an adverse reaction to an antidepressant and goes on to die by suicide; the chances are that his/her family members may also have a ‘genetic predisposition’ to having an adverse reaction. Professor Healy warned me of this after Shane’s Inquest but it seems that most doctors are unaware of it.

Here’s an article in the ‘Mail Online‘ which reports on an Inquest in 2010. The article reports on the death of a young man, aged 24, and the subsequent death (2 months later) of his mother, aged 59. This young man jumped off the Humber Bridge (Lincolnshire/East Yorkshire) on his 24th birthday and two months later his mother jumped off the same bridge.

The most important sentence in the article is this “Both Mrs Brown and her son had been put on anti-depressants by their GP before they died, the inquest heard”

Did this young man and his mother have an adverse reaction to antidepressants? What good was antidepressants going to do for a grieving mother and why are doctors not aware of this genetic predisposition? Is Professor Healy the only one with this information or the only one who cares?

claire-peake-another-victim-of-unhappy-pills

cipramil (celexa) stories,, psychiatry, Shanes story.

Are psychiatrists just idiots in Ireland or is it a global phenomenon?

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Here is two ‘Irish College of Psychiatry’ statements regarding SSRIs and Shane’s inquest in the summer 2010 newsletter. Naturally the statements deny that suicide or homicide can be a side effect of antidepressants. Protecting their medical model once again! Keep dishing out mind altering drugs; what’s a few dead people when pills = money?

Now I know everyone is entitled to their own opinion, but surely “best practice” for doctors who have spent years studying medicine is not to bury their heads in the sand and ignore all the evidence. This is not me trying to justify what happened to Shane. This is about letting people know about the side effects of this medication (SSRIs).

I cannot tell you why psychiatry Ireland are trying so hard to suppress the mounting evidence of suicide/homicidal events relating to SSRIs but I can give you the evidence as I see it.

Summer 2010

College of psychiatry Ireland Newsletter.

 

“As communicated recently to our members, the college did not issue a detailed statement during two recent inquests where evidence linking antidepressant use with self-inflicted death and the death or injury of others was presented. We have now issued a full statement to all print and broadcast media outlining clearly our position and disquiet on the speculative nature of this evidence.

The statement is available on our website (www.irishpsychiatry.ie) and was emailed to all members. Thank you to all those involved in the whole process to compile this important piece.”

DR. Justin Brophy, President.

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CLARIFICATION ON ANTIDEPRESSANT MEDICATION.

“In the past month there has been considerable discussion in Ireland  of suicidality and homicidality as potential adverse effects of selective serotonin reuptake inhibitors (SSRI) antidepressant medication. Much of this discussion has been speculative.

Clearly, suicide and homicide are events of the utmost gravity and any possible role of any  treatment  in precipitating such tragedies warrants the most thorough investigation. However, discussion of the risks involved must be based on evidence rather than conjecture or unfound opinion.

Untreated depression can have a fatal outcome. Those experiencing moderate-to-severe depression frequently describe having thoughts of self-harm.  Antidepressants are effective in the treatment of depression. The effective treatment of depression is an important means of reducing suicide rates.

A high volume of research in recent years has failed to establish a causal link between antidepressant use and suicide. At an individual level, the period early in treatment may be a time of relatively high risk, as treatment tends to start when the person’s depression is severe and treatment takes some weeks to work. As treatment takes effect and energy and motivation return, people who have recently commenced antidepressant treatment may be more able to act on suicidal thoughts that are inherent to their condition. That the early recovery period is potentially a period of increased risk for suicidality is something of which all doctors should be aware. The college of psychiatry of Ireland, in unison with the Irish medicines board, recommend close monitoring of all individuals commenced on antidepressant therapy.

There is no evidence of a link between antidepressant use and homicide.

A more detailed statement articulating the issues is attached and available on the website of the college of psychiatry of Ireland,  http://irishpsychiatry.ie”

These are the actual facts..

1. Ssri’s with homicidal ideation  listed as an adverse reaction on patient information leaflet- paxil (canada), zoloft (canada), effexor and luvox.

2. Listed side effects on Irish patient information leaflet for cipramil.. agression, depersonalisation,hallucination, mania and reports of “thoughts of harming or killing yourself”.

3.  The FDA officially extended the age group for the black box warning about antidepressant inducing suicidal thinking and behavior from 18 to 24.

4. Irish medicines board..Informaton from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

5. Lundbeck letter states reports of self harm and harm to others with cipramil.

6. Irish medicines board..Under 18’s suicide related behaviours ( suicide attempt and suicidal thoughts) and hostility ( predominantly agression, oppositional behaviour).

7. The European Medicines Agency’s scientific committee concluded that all SSRI and SNRI antidepressants were associated with increased suicide-related behavior and hostility in young people.

8. The Commission of the European Communities issued the strongest warning yet against child antidepressant use as the drugs caused suicidal behaviour including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.

9.  Japan’s National Health Ministry directed pharmacy companies to revise labeling to warn that antidepressants could cause suicide.

10. Wikipedia..In the United States, citalopram, like other antidepressants, carries a black box warning stating that it may increase suicidal thinking and behaviour  in those  under age 24.

11. A recent publication of the top 31 drugs that are disproportionately linked with violent behavior.  5 in the top 10 were antidepressants.

Surprise, Surprise –11 of the 31 were antidepressants!     Cipramil (celexa) came 16th.

 

 

E-MAIL TODAY..

Excerpts from the minister for mental health’s e-mail to me today. Surprise surprise, he’s far too busy to meet up with me but I suppose I should be thankful that he finally got around to replying to my numerous e-mails!

Dear Ms Fennell

9th February 2011

“John Moloney, Minister for Disability and Mental Health has asked me to thank you for your email dated 6th January, 2011. Unfortunately, due to diary commitments, the Minister is unable to meet with you in the near future.

The letter also referred to the IMB’s Drug Safety Newsletter in late 2008, which stated that a review was undertaken at EU and US level to assess the risk of suicidality in adults treated with antidepressants. The review concluded that young adults may be at an increased risk of suicidal behaviour when treated with antidepressants.

As a result of this review, it was agreed at EU level that the product information for all antidepressants should be further updated to more fully reflect the current evidence regarding the potential risk of suicidal behaviour with antidepressants.”

Random

Off-label prescribing for children in Europe.

 

Off-label, unauthorised Rxing (prescribing) in children “widespread” in Europe

Lynne Taylor  World News | January 27, 2011

(Excerpt)

“The prescribing of off-label and unauthorised medicines to children is still widespread in Europe, accounting for 45%-60% of total prescriptions in both inpatient and outpatient care, says a new report from the European Medicines Agency (EMA).”

This article goes further to say that the study notes that the therapeutic classes that are used most frequently off-label or without a marketing authorisation are among others.. contraceptives, antibiotics and ssri anti-depressants. 

There are reasons why ssri’s are not licenced for children. (The warnings have been upped to age 25 buts that’s another story) The E.U. has published these warnings/side effects for under 18’s taking ssri’s..

Age: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide, Aggression, Violence, Hostility. 
IS THAT NOT ENOUGH OF A REASON NOT TO PRESCRIBE THESE DRUGS TO CHILDREN? ARE THE RISKS NOT SERIOUS ENOUGH?

 

 

 

It’s not just Americans who have to deal with the fall-out from off label prescribing, the side effects are the same for european children. But is it just American pharmaceutical companies that are fined for improper conduct?

 

 Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Why: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received a $313 million penalty.  The settlement also covered Forest’s off-label use of Celexa for children’s use.

 
 
 
 
Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Why: Allergan’s was fined $600 million by the Department of Justice. The settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy. 
 
Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Why:  J&J received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.
 
GlaxoSmithKline
With: U.S. Attorney’s office in Colorado
When: Jan. 29, 2009
Why: After seven years of off-label promotion on nine of its best-selling drugs, GlaxoSmithKline (GSK) was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.
 
Pfizer
With: Department of Justice
When: Jan. 26, 2009
Why: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion for off-label promotions of its COX-2 drugs.
 

 Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Why: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

 

 

 

 

 
 January 2009
 European UnionDrug Class: Newer Antidepressants, Older AntidepressantsAge: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide
Summary: The Pharmacovigilance Working Party (a party that provides advice on the safety of medicinal products and on the investigation of adverse reactions associated with medicinal products authorized in the European Union) recommended an update to product labeling and all antidepressants patient information leaflets to include information on the increased risk of suicide for children to young adults.
Source: “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, January 2006.
 
August 19, 2005
European UnionDrug Class: Newer AntidepressantsDrug Name: Fluoxetine, Fluvoxamine, Sertraline, Paroxetine, Citalopram, Escitalopram, Atomoxetine, Duloxetine, Venlafaxine, Mianserin, Milnacipram, Reboxetine, Mirtazapine
Age: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide, Aggression, Violence, Hostility
Summary: The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child antidepressant use as recommended by Europe’s Committee for Medicinal Products for Human Use (CHMP).
Clinical trials had shown that the drugs caused suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.
Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.